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A Phase II, Dose Ranging Study Of CP-690,550 Eye Drops In Patients With Dry Eye Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01135511
Recruitment Status : Completed
First Posted : June 2, 2010
Results First Posted : May 7, 2013
Last Update Posted : May 7, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Dry Eye Syndromes
Interventions Drug: CP-690,550 Eye drops
Drug: CP-690,550 Eye drops-vehicle
Drug: Sodium Hyaluronate
Enrollment 285
Recruitment Details  
Pre-assignment Details In this study, during the 2-week run-in period, enrolled participants were administered artificial tears 4 times daily after signing informed consent.
Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan CP-690,550 Eye Drops Vehicle Group in Korea CP-690,550 Eye Drops 0.001% Group in Korea CP-690,550 Eye Drops 0.003% Group in Korea CP-690,550 Eye Drops 0.005% Group in Korea
Hide Arm/Group Description At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
Period Title: Overall Study
Started 41 42 41 40 39 21 19 21 21
Completed 41 39 33 37 38 20 18 20 20
Not Completed 0 3 8 3 1 1 1 1 1
Reason Not Completed
Adverse Event             0             1             2             0             0             1             0             1             0
Lack of Efficacy             0             1             1             2             0             0             0             0             0
Protocol Violation             0             0             3             0             0             0             0             0             0
Pregnancy             0             0             0             1             0             0             0             0             0
could not visit the clinic             0             1             2             0             0             0             0             0             0
noncompliance with study drug taken             0             0             0             0             1             0             0             0             0
Withdrawal by Subject             0             0             0             0             0             0             1             0             1
Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan CP-690,550 Eye Drops Vehicle Group in Korea CP-690,550 Eye Drops 0.001% Group in Korea CP-690,550 Eye Drops 0.003% Group in Korea CP-690,550 Eye Drops 0.005% Group in Korea Total
Hide Arm/Group Description At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. Total of all reporting groups
Overall Number of Baseline Participants 41 42 41 40 39 21 19 21 21 285
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 41 participants 42 participants 41 participants 40 participants 39 participants 21 participants 19 participants 21 participants 21 participants 285 participants
Between 18 and 44 years 14 14 11 11 11 5 8 7 3 84
Between 45 and 64 years 9 14 12 16 14 10 8 13 10 106
>=65 years 18 14 18 13 14 6 3 1 8 95
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 42 participants 41 participants 40 participants 39 participants 21 participants 19 participants 21 participants 21 participants 285 participants
Female
32
  78.0%
39
  92.9%
37
  90.2%
33
  82.5%
34
  87.2%
20
  95.2%
16
  84.2%
20
  95.2%
19
  90.5%
250
  87.7%
Male
9
  22.0%
3
   7.1%
4
   9.8%
7
  17.5%
5
  12.8%
1
   4.8%
3
  15.8%
1
   4.8%
2
   9.5%
35
  12.3%
1.Primary Outcome
Title Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8
Hide Description

Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.

Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan CP-690,550 Eye Drops Vehicle Group in Korea CP-690,550 Eye Drops 0.001% Group in Korea CP-690,550 Eye Drops 0.003% Group in Korea CP-690,550 Eye Drops 0.005% Group in Korea
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
Overall Number of Participants Analyzed 41 42 41 40 39 21 19 21 21
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-3.0  (2.1) -3.0  (2.8) -3.0  (2.5) -3.1  (2.6) -3.2  (2.4) -2.4  (2.4) -3.0  (2.7) -2.8  (1.9) -2.2  (2.5)
2.Secondary Outcome
Title Changes in Corneal Staining Scores for Study Eye From Baseline
Hide Description

Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.

Time Frame Baseline, Week 1, 2 and 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: Participants who received at least 1 dose of study treatment.
Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 41 42 41 40 39
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 -2.1  (1.9) -1.9  (2.1) -1.9  (2.1) -1.6  (2.0) -2.0  (2.0)
Week 2 -2.4  (1.8) -2.4  (2.0) -3.2  (1.8) -3.0  (2.0) -2.8  (2.1)
Week 4 -2.7  (2.0) -3.0  (2.7) -3.2  (2.4) -3.3  (2.5) -2.6  (2.1)
3.Secondary Outcome
Title Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye
Hide Description

Percentage of participants demonstrating corneal staining score = 0 which indicates no damage in corneal surface.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Time Frame Week 1, 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data at Week 8.
Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 41 42 41 40 39
Measure Type: Number
Unit of Measure: Percentage of participants
Week 1 (n=41, 41, 40, 40, 39) 4.9 2.4 5.0 0 0
Week 2 (n=40, 41, 39, 40, 39) 2.5 2.4 5.1 7.5 2.6
Week 4 (n=41, 40, 35, 40, 38) 12.2 5.0 8.6 7.5 2.6
Week 8 (n=41, 41, 40, 40, 39, LOCF) 12.2 4.9 7.5 7.5 0
4.Secondary Outcome
Title Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline
Hide Description

Based on the Oxford grading system, the bulbar conjunctiva of each eye was divided into 2 different zones (nasal and temporal). The nasal and temporal bulbar conjunctival zones were each graded independently using a 6-point scale (0 [Absent] to 5 [Severe]). Total score ranged from 0 (Absent) to 10 (severe), higher score=higher damage to eyes due to dryness. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement.

Time Frame Baseline, Week 1, 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 41 42 41 40 39
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 (n=41, 41, 40, 40, 39) -0.8  (1.9) -0.7  (1.8) -0.6  (1.3) -1.1  (1.7) -0.6  (1.7)
Week 2 (n=40, 41, 39, 40, 39) -1.0  (2.2) -0.8  (2.0) -0.7  (1.5) -1.7  (2.5) -1.0  (2.1)
Week 4 (n=41, 40, 35, 40, 38) -1.2  (2.2) -1.0  (1.7) -0.8  (1.5) -2.0  (2.4) -1.1  (2.2)
Week 8 (n=41, 41, 40, 40, 39, LOCF) -1.0  (2.3) -1.1  (2.1) -0.9  (1.4) -2.0  (2.1) -0.9  (1.8)
5.Secondary Outcome
Title Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline
Hide Description

TBUT is the interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. Using a stopwatch, the time between last complete blink and first appearance of dry spot was recorded.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change: value at observation minus value at baseline. Positive change from baseline indicated improvement.

Time Frame Baseline, Week 1, 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 41 42 41 40 39
Mean (Standard Deviation)
Unit of Measure: Seconds
Week 1 (n=41, 41, 40, 40, 39) 0.04  (0.83) 0.43  (3.61) 0.19  (0.76) 0.22  (1.95) 0.43  (3.22)
Week 2 (n=40, 41, 39, 40, 39) 0.09  (0.95) -0.31  (2.84) 0.26  (0.84) 0.04  (1.54) 1.72  (8.53)
Week 4 (n=41, 40, 35, 40, 38) -0.01  (0.92) 0.20  (3.61) 0.31  (0.62) 0.46  (1.87) 0.53  (1.42)
Week 8 (n=41, 41, 40, 40, 39, LOCF) -0.06  (1.13) -0.25  (2.17) 0.27  (0.77) 1.00  (3.56) 0.76  (1.38)
6.Secondary Outcome
Title Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline
Hide Description

The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change: value at observation minus value at baseline. Positive change from baseline indicated improvement.

Time Frame Baseline, Week 1, 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 41 42 41 40 39
Mean (Standard Deviation)
Unit of Measure: Millimeters
Week 1 (n=41, 41, 40, 40, 39) 0.78  (6.07) 0.34  (3.10) 0.01  (2.16) 0.08  (3.01) 0.71  (3.99)
Week 2 (n=40, 41, 39, 40, 39) 0.28  (2.77) 0.51  (3.49) 0.28  (2.26) 0.93  (3.56) 1.04  (4.53)
Week 4 (n=41, 40, 35, 40, 38) 0.30  (3.39) 0.49  (2.54) 0.13  (2.28) 1.13  (4.23) 0.64  (3.38)
Week 8 (n=41, 41, 40, 40, 39, LOCF) 0.91  (5.43) 0.10  (2.57) 0.74  (2.46) 0.26  (2.93) 1.53  (5.32)
7.Secondary Outcome
Title Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye
Hide Description

The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Time Frame Week 1, 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data at Week 8.
Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 41 42 41 40 39
Measure Type: Number
Unit of Measure: Percentage of participants
Week 1 (n=41, 41, 40, 40, 39) 7.3 4.9 0 2.5 7.7
Week 2 (n=40, 41, 39, 40, 39) 2.5 4.9 2.6 7.5 10.3
Week 4 (n=41, 40, 35, 40, 38) 7.3 5.0 2.9 7.5 5.3
Week 8 (n=41, 41, 40, 40, 39, LOCF) 9.8 4.9 2.5 5.0 12.8
8.Secondary Outcome
Title Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye
Hide Description

The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Time Frame Week 1, 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 41 42 41 40 39
Measure Type: Number
Unit of Measure: Participants
Week 1 (n=41, 41, 40, 40, 39) 2 1 0 1 1
Week 2 (n=40, 41, 39, 40, 39) 0 1 0 2 2
Week 4 (n=41, 40, 35, 40, 38) 1 0 0 2 1
Week 8 (n=41, 41, 40, 40, 39, LOCF) 3 0 0 1 3
9.Secondary Outcome
Title Changes in the Ocular Comfort Index (OCI) Total Score From Baseline
Hide Description

The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.

Time Frame Baseline, Week 1, 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 41 42 41 40 39
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 (n=41, 41, 40, 40, 39) -1.94  (5.20) -2.00  (6.22) -2.13  (7.92) -4.17  (6.86) -3.14  (7.88)
Week 2 (n=40, 41, 40, 40, 39) -4.16  (9.00) -4.76  (7.63) -3.80  (8.77) -5.88  (6.98) -3.40  (6.12)
Week 4 (n=41, 40, 35, 40, 38) -3.27  (6.95) -4.20  (7.08) -5.77  (9.71) -5.74  (7.26) -3.58  (9.85)
Week 8 (n=41, 41, 40, 40, 39, LOCF) -5.09  (7.74) -4.98  (7.67) -3.90  (9.30) -6.87  (8.59) -4.22  (9.53)
10.Secondary Outcome
Title Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline
Hide Description

The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement.

Time Frame Week 1, 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 41 42 41 40 39
Measure Type: Number
Unit of Measure: Participants
Week 1 (n=41, 41, 40, 40, 39) 17 15 13 21 16
Week 2 (n=40, 41, 40, 40, 39) 19 21 19 28 20
Week 4 (n=41, 40, 35, 40, 38) 23 23 21 26 16
Week 8 (n=41, 41, 40, 40, 39, LOCF) 25 26 22 26 16
11.Secondary Outcome
Title Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline
Hide Description

The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.

The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The total OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) × 100]/[(total number of questions answered) × 4].

The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.

Time Frame Baseline, Week 1, 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 41 42 41 40 39
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 (n=41, 41, 40, 40, 39) -0.43  (12.33) -3.87  (12.42) -0.67  (12.68) -5.00  (9.13) -2.99  (10.27)
Week 2 (n=40, 41, 40, 40, 39) -4.09  (13.73) -7.04  (12.98) -3.13  (14.45) -6.77  (11.28) -2.89  (11.34)
Week 4 (n=41, 40, 35, 40, 38) -3.18  (13.77) -5.99  (15.78) -4.48  (13.92) -5.11  (14.03) -2.56  (12.69)
Week 8 (n=41, 41, 40, 40, 39, LOCF) -3.88  (14.92) -7.07  (17.88) -0.37  (16.77) -5.89  (14.98) -2.68  (15.10)
12.Secondary Outcome
Title Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms
Hide Description

The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.

The 12 items of the OSDI questionnaire were graded on a scale of 0 [the none of time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 1 to 3 answered) × 100]/[(total number of questions 1 to 3 answered) × 4].

The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.

Time Frame Baseline, Week 1, 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 41 42 41 40 39
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 (n=41, 41, 40, 40, 39) -0.81  (15.90) -4.07  (13.83) -3.96  (13.74) -5.00  (12.77) -2.56  (14.70)
Week 2 (n=40, 41, 40, 40, 39) -4.17  (19.61) -8.74  (18.06) -3.75  (14.24) -7.92  (16.01) -3.63  (13.49)
Week 4 (n=41, 40, 35, 40, 38) -3.05  (18.89) -7.50  (19.59) -6.19  (14.05) -5.42  (17.56) -1.97  (15.43)
Week 8 (n=41, 41, 40, 40, 39, LOCF) -3.86  (19.01) -7.72  (21.20) -2.29  (17.29) -6.04  (18.87) -0.21  (15.59)
13.Secondary Outcome
Title Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function
Hide Description

The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.

The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 4 to 9 answered) × 100]/[(total number of questions 4 to 9 answered) × 4].

Thus, the OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.

Time Frame Baseline, Week 1, 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 41 42 41 40 39
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 (n=41, 41, 40, 40, 39) -0.36  (18.75) -4.71  (14.31) 0.40  (17.35) -6.55  (12.20) -3.33  (13.41)
Week 2 (n=40, 41, 40, 40, 39) -2.61  (16.88) -5.83  (15.52) -2.29  (20.91) -7.06  (11.87) -2.57  (14.48)
Week 4 (n=41, 40, 35, 40, 38) -1.70  (16.73) -6.52  (15.25) -4.74  (17.82) -4.29  (14.04) -2.69  (15.35)
Week 8 (n=41, 41, 40, 40, 39, LOCF) -2.56  (19.45) -8.29  (16.61) -2.07  (18.71) -4.75  (12.49) -3.81  (17.46)
14.Secondary Outcome
Title Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers
Hide Description

The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.

The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 10 to 12 answered) × 100]/[(total number of questions 10 to 12 answered) × 4].

The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.

Time Frame Baseline, Week 1, 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 41 42 41 40 39
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 (n=38, 37, 40, 39, 35) 1.21  (22.11) -4.28  (23.66) 0.31  (22.20) -3.53  (15.52) -4.88  (20.32)
Week 2 (n=37, 37, 39, 37, 37) -6.53  (20.43) -7.21  (25.43) -6.20  (22.25) -8.56  (18.66) -4.28  (21.48)
Week 4 (n=38, 37, 35, 37, 36) -6.14  (23.72) -3.15  (30.23) -2.14  (24.88) -9.57  (22.78) -4.17  (23.44)
Week 8 (n=38, 37, 40, 39, 38, LOCF) -7.13  (22.92) -4.05  (34.11) 3.02  (31.76) -8.44  (27.83) -4.82  (24.46)
15.Secondary Outcome
Title Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline
Hide Description

The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.

The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The total OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) × 100]/[(total number of questions answered) × 4].

The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Time Frame Week 1, 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 41 42 41 40 39
Measure Type: Number
Unit of Measure: Percentage of participants
Week 1 (n=41, 41, 40, 40, 39) 14.6 24.4 12.5 22.5 20.5
Week 2 (n=40, 41, 40, 40, 39) 32.5 34.1 27.5 25.0 20.5
Week 4 (n=41, 40, 35, 40, 38) 34.1 37.5 25.7 35.0 18.4
Week 8 (n=41, 41, 40, 40, 39, LOCF) 34.1 41.5 22.5 35.0 20.5
16.Secondary Outcome
Title Number of Participants Evaluable for Time to Achievement of 100% Clearing of Corneal Staining for Study Eye
Hide Description

Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale. The maximum possible staining score is 15, higher score indicated greater staining.

100% Clearing of Corneal Staining means corneal staining score = 0. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: Participants who received at least 1 dose of study treatment.
Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 41 42 41 40 39
Measure Type: Number
Unit of Measure: Participants
8 4 6 5 1
17.Secondary Outcome
Title Number of Participants Evaluable for Time to Achievement of ≥10 mm Schirmer Wetting Score Without Anesthesia for Study Eye
Hide Description

The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: Participants who received at least 1 dose of study treatment.
Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 41 42 41 40 39
Measure Type: Number
Unit of Measure: Participants
8 6 2 4 7
18.Secondary Outcome
Title Number of Participants Evaluable for Time to Achievement of ≥3 Unit Decrease in OCI Scores
Hide Description The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Negative change from baseline indicated improvement. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: Participants who received at least 1 dose of study treatment.
Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 41 42 41 40 39
Measure Type: Number
Unit of Measure: Participants
31 29 30 35 28
19.Secondary Outcome
Title Number of Participants With Ocular Adverse Events (AEs)by Severity
Hide Description Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Ocular AEs are the events which are localized in the ocular region. Participants with multiple occurrences of an AE within a category were counted once within the category.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: Participants who received at least 1 dose of study treatment.
Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan CP-690,550 Eye Drops Vehicle Group in Korea CP-690,550 Eye Drops 0.001% Group in Korea CP-690,550 Eye Drops 0.003% Group in Korea CP-690,550 Eye Drops 0.005% Group in Korea
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
Overall Number of Participants Analyzed 41 42 41 40 39 21 19 21 21
Measure Type: Number
Unit of Measure: Participants
Mild 4 0 4 2 2 3 7 0 6
Moderate 0 0 1 0 0 2 3 6 4
Severe 0 1 2 0 0 0 0 2 0
20.Secondary Outcome
Title Number of Participants With Nonocular Adverse Events (AEs) by Severity
Hide Description Counts of participants who had treatment-emergent nonocular AEs, defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: Participants who received at least 1 dose of study treatment.
Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan CP-690,550 Eye Drops Vehicle Group in Korea CP-690,550 Eye Drops 0.001% Group in Korea CP-690,550 Eye Drops 0.003% Group in Korea CP-690,550 Eye Drops 0.005% Group in Korea
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
Overall Number of Participants Analyzed 41 42 41 40 39 21 19 21 21
Measure Type: Number
Unit of Measure: Participants
Mild 7 12 10 10 8 2 1 5 4
Moderate 1 0 2 0 0 3 1 4 2
Severe 0 0 2 0 0 0 0 0 0
21.Secondary Outcome
Title Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale
Hide Description

Ocular tolerability was assessed for the 5 symptoms (burning sensation, blurred vision, ocular discomfort, pain, tearing), based on a 4-point severity scale (none, minor, moderate, and severe).

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: Participants who received at least 1 dose of study treatment.
Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan CP-690,550 Eye Drops Vehicle Group in Korea CP-690,550 Eye Drops 0.001% Group in Korea CP-690,550 Eye Drops 0.003% Group in Korea CP-690,550 Eye Drops 0.005% Group in Korea
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
Overall Number of Participants Analyzed 41 42 41 40 39 21 19 21 21
Measure Type: Number
Unit of Measure: Participants
None for blurring of vision 32 33 32 32 36 11 11 15 13
Minor for blurring of vision 9 8 7 8 3 9 6 5 7
Moderate for blurring of vision 0 1 2 0 0 1 2 1 1
Severe for blurring of vision 0 0 0 0 0 0 0 0 0
None for burning sensation 26 22 26 27 34 7 7 11 9
Minor for burning sensation 15 19 14 12 4 10 10 9 10
Moderate for burning sensation 0 0 1 1 0 3 2 1 2
Severe for burning sensation 0 1 0 0 1 1 0 0 0
None for ocular discomfort 30 29 30 31 29 6 4 7 6
Minor for ocular discomfort 10 12 9 8 8 8 11 6 8
Moderate for ocular discomfort 1 1 2 1 1 6 3 7 6
Severe for ocular discomfort 0 0 0 0 1 1 1 1 1
None for pain 28 30 34 32 34 12 9 12 9
Minor for pain 13 11 6 7 3 4 10 7 9
Moderate for pain 0 0 1 1 2 4 0 2 3
Severe for pain 0 1 0 0 0 1 0 0 0
None for tearing 40 38 39 37 36 15 15 18 19
Minor for tearing 1 3 2 3 3 6 4 3 2
Moderate for tearing 0 1 0 0 0 0 0 0 0
Severe for tearing 0 0 0 0 0 0 0 0 0
22.Other Pre-specified Outcome
Title Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Human Leukocyte Antigen-DR Antibody Bound Per Cell for Study Eye
Hide Description

The average level of HLA-DR expression per cell was reported as HLA-DR antibody bound per cell (ABC).

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change = value at observation minus value at baseline.

Time Frame Baseline, Week 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of intent-to-treat population collected impression cytology samples from both eyes at screening, week 4 and week 8.
Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 8 5 10 12 13
Mean (Standard Deviation)
Unit of Measure: Antibodies bound per cell
Week 4 (n=7, 4, 9, 12, 8) 1570.4  (8698.5) -13899.5  (13383.8) 5394.3  (10641.9) 1573.8  (10087.5) -1908.6  (11259.4)
Week 8 (n=6, 4, 6, 11, 10) -1496.5  (10426.5) -8326.3  (11164.6) 56.0  (5308.4) 3431.9  (16532.5) 1148.5  (12129.6)
23.Other Pre-specified Outcome
Title Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Percentage of Human Leukocyte Antigen (HLA)-DR Positive for Study Eye
Hide Description

Percentage of conjunctival epithelial cells that were positive with HLA-DR expression was calculated as HLA-DR Positive.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Time Frame Baseline, Week 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of intent-to-treat population collected impression cytology samples from both eyes at screening, week 4 and week 8.
Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 8 5 10 12 13
Mean (Standard Deviation)
Unit of Measure: Percentage of positive cells
Week 4 (n=7, 4, 9, 12, 8) -10.27  (20.73) -0.87  (18.24) 11.51  (18.74) -6.83  (28.64) 18.30  (30.40)
Week 8 (n=6, 4, 6, 11, 10) -6.77  (18.19) 6.65  (25.65) 5.17  (24.73) -1.05  (35.75) 11.74  (24.84)
24.Other Pre-specified Outcome
Title Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Apolipoprotein C-3
Hide Description

Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change= value at visit minus value at baseline.

Time Frame Baseline, Week 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description

A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.

n=number of analyzed with sufficient quantity for testing.

Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 17 14 9 8 11
Mean (Standard Deviation)
Unit of Measure: ng/mL
Week 4 (n=4, 5, 2, 4, 3) -30.675  (78.363) -38.540  (93.153) -153.500  (164.756) -6384.063  (12606.637) 58.500  (59.729)
Week 8 (n=4, 6, 2, 5, 3) -39.250  (786.061) -5.167  (33.983) -70.800  (16.688) -5102.010  (11352.752) -1.300  (1.752)
25.Other Pre-specified Outcome
Title Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-18
Hide Description

Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change= value at visit minus value at baseline.

Time Frame Baseline, Week 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description

A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.

n=number of analyzed with sufficient quantity for testing.

Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 17 14 9 8 11
Mean (Standard Deviation)
Unit of Measure: pg/mL
Week 4 (n=4, 5, 2, 4, 3) 247.5  (374.7) -73.0  (57.6) 146.0  (206.5) -154.6  (287.3) 22.5  (57.1)
Week 8 (n=4, 6, 2, 5, 3) -81.3  (110.7) -6.0  (186.1) 100.0  (43.8) 18.0  (210.9) 51.2  (27.0)
26.Other Pre-specified Outcome
Title Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-6
Hide Description

Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change= value at visit minus value at baseline.

Time Frame Baseline, Week 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description

A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.

n=number of analyzed with sufficient quantity for testing.

Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 17 14 9 8 11
Mean (Standard Deviation)
Unit of Measure: pg/mL
Week 4 (n=4, 5, 2, 4, 3) 76.00  (140.92) -36.80  (48.75) 22.50  (21.92) -19.70  (126.34) 16.33  (34.70)
Week 8 (n=4, 6, 2, 5, 3) -11.00  (23.35) 4.00  (25.49) 139.00  (192.33) 25.80  (141.39) 12.00  (14.00)
27.Other Pre-specified Outcome
Title Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-7
Hide Description

Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change= value at visit minus value at baseline.

Time Frame Baseline, Week 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description

A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.

n=number of analyzed with sufficient quantity for testing.

Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 17 14 9 8 11
Mean (Standard Deviation)
Unit of Measure: pg/mL
Week 4 (n=4, 5, 2, 4, 3) 35.8  (51.6) -6.8  (38.8) 28.0  (22.6) 3.5  (73.6) 10.0  (50.7)
Week 8 (n=4, 6, 2, 5, 3) 14.3  (16.7) 19.5  (30.9) -15.0  (8.5) -16.4  (28.6) 25.0  (16.5)
28.Other Pre-specified Outcome
Title Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-8
Hide Description

Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change= value at visit minus value at baseline.

Time Frame Baseline, Week 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description

A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.

n=number of analyzed with sufficient quantity for testing.

Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 17 14 9 8 11
Mean (Standard Deviation)
Unit of Measure: pg/mL
Week 4 (n=4, 5, 2, 4, 3) 365.0  (348.2) -18.8  (739.1) -7.0  (470.9) -1057.3  (1954.2) 564.3  (1171.8)
Week 8 (n=4, 6, 2, 5, 3) -2486.3  (4656.3) -367.8  (961.9) -112.5  (484.4) -471.6  (2378.4) 305.7  (361.9)
29.Other Pre-specified Outcome
Title Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Monocyte Chemotactic Protein 1
Hide Description

Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change= value at visit minus value at baseline.

Time Frame Baseline, Week 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description

A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.

n=number of analyzed with sufficient quantity for testing.

Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 17 14 9 8 11
Mean (Standard Deviation)
Unit of Measure: pg/mL
Week 4 (n=4, 5, 2, 4, 3) -168.5  (265.3) -438.8  (962.4) 24.5  (79.9) -468.0  (390.6) 26.7  (63.1)
Week 8 (n=4, 6, 2, 5, 3) -179.3  (144.1) -289.7  (1205.3) -169.5  (217.1) 28.2  (431.0) -14.3  (33.9)
30.Other Pre-specified Outcome
Title Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-12 P40/P35 Heterodimer (IL-12P70)
Hide Description

Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change= value at visit minus value at baseline.

Time Frame Baseline, Week 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description

A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.

n=number of analyzed with sufficient quantity for testing.

Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 17 14 9 8 11
Mean (Standard Deviation)
Unit of Measure: pg/mL
Week 4 (n=4, 5, 2, 4, 3) -5.0  (16.1) -5.4  (17.0) 27.0  (14.1) -17.0  (24.9) 3.7  (22.7)
Week 8 (n=4, 6, 2, 5, 3) 17.5  (21.7) 15.8  (57.9) 0.0  (0.0) 1.6  (38.4) 31.7  (23.6)
31.Other Pre-specified Outcome
Title Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Beta
Hide Description

Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change= value at visit minus value at baseline.

Time Frame Baseline, Week 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description

A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.

n=number of analyzed with sufficient quantity for testing.

Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 17 14 9 8 11
Mean (Standard Deviation)
Unit of Measure: pg/mL
Week 4 (n=4, 5, 2, 4, 3) -0.05  (1.60) -1.42  (5.22) 2.75  (0.35) -4.93  (10.29) 6.03  (8.54)
Week 8 (n=4, 6, 2, 5, 3) -0.70  (4.97) -0.42  (5.84) 6.00  (8.49) -2.14  (7.88) 2.03  (0.15)
32.Other Pre-specified Outcome
Title Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Receptor Antagonist
Hide Description

Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change= value at visit minus value at baseline.

Time Frame Baseline, Week 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description

A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.

n=number of analyzed with sufficient quantity for testing.

Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 17 14 9 8 11
Mean (Standard Deviation)
Unit of Measure: pg/mL
Week 4 (n=3, 5, 2, 4, 3) 76500.0  (363953.6) -172800.0  (256165.4) 269500.0  (498510.3) -370575.0  (647507.1) 15600.0  (156124.6)
Week 8 (n=4, 6, 2, 5, 2) -256000.0  (451986.0) 153833.3  (317150.7) 200000.0  (144249.8) -268260.0  (546901.3) 397550.0  (621476.1)
33.Other Pre-specified Outcome
Title Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-23
Hide Description

Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change= value at visit minus value at baseline.

Time Frame Baseline, Week 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description

A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.

n=number of analyzed with sufficient quantity for testing.

Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 17 14 9 8 11
Mean (Standard Deviation)
Unit of Measure: ng/mL
Week 4 (n=4, 5, 2, 4, 3) 3.15  (6.14) -13.80  (22.14) 8.00  (21.21) -7.13  (19.21) 2.73  (3.04)
Week 8 (n=4, 6, 2, 5, 3) -6.78  (18.62) 3.60  (16.65) -4.00  (9.90) 0.60  (6.02) 0.00  (0.00)
34.Other Pre-specified Outcome
Title Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-3
Hide Description

Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change= value at visit minus value at baseline.

Time Frame Baseline, Week 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description

A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.

n=number of analyzed with sufficient quantity for testing.

Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 17 14 9 8 11
Mean (Standard Deviation)
Unit of Measure: ng/mL
Week 4 (n=4, 5, 2, 4, 3) 2.675  (5.952) -1.948  (3.682) -0.470  (1.598) -24.833  (48.019) 0.957  (1.202)
Week 8 (n=4, 6, 2, 5, 3) 21.205  (42.696) -0.517  (3.527) -0.650  (0.919) -14.476  (31.070) 0.203  (0.313)
35.Other Pre-specified Outcome
Title Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-9
Hide Description

Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change= value at visit minus value at baseline.

Time Frame Baseline, Week 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description

A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.

n=number of analyzed with sufficient quantity for testing.

Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 17 14 9 8 11
Mean (Standard Deviation)
Unit of Measure: ng/mL
Week 4 (n=4, 5, 2, 4, 3) 22.3  (35.8) -13.2  (29.5) 8.5  (12.0) -88.3  (120.8) 35.0  (60.6)
Week 8 (n=4, 6, 2, 5, 3) 0.0  (0.0) 57.0  (90.1) 37.5  (53.0) -41.2  (46.7) 26.7  (69.0)
36.Other Pre-specified Outcome
Title Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Vascular Endothelial Growth Factor
Hide Description

Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change= value at visit minus value at baseline.

Time Frame Baseline, Week 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description

A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.

n=number of analyzed with sufficient quantity for testing.

Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 17 14 9 8 11
Mean (Standard Deviation)
Unit of Measure: pg/mL
Week 4 (n=4, 5, 2, 4, 3) 152.5  (1620.5) -942.0  (2466.2) 840.0  (735.4) -1486.5  (4486.5) 546.7  (546.4)
Week 8 (n=4, 6, 2, 5, 3) -1812.5  (1477.6) 790.0  (1639.2) -910.0  (2588.0) 734.0  (3267.6) -699.3  (1094.8)
37.Other Pre-specified Outcome
Title Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Alpha-1 Antitrypsin
Hide Description

Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change= value at visit minus value at baseline.

Time Frame Baseline, Week 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description

A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.

n=number of analyzed with sufficient quantity for testing.

Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 17 14 9 8 11
Mean (Standard Deviation)
Unit of Measure: ng/mL
Week 4 (n=4, 5, 2, 4, 3) -1115.0  (3226.2) -4054.0  (8558.2) 1535.0  (2170.8) -628.5  (5314.7) 5400.0  (3104.5)
Week 8 (n=4, 6, 2, 5, 3) -2902.5  (4534.4) 505.0  (2977.2) -1375.0  (1944.5) 1220.8  (4111.8) 2246.7  (2329.9)
38.Other Pre-specified Outcome
Title Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-17A
Hide Description

Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change= value at visit minus value at baseline.

Time Frame Baseline, Week 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description

A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.

n=number of analyzed with sufficient quantity for testing.

Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 17 14 9 8 11
Mean (Standard Deviation)
Unit of Measure: pg/mL
Week 4 (n=4, 5, 2, 4, 3) 1.98  (5.47) -2.08  (4.28) 1.95  (2.76) -4.30  (9.40) 1.60  (1.44)
Week 8 (n=4, 6, 2, 5, 3) -1.18  (1.39) 0.88  (4.75) 0.00  (0.00) -3.58  (8.01) 3.93  (4.61)
39.Other Pre-specified Outcome
Title Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 10 (CXCL10) (Alias Gamma-Interferon Inducible Protein 10: IP10)
Hide Description

Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change= value at visit minus value at baseline.

Time Frame Baseline, Week 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description

A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.

n=number of analyzed with sufficient quantity for testing.

Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 17 14 9 8 11
Mean (Standard Deviation)
Unit of Measure: pg/mL
Week 4 (n=3, 5, 2, 4, 3) -1196.7  (3885.1) -7224.0  (27315.6) 14545.0  (24967.9) -11622.5  (28687.6) 15103.3  (56584.3)
Week 8 (n=4, 6, 2, 5, 2) -13440.0  (27749.2) 18971.7  (30883.3) -6230.0  (7028.6) 6306.0  (24845.5) -9690.0  (13732.0)
40.Other Pre-specified Outcome
Title Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 9 (CXCL9) (Alias Monokine Induced by Gamma Interferon: MIG)
Hide Description

Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change= value at visit minus value at baseline.

Time Frame Baseline, Week 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description

A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.

n=number of analyzed with sufficient quantity for testing.

Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 17 14 9 8 11
Mean (Standard Deviation)
Unit of Measure: pg/mL
Week 4 (n=3, 4, 2, 4, 3) -633.3  (1325.5) -47485.0  (110811.6) 21025.0  (45078.1) -18020.0  (44942.7) 14003.3  (22925.3)
Week 8 (n=4, 5, 2, 5, 2) -34722.5  (62344.4) 3118.0  (23681.2) -10150.0  (2899.1) 22148.0  (36704.1) -4220.0  (5741.7)
41.Other Pre-specified Outcome
Title Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine ( C-C Motif) Ligand 20 (CCL20) (Alias Macrophage Inflammatory Protein 3 Alpha: MIP3A)
Hide Description

Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change= value at visit minus value at baseline.

Time Frame Baseline, Week 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description

A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.

n=number of analyzed with sufficient quantity for testing.

Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 17 14 9 8 11
Mean (Standard Deviation)
Unit of Measure: pg/mL
Week 4 (n=4, 5, 2, 4, 3) 1.3  (541.7) 47.4  (281.2) 630.0  (325.3) -1562.5  (2787.4) -301.3  (1138.3)
Week 8 (n=4, 6, 2, 5, 3) -1237.8  (1975.3) 534.5  (868.9) -360.0  (1004.1) -327.6  (2083.1) 246.7  (331.6)
42.Other Pre-specified Outcome
Title Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-C Motif) Ligand 5 (CCL5) (Alias Regulated on Activation, Normal T Cell Expressed, and Secreted: RANTES)
Hide Description

Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change= value at visit minus value at baseline.

Time Frame Baseline, Week 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description

A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.

n=number of analyzed with sufficient quantity for testing.

Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 17 14 9 8 11
Mean (Standard Deviation)
Unit of Measure: pg/mL
Week 4 (n=4, 5, 2, 4, 3) 13.25  (31.28) -12.06  (70.14) 21.50  (40.31) -28.98  (57.50) 19.43  (51.60)
Week 8 (n=4, 6, 2, 5, 3) -61.48  (79.46) -3.83  (81.17) 6.50  (36.06) -9.58  (49.45) -8.93  (15.77)
43.Other Pre-specified Outcome
Title Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Tissue Inhibitor of Metalloproteinase 1 (TIMP-1)
Hide Description

Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change= value at visit minus value at baseline.

Time Frame Baseline, Week 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description

A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.

n=number of analyzed with sufficient quantity for testing.

Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 17 14 9 8 11
Mean (Standard Deviation)
Unit of Measure: ng/mL
Week 4 (n=4, 5, 2, 4, 3) 12.5  (85.9) -19.8  (73.5) 124.5  (173.2) -131.8  (165.9) 142.3  (375.9)
Week 8 (n=4, 6, 2, 5, 3) -48.5  (69.8) 34.3  (75.2) -109.0  (168.3) -76.8  (88.1) 114.0  (167.7)
44.Other Pre-specified Outcome
Title Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Epidermal Growth Factor
Hide Description

Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change= value at visit minus value at baseline.

Time Frame Baseline, Week 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description

A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.

n=number of analyzed with sufficient quantity for testing.

Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 17 14 9 8 11
Mean (Standard Deviation)
Unit of Measure: pg/mL
Week 4 (n=4, 5, 2, 4, 3) -0.5  (495.3) -213.2  (1803.5) -138.5  (186.0) 0.5  (3816.2) -121.7  (1815.2)
Week 8 (n=4, 6, 2, 5, 3) -15.5  (370.2) 361.0  (857.7) -885.0  (1322.3) -122.0  (1612.5) -212.7  (532.5)
45.Other Pre-specified Outcome
Title Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Albumin
Hide Description

Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change= value at visit minus value at baseline.

Time Frame Baseline, Week 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description

A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.

n=number of analyzed with sufficient quantity for testing.

Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 17 14 9 8 11
Mean (Standard Deviation)
Unit of Measure: mcg/mL
Week 4 (n=4, 5, 2, 4, 3) -228.00  (409.55) -28.20  (94.15) 42.50  (181.73) 111.75  (293.07) 164.67  (73.04)
Week 8 (n=4, 6, 2, 5, 3) 99.50  (354.15) 125.17  (292.09) 1.00  (147.08) 96.00  (141.26) 81.33  (75.63)
46.Other Pre-specified Outcome
Title Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 5AC
Hide Description

Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change= value at visit minus value at baseline.

Time Frame Baseline, Week 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description

A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.

n=number of analyzed with sufficient quantity for testing.

Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 17 14 9 8 11
Mean (Standard Deviation)
Unit of Measure: Relative unit/mL
Week 4 (n=3, 5, 2, 4, 3) 1704.00  (4222.07) -871.40  (4857.15) 383.00  (24.04) -35221.50  (67264.76) 1651.67  (7544.36)
Week 8 (n=4, 6, 2, 5, 3) -18222.00  (32490.62) 487.83  (5164.47) 6926.00  (10004.15) -35105.40  (84919.27) -1698.33  (2346.05)
47.Other Pre-specified Outcome
Title Number of Participants Evaluated for Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 4
Hide Description

Number of analyzed with sufficient quantity for analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Time Frame Week 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.
Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 17 14 9 8 11
Measure Type: Number
Unit of Measure: Participants
Week 4 2 2 1 1 1
Week 8 0 2 1 1 1
48.Other Pre-specified Outcome
Title Change in the Biomarker in Tear Fluid for Study Eye From Baseline - Mucin 16 Carbohydrate Antigen 125
Hide Description

Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change= value at visit minus value at baseline.

Time Frame Baseline, Week 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description

A subset of Intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.

n=number of analyzed with sufficient quantity for testing.

Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 17 14 9 8 11
Mean (Standard Deviation)
Unit of Measure: Relative unit/mL
Week 4 (n=4, 5, 2, 4, 3) 44.8  (337.3) -228.6  (1493.7) -41.0  (312.5) -648.5  (1710.9) 130.0  (178.0)
Week 8 (n=4, 6, 2, 5, 3) -487.3  (364.0) 4.0  (910.5) 265.5  (685.2) -427.6  (1479.9) -289.3  (86.8)
49.Other Pre-specified Outcome
Title Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 1
Hide Description

Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change= value at visit minus value at baseline.

Time Frame Baseline, Week 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description

A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.

n=number of analyzed with sufficient quantity for testing.

Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 17 14 9 8 11
Mean (Standard Deviation)
Unit of Measure: Relative unit/mL
Week 4 (n=4, 5, 2, 4, 3) 41.0  (35.6) 194.8  (428.5) 79.5  (89.8) -328.5  (634.9) -5.3  (23.5)
Week 8 (n=4, 6, 2, 5, 3) -97.0  (183.0) 33.5  (124.2) 30.5  (57.3) -80.2  (200.1) -15.3  (23.2)
50.Other Pre-specified Outcome
Title Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Lipocalin 1
Hide Description

Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change= value at visit minus value at baseline.

Time Frame Baseline, Week 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description

A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.

n=number of analyzed with sufficient quantity for testing.

Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 17 14 9 8 11
Mean (Standard Deviation)
Unit of Measure: mcg/mL
Week 4 (n=4, 5, 2, 4, 3) -17.00  (2539.88) 257.00  (382.18) -3115.50  (4418.71) -651.00  (659.50) 573.00  (8434.01)
Week 8 (n=4, 6, 2, 5, 3) -1524.50  (2083.82) 588.67  (1504.14) -3560.00  (5048.74) 222.60  (1420.46) -417.00  (4540.91)
51.Other Pre-specified Outcome
Title Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Total Protein
Hide Description

Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.

Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Change= value at visit minus value at baseline.

Time Frame Baseline, Week 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description

A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.

n=number of analyzed with sufficient quantity for testing.

Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Hide Arm/Group Description:
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
Overall Number of Participants Analyzed 17 14 9 8 11
Mean (Standard Deviation)
Unit of Measure: mcg/mL
Week 4 (n=4, 5, 2, 4, 3) 748.8  (4116.3) -956.0  (4190.6) 1180.0  (311.1) -8281.3  (13425.6) 6328.3  (17461.8)
Week 8 (n=4, 6, 2, 5, 3) -2322.5  (4827.1) 836.7  (4104.5) -5695.0  (8605.5) -3070.0  (4798.4) 5195.0  (9724.4)
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan CP-690,550 Eye Drops Vehicle Group in Korea CP-690,550 Eye Drops 0.001% Group in Korea CP-690,550 Eye Drops 0.003% Group in Korea CP-690,550 Eye Drops 0.005% Group in Korea
Hide Arm/Group Description At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks. At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period. At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
All-Cause Mortality
CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan CP-690,550 Eye Drops Vehicle Group in Korea CP-690,550 Eye Drops 0.001% Group in Korea CP-690,550 Eye Drops 0.003% Group in Korea CP-690,550 Eye Drops 0.005% Group in Korea
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan CP-690,550 Eye Drops Vehicle Group in Korea CP-690,550 Eye Drops 0.001% Group in Korea CP-690,550 Eye Drops 0.003% Group in Korea CP-690,550 Eye Drops 0.005% Group in Korea
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)   0/42 (0.00%)   2/41 (4.88%)   0/40 (0.00%)   0/39 (0.00%)   0/21 (0.00%)   0/19 (0.00%)   1/21 (4.76%)   0/21 (0.00%) 
Gastrointestinal disorders                   
Gastric ulcer  1  0/41 (0.00%)  0/42 (0.00%)  1/41 (2.44%)  0/40 (0.00%)  0/39 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/21 (0.00%)  0/21 (0.00%) 
Infections and infestations                   
Bronchiectasis  1  0/41 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  1/21 (4.76%)  0/21 (0.00%) 
Injury, poisoning and procedural complications                   
Foot fracture  1  0/41 (0.00%)  0/42 (0.00%)  1/41 (2.44%)  0/40 (0.00%)  0/39 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/21 (0.00%)  0/21 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CP-690,550 Eye Drops Vehicle Group in Japan CP-690,550 Eye Drops 0.001% Group in Japan CP-690,550 Eye Drops 0.003% Group in Japan CP-690,550 Eye Drops 0.005% Group in Japan Sodium Hyaluronate Eye Drops 0.1% Group in Japan CP-690,550 Eye Drops Vehicle Group in Korea CP-690,550 Eye Drops 0.001% Group in Korea CP-690,550 Eye Drops 0.003% Group in Korea CP-690,550 Eye Drops 0.005% Group in Korea
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/41 (26.83%)   11/42 (26.19%)   16/41 (39.02%)   8/40 (20.00%)   9/39 (23.08%)   6/21 (28.57%)   7/19 (36.84%)   6/21 (28.57%)   8/21 (38.10%) 
Blood and lymphatic system disorders                   
Anaemia  1  0/41 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  1/21 (4.76%)  0/19 (0.00%)  0/21 (0.00%)  0/21 (0.00%) 
Leukopenia  1  0/41 (0.00%)  1/42 (2.38%)  0/41 (0.00%)  1/40 (2.50%)  0/39 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/21 (0.00%)  0/21 (0.00%) 
Neutropenia  1  0/41 (0.00%)  1/42 (2.38%)  0/41 (0.00%)  1/40 (2.50%)  0/39 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/21 (0.00%)  0/21 (0.00%) 
Eye disorders                   
Conjunctival erosion  1  0/41 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  1/21 (4.76%)  1/21 (4.76%) 
Conjunctival haemorrhage  1  1/41 (2.44%)  0/42 (0.00%)  0/41 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/21 (0.00%)  1/19 (5.26%)  0/21 (0.00%)  0/21 (0.00%) 
Conjunctival hyperaemia  1  1/41 (2.44%)  0/42 (0.00%)  0/41 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/21 (0.00%)  0/21 (0.00%) 
Conjunctival oedema  1  0/41 (0.00%)  0/42 (0.00%)  1/41 (2.44%)  0/40 (0.00%)  0/39 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/21 (0.00%)  0/21 (0.00%) 
Conjunctivitis  1  0/41 (0.00%)  0/42 (0.00%)  1/41 (2.44%)  0/40 (0.00%)  0/39 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/21 (0.00%)  0/21 (0.00%) 
Dry eye  1  1/41 (2.44%)  0/42 (0.00%)  0/41 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/21 (0.00%)  0/21 (0.00%) 
Eye discharge  1  0/41 (0.00%)  0/42 (0.00%)  1/41 (2.44%)  1/40 (2.50%)  0/39 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/21 (0.00%)  0/21 (0.00%) 
Eye irritation  1  0/41 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  3/21 (14.29%)  3/19 (15.79%)  2/21 (9.52%)  2/21 (9.52%) 
Eye pain  1  0/41 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/40 (0.00%)  1/39 (2.56%)  0/21 (0.00%)  1/19 (5.26%)  1/21 (4.76%)  1/21 (4.76%) 
Keratitis  1  1/41 (2.44%)  0/42 (0.00%)  1/41 (2.44%)  0/40 (0.00%)  0/39 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  2/21 (9.52%)  0/21 (0.00%) 
Keratopathy  1  0/41 (0.00%)  1/42 (2.38%)  0/41 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/21 (0.00%)  0/21 (0.00%) 
Macular degeneration  1  0/41 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/21 (0.00%)  1/21 (4.76%) 
Meibomian gland dysfunction  1  0/41 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/21 (0.00%)  1/19 (5.26%)  0/21 (0.00%)  0/21 (0.00%) 
Ocular discomfort  1  0/41 (0.00%)  0/42 (0.00%)  1/41 (2.44%)  0/40 (0.00%)  0/39 (0.00%)  0/21 (0.00%)  1/19 (5.26%)  1/21 (4.76%)  1/21 (4.76%) 
Ocular hyperaemia  1  0/41 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  1/40 (2.50%)  0/39 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/21 (0.00%)  0/21 (0.00%) 
Photopsia  1  0/41 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/21 (0.00%)  1/21 (4.76%) 
Ulcerative keratitis  1  0/41 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/40 (0.00%)  1/39 (2.56%)  0/21 (0.00%)  0/19 (0.00%)  0/21 (0.00%)  0/21 (0.00%) 
Vision blurred  1  0/41 (0.00%)  0/42 (0.00%)  1/41 (2.44%)  0/40 (0.00%)  0/39 (0.00%)  1/21 (4.76%)  2/19 (10.53%)  1/21 (4.76%)  0/21 (0.00%) 
Visual acuity reduced  1  0/41 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  1/21 (4.76%)  1/19 (5.26%)  0/21 (0.00%)  0/21 (0.00%) 
Gastrointestinal disorders                   
Abdominal pain  1  0/41 (0.00%)  0/42 (0.00%)  1/41 (2.44%)  0/40 (0.00%)  0/39 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/21 (0.00%)  0/21 (0.00%) 
Abdominal pain upper  1  0/41 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  1/21 (4.76%)  0/21 (0.00%) 
Constipation  1  0/41 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/40 (0.00%)  1/39 (2.56%)  0/21 (0.00%)  0/19 (0.00%)  1/21 (4.76%)  0/21 (0.00%) 
Diarrhoea  1  0/41 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/21 (0.00%)  1/21 (4.76%) 
Dry mouth  1  0/41 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  1/21 (4.76%)  0/19 (0.00%)  0/21 (0.00%)  0/21 (0.00%) 
Dyspepsia  1  0/41 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  1/21 (4.76%)  0/21 (0.00%) 
Gastric polyps  1  0/41 (0.00%)  0/42 (0.00%)  1/41 (2.44%)  0/40 (0.00%)  0/39 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/21 (0.00%)  0/21 (0.00%) 
Gastritis  1  0/41 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  1/21 (4.76%)  0/21 (0.00%) 
Salivary gland pain  1  0/41 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  1/21 (4.76%)  0/21 (0.00%) 
Hepatobiliary disorders                   
Hepatic function abnormal  1  1/41 (2.44%)  0/42 (0.00%)  0/41 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/21 (0.00%)  0/21 (0.00%) 
Infections and infestations                   
Adenoviral conjunctivitis  1  0/41 (0.00%)  0/42 (0.00%)  1/41 (2.44%)  0/40 (0.00%)  0/39 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/21 (0.00%)  0/21 (0.00%) 
Dermatitis infected  1  0/41 (0.00%)  0/42 (0.00%)  1/41 (2.44%)  0/40 (0.00%)  0/39 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/21 (0.00%)  0/21 (0.00%) 
Gastroenteritis norovirus  1  0/41 (0.00%)  0/42 (0.00%)  1/41 (2.44%)  0/40 (0.00%)  0/39 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/21 (0.00%)  0/21 (0.00%) 
Gastroenteritis viral  1  0/41 (0.00%)  1/42 (2.38%)  0/41 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/21 (0.00%)  0/21 (0.00%) 
Herpes simplex  1  0/41 (0.00%)  1/42 (2.38%)  0/41 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/21 (0.00%)  0/21 (0.00%) 
Herpes zoster  1  0/41 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  1/21 (4.76%)  0/19 (0.00%)  0/21 (0.00%)  0/21 (0.00%) 
Influenza  1  1/41 (2.44%)  0/42 (0.00%)  0/41 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/21 (0.00%)  0/21 (0.00%) 
Nasopharyngitis  1  2/41 (4.88%)  4/42 (9.52%)  2/41 (4.88%)  5/40 (12.50%)  1/39 (2.56%)  1/21 (4.76%)  0/19 (0.00%)  0/21 (0.00%)  0/21 (0.00%) 
Upper respiratory tract infection  1  0/41 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/21 (0.00%)  1/19 (5.26%)  0/21 (0.00%)  0/21 (0.00%) 
Vaginal infection  1  0/41 (0.00%)  0/42 (0.00%)  0/41 (0.00%)