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Safety and Efficacy Study of New Eye Drop Formulations With Refresh Tears® in Patients With Dry Eye Disease

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ClinicalTrials.gov Identifier: NCT01294384
Recruitment Status : Completed
First Posted : February 11, 2011
Results First Posted : November 25, 2013
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Dry Eye Syndromes
Interventions Drug: carboxymethylcellulose sodium based New Eye Drop Formulation 1
Drug: carboxymethylcellulose sodium based New Eye Drop Formulation 2
Drug: carboxymethylcellulose sodium based Eye Drops
Enrollment 305
Recruitment Details  
Pre-assignment Details  
Arm/Group Title New Eye Drop Formulation 1 New Eye Drop Formulation 2 Refresh Tears®
Hide Arm/Group Description 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days. 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days. 1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
Period Title: Overall Study
Started 101 100 104
Completed 97 94 95
Not Completed 4 6 9
Arm/Group Title New Eye Drop Formulation 1 New Eye Drop Formulation 2 Refresh Tears® Total
Hide Arm/Group Description 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days. 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days. 1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days. Total of all reporting groups
Overall Number of Baseline Participants 101 100 104 305
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 101 participants 100 participants 104 participants 305 participants
< 40 years 9 13 7 29
40 to 60 years 42 33 43 118
> 60 years 50 54 54 158
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 100 participants 104 participants 305 participants
Female
78
  77.2%
80
  80.0%
90
  86.5%
248
  81.3%
Male
23
  22.8%
20
  20.0%
14
  13.5%
57
  18.7%
1.Primary Outcome
Title Change From Baseline in Ocular Surface Disease Index© (OSDI) Score
Hide Description The OSDI is a questionnaire consisting of 12 questions assessing severity of dry eye using a 5-point scale where 0=none of the time to 4=all of the time. The total score is the sum of the individual scores normalized (standardized) to a severity scale of 0=no symptoms (best score) to 100=maximum severity (worst score). A negative change from Baseline indicated improvement.
Time Frame Baseline, Day 90
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to-Treat population, that included all randomized participants.
Arm/Group Title New Eye Drop Formulation 1 New Eye Drop Formulation 2 Refresh Tears®
Hide Arm/Group Description:
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
Overall Number of Participants Analyzed 101 100 104
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline 36.83  (13.350) 38.51  (12.512) 38.86  (11.880)
Change from Baseline at Day 90 -14.72  (16.319) -12.75  (17.612) -14.49  (16.443)
2.Secondary Outcome
Title Change From Baseline in Visual Analog (VAS) Symptom Scale: Dryness
Hide Description The participant rated the severity of their dry eye symptom: dryness using a VAS scale. Participants put a mark on a 100 millimeter line where 0 (far left on the line)=no symptoms to 100 (far right on the line)=most severe symptoms.
Time Frame Baseline, Day 90
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to-Treat population, that included all randomized participants.
Arm/Group Title New Eye Drop Formulation 1 New Eye Drop Formulation 2 Refresh Tears®
Hide Arm/Group Description:
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
Overall Number of Participants Analyzed 101 100 104
Mean (Standard Deviation)
Unit of Measure: millimeters
Baseline 61.1  (22.10) 64.0  (19.05) 60.9  (18.98)
Change from Baseline at Day 90 -24.2  (30.78) -19.2  (29.44) -20.9  (29.20)
3.Secondary Outcome
Title Percentage of Participants Much Better or Better in Near Visual Acuity (Low Contrast)
Hide Description Near Visual Acuity was determined using the number of letters read correctly on a low contrast eye chart (gray letters on a white background). An increase in the number of letters read correctly indicated improvement. Much Better is defined as an increase of 10 or more letters read correctly at Day 90 compared to the worse eye at Baseline. Better is defined as an increase of 5 to 9 letters read correctly at Day 90 compared to the worse eye at Baseline.
Time Frame Baseline, Day 90
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to-Treat population, that included all randomized participants.
Arm/Group Title New Eye Drop Formulation 1 New Eye Drop Formulation 2 Refresh Tears®
Hide Arm/Group Description:
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
Overall Number of Participants Analyzed 101 100 104
Measure Type: Number
Unit of Measure: Percentage of participants
Much better 5.0 8.0 5.8
Better 22.0 21.0 30.8
4.Secondary Outcome
Title Percentage of Participants Much Better or Better in Near Visual Acuity (High Contrast)
Hide Description Near Visual Acuity was determined using the number of letters read correctly on a high contrast eye chart (black letters on a white background). An increase in the number of letters read correctly indicated improvement. Much Better is defined as an increase of 10 or more letters read correctly at Day 90 compared to the worse eye at Baseline. Better is defined as an increase of 5 to 9 letters read correctly at Day 90 compared to the worse eye at Baseline.
Time Frame Baseline, Day 90
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to-Treat population, that included all randomized participants.
Arm/Group Title New Eye Drop Formulation 1 New Eye Drop Formulation 2 Refresh Tears®
Hide Arm/Group Description:
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
Overall Number of Participants Analyzed 101 100 104
Measure Type: Number
Unit of Measure: Percentage of participants
Much Better 7.0 6.0 4.8
Better 15.0 20.0 22.1
5.Secondary Outcome
Title Change From Baseline in Tear Break-Up Time (TBUT)
Hide Description TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from Baseline indicated improvement.
Time Frame Baseline, Day 90
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to-Treat population, that included all randomized participants.
Arm/Group Title New Eye Drop Formulation 1 New Eye Drop Formulation 2 Refresh Tears®
Hide Arm/Group Description:
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
Overall Number of Participants Analyzed 101 100 104
Mean (Standard Deviation)
Unit of Measure: Seconds
Baseline 5.24  (2.007) 5.22  (1.870) 5.05  (1.894)
Change from Baseline at Day 90 1.65  (4.268) 1.97  (3.294) 1.27  (2.837)
6.Secondary Outcome
Title Change From Baseline in Corneal Staining
Hide Description The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining following administration of fluorescein dye in the eye is graded using a 6-point scale where 0=no staining to 5=severe staining over 5 areas of the clear central part of the eye for a minimum score of 0 and maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative number change from baseline represented a decrease in corneal staining (improvement).
Time Frame Baseline, Day 90
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to-Treat population, that included all randomized participants.
Arm/Group Title New Eye Drop Formulation 1 New Eye Drop Formulation 2 Refresh Tears®
Hide Arm/Group Description:
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
Overall Number of Participants Analyzed 101 100 104
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline 6.4  (4.97) 6.1  (4.25) 5.8  (4.29)
Change from Baseline at Day 90 -2.3  (3.75) -2.0  (3.36) -1.2  (3.13)
7.Secondary Outcome
Title Change From Baseline in Conjunctival Staining
Hide Description The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale where 0=no staining to 5=severe staining over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. A negative number change from baseline represented a decrease in the severity of conjunctival staining (improvement).
Time Frame Baseline, Day 90
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to-Treat population, that included all randomized participants.
Arm/Group Title New Eye Drop Formulation 1 New Eye Drop Formulation 2 Refresh Tears®
Hide Arm/Group Description:
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
Overall Number of Participants Analyzed 101 100 104
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline 8.0  (5.34) 7.8  (5.45) 8.2  (5.44)
Change from Baseline at Day 90 -2.7  (4.72) -2.4  (4.06) -2.7  (4.36)
8.Secondary Outcome
Title Change From Baseline in Schirmer Test
Hide Description The Schirmer Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye where Normal=greater than or equal to 10 millimeters (mm) of tears and Dry Eye=less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicated an increase in tears (improvement).
Time Frame Baseline, Day 90
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to-Treat population, that included all randomized participants.
Arm/Group Title New Eye Drop Formulation 1 New Eye Drop Formulation 2 Refresh Tears®
Hide Arm/Group Description:
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
Overall Number of Participants Analyzed 101 100 104
Mean (Standard Deviation)
Unit of Measure: mm
Baseline 8.7  (6.96) 10.3  (7.17) 8.9  (6.16)
Change from Baseline at Day 90 1.2  (7.07) 1.5  (6.12) 1.1  (7.07)
Time Frame [Not Specified]
Adverse Event Reporting Description The safety population, that included all participants who received at least one dose of study treatment, was used to calculate the number of participants at risk for Adverse Events. (One randomized patient did not receive treatment and two patients received treatment but were not randomized.)
 
Arm/Group Title New Eye Drop Formulation 1 New Eye Drop Formulation 2 Refresh Tears®
Hide Arm/Group Description 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days. 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days. 1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
All-Cause Mortality
New Eye Drop Formulation 1 New Eye Drop Formulation 2 Refresh Tears®
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
New Eye Drop Formulation 1 New Eye Drop Formulation 2 Refresh Tears®
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/102 (1.96%)   2/101 (1.98%)   1/103 (0.97%) 
Ear and labyrinth disorders       
Meniere's disease * 1  1/102 (0.98%)  0/101 (0.00%)  0/103 (0.00%) 
Infections and infestations       
Pelvic inflammatory disease  1  0/102 (0.00%)  1/101 (0.99%)  0/103 (0.00%) 
Injury, poisoning and procedural complications       
Ligament rupture  1  1/102 (0.98%)  0/101 (0.00%)  0/103 (0.00%) 
Nervous system disorders       
Neuropathy peripheral * 1  0/102 (0.00%)  0/101 (0.00%)  1/103 (0.97%) 
Vascular disorders       
Hypertension  1  0/102 (0.00%)  1/101 (0.99%)  0/103 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
New Eye Drop Formulation 1 New Eye Drop Formulation 2 Refresh Tears®
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/102 (0.00%)   0/101 (0.00%)   0/103 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title: Therapeutic Area Head,
Organization: Allergan, Inc
Phone: 714-246-4500
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01294384     History of Changes
Other Study ID Numbers: 10078X-001
First Submitted: February 10, 2011
First Posted: February 11, 2011
Results First Submitted: September 24, 2013
Results First Posted: November 25, 2013
Last Update Posted: November 25, 2013