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Safety and Efficacy of KPI-121 Compared to Placebo in Subjects With Dry Eye Disease (STRIDE 2)

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: NCT02819284
Recruitment Status : Completed
First Posted : June 30, 2016
Results First Posted : December 3, 2020
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Kala Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Dry Eye Syndromes
Keratoconjunctivitis Sicca
Interventions Drug: KPI-121 0.25% Ophthalmic Suspension
Drug: Vehicle of KPI-121 0.25% Ophthalmic Suspension
Enrollment 909
Recruitment Details  
Pre-assignment Details 909 subjects were randomized, 4 of which were not included in any analysis population as agreed upon with the FDA. 3 individuals had participated in more than one study therefore the data for their second-participation were not included and 1 individual did not receive treatment.
Arm/Group Title KPI-121 0.25% Ophthalmic Suspension Vehicle of KPI-121 0.25% Ophthalmic Suspension
Hide Arm/Group Description Participants randomized to KPI-121 0.25% Ophthalmic Suspension Participants randomized to Vehicle of KPI-121 0.25% Ophthalmic Suspension
Period Title: Overall Study
Started 452 453
Completed 447 448
Not Completed 5 5
Arm/Group Title KPI-121 0.25% Ophthalmic Suspension Vehicle of KPI-121 0.25% Ophthalmic Suspension Total
Hide Arm/Group Description Participants randomized to KPI-121 0.25% Ophthalmic Suspension Participants randomized to Vehicle of KPI-121 0.25% Ophthalmic Suspension Total of all reporting groups
Overall Number of Baseline Participants 452 453 905
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 452 participants 453 participants 905 participants
59.1  (14.48) 59.3  (15.01) 59.2  (14.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 452 participants 453 participants 905 participants
Female
332
  73.5%
354
  78.1%
686
  75.8%
Male
120
  26.5%
99
  21.9%
219
  24.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 452 participants 453 participants 905 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
39
   8.6%
35
   7.7%
74
   8.2%
Native Hawaiian or Other Pacific Islander
1
   0.2%
1
   0.2%
2
   0.2%
Black or African American
58
  12.8%
54
  11.9%
112
  12.4%
White
345
  76.3%
352
  77.7%
697
  77.0%
More than one race
2
   0.4%
2
   0.4%
4
   0.4%
Unknown or Not Reported
7
   1.5%
9
   2.0%
16
   1.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 452 participants 453 participants 905 participants
452 453 905
1.Primary Outcome
Title Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15)
Hide Description Comparison of mean change from baseline for bulbar conjunctival hyperemia in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-4 grading scale. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe.
Time Frame Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed.
Arm/Group Title KPI-121 0.25% Ophthalmic Suspension Vehicle of KPI-121 0.25% Ophthalmic Suspension
Hide Arm/Group Description:
Participants randomized to KPI-121 0.25% Ophthalmic Suspension
Participants randomized to Vehicle of KPI-121 0.25% Ophthalmic Suspension
Overall Number of Participants Analyzed 446 447
Mean (Standard Deviation)
Unit of Measure: score on a scale
-0.3812  (0.60560) -0.2371  (0.62256)
2.Primary Outcome
Title Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15)
Hide Description Comparison of mean ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.
Time Frame Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed.
Arm/Group Title KPI-121 0.25% Ophthalmic Suspension Vehicle of KPI-121 0.25% Ophthalmic Suspension
Hide Arm/Group Description:
Participants randomized to KPI-121 0.25% Ophthalmic Suspension
Participants randomized to Vehicle of KPI-121 0.25% Ophthalmic Suspension
Overall Number of Participants Analyzed 445 444
Mean (Standard Deviation)
Unit of Measure: score on a scale
-11.14  (19.901) -9.24  (17.002)
3.Secondary Outcome
Title Proportion of Subjects With ≥ 1 Unit Improvement From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia Worst Region at Visit 4 (Day 15)
Hide Description Proportion of subjects with ≥1 improvement from baseline in conjunctival hyperemia scores in the study eye. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe.
Time Frame Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed.
Arm/Group Title KPI-121 0.25% Ophthalmic Suspension Vehicle of KPI-121 0.25% Ophthalmic Suspension
Hide Arm/Group Description:
Participants randomized to KPI-121 0.25% Ophthalmic Suspension
Participants randomized to Vehicle of KPI-121 0.25% Ophthalmic Suspension
Overall Number of Participants Analyzed 446 447
Measure Type: Count of Participants
Unit of Measure: Participants
171
  38.3%
127
  28.4%
4.Secondary Outcome
Title Change From Baseline/ Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Visit 3 (Day 8)
Hide Description Comparison of ocular discomfort scores between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse using 3-day mean scores.
Time Frame Baseline/Visit 2 (Day 1) - Visit 3 (Day 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed.
Arm/Group Title KPI-121 0.25% Ophthalmic Suspension Vehicle of KPI-121 0.25% Ophthalmic Suspension
Hide Arm/Group Description:
Participants randomized to KPI-121 0.25% Ophthalmic Suspension
Participants randomized to Vehicle of KPI-121 0.25% Ophthalmic Suspension
Overall Number of Participants Analyzed 449 451
Mean (Standard Deviation)
Unit of Measure: score on a scale
-6.92  (15.541) -4.86  (14.911)
5.Secondary Outcome
Title Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Scores to Day 4
Hide Description Comparison of mean ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.
Time Frame Baseline/Visit 2 (Day 1) - Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed.
Arm/Group Title KPI-121 0.25% Ophthalmic Suspension Vehicle of KPI-121 0.25% Ophthalmic Suspension
Hide Arm/Group Description:
Participants randomized to KPI-121 0.25% Ophthalmic Suspension
Participants randomized to Vehicle of KPI-121 0.25% Ophthalmic Suspension
Overall Number of Participants Analyzed 447 449
Mean (Standard Deviation)
Unit of Measure: score on a scale
-5.09  (14.523) -4.10  (14.894)
6.Secondary Outcome
Title Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) in a Subgroup
Hide Description Comparison of mean ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse, in a sub-group of participants with more severe ocular discomfort at baseline, using 3 day means.
Time Frame Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
Sub-group of Intent to Treat population with more severe ocular discomfort minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed.
Arm/Group Title KPI-121 0.25% Ophthalmic Suspension Vehicle of KPI-121 0.25% Ophthalmic Suspension
Hide Arm/Group Description:
Participants randomized to KPI-121 0.25% Ophthalmic Suspension
Participants randomized to Vehicle of KPI-121 0.25% Ophthalmic Suspension
Overall Number of Participants Analyzed 254 257
Mean (Standard Deviation)
Unit of Measure: score on a scale
-12.45  (20.352) -9.45  (17.489)
7.Secondary Outcome
Title Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Day 3 (Diary)
Hide Description Comparison of mean ocular discomfort severity between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.
Time Frame Baseline/Visit 2 (Day 1) - Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed.
Arm/Group Title KPI-121 0.25% Ophthalmic Suspension Vehicle of KPI-121 0.25% Ophthalmic Suspension
Hide Arm/Group Description:
Participants randomized to KPI-121 0.25% Ophthalmic Suspension
Participants randomized to Vehicle of KPI-121 0.25% Ophthalmic Suspension
Overall Number of Participants Analyzed 451 449
Mean (Standard Deviation)
Unit of Measure: score on a scale
-3.28  (13.697) -3.15  (14.126)
8.Secondary Outcome
Title Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at Visit 4 (Day 15)
Hide Description Comparison of mean eye dryness between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.
Time Frame Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed.
Arm/Group Title KPI-121 0.25% Ophthalmic Suspension Vehicle of KPI-121 0.25% Ophthalmic Suspension
Hide Arm/Group Description:
Participants randomized to KPI-121 0.25% Ophthalmic Suspension
Participants randomized to Vehicle of KPI-121 0.25% Ophthalmic Suspension
Overall Number of Participants Analyzed 447 445
Mean (Standard Deviation)
Unit of Measure: score on a scale
-14.0  (22.78) -11.5  (20.53)
9.Secondary Outcome
Title Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at Visit 3 (Day 8)
Hide Description Comparison of mean eye dryness between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.
Time Frame Baseline/Visit 2 (Day 1) - Visit 3 (Day 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed.
Arm/Group Title KPI-121 0.25% Ophthalmic Suspension Vehicle of KPI-121 0.25% Ophthalmic Suspension
Hide Arm/Group Description:
Participants randomized to KPI-121 0.25% Ophthalmic Suspension
Participants randomized to Vehicle of KPI-121 0.25% Ophthalmic Suspension
Overall Number of Participants Analyzed 442 447
Mean (Standard Deviation)
Unit of Measure: score on a scale
-9.6  (18.66) -8.0  (18.94)
10.Secondary Outcome
Title Ocular Discomfort Severity Scores on Day 2 (Diary) Minus Baseline/Visit 2 (Day 1)
Hide Description Comparison of mean ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.
Time Frame Baseline/Visit 2 (Day 1) - Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed.
Arm/Group Title KPI-121 0.25% Ophthalmic Suspension Vehicle of KPI-121 0.25% Ophthalmic Suspension
Hide Arm/Group Description:
Participants randomized to KPI-121 0.25% Ophthalmic Suspension
Participants randomized to Vehicle of KPI-121 0.25% Ophthalmic Suspension
Overall Number of Participants Analyzed 451 447
Mean (Standard Deviation)
Unit of Measure: score on a scale
-2.33  (13.707) -2.43  (13.364)
11.Secondary Outcome
Title Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Frequency Scores at Visit 4 (Day 15)
Hide Description Comparison of mean ocular discomfort frequency between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.
Time Frame Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed.
Arm/Group Title KPI-121 0.25% Ophthalmic Suspension Vehicle of KPI-121 0.25% Ophthalmic Suspension
Hide Arm/Group Description:
Participants randomized to KPI-121 0.25% Ophthalmic Suspension
Participants randomized to Vehicle of KPI-121 0.25% Ophthalmic Suspension
Overall Number of Participants Analyzed 445 444
Mean (Standard Deviation)
Unit of Measure: score on a scale
-10.20  (20.722) -8.38  (17.974)
12.Secondary Outcome
Title Change From Baseline/Visit 2 (Day 1) in Subject-rated Ocular Discomfort Frequency Scores at Visit 3 (Day 8)
Hide Description Comparison of mean ocular discomfort frequency between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.
Time Frame Baseline/Visit 2 (Day 1) - Visit 3 (Day 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed.
Arm/Group Title KPI-121 0.25% Ophthalmic Suspension Vehicle of KPI-121 0.25% Ophthalmic Suspension
Hide Arm/Group Description:
Participants randomized to KPI-121 0.25% Ophthalmic Suspension
Participants randomized to Vehicle of KPI-121 0.25% Ophthalmic Suspension
Overall Number of Participants Analyzed 449 451
Mean (Standard Deviation)
Unit of Measure: score on a scale
-5.96  (16.133) -4.42  (16.133)
13.Secondary Outcome
Title Change From Baseline/Visit 2 (Day 1) in Inferior Corneal Fluorescein Staining Score at Visit 4 (Day 15)
Hide Description Comparison of mean corneal fluorescein staining in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using methods developed by the National Eye Institute (NEI) Dry Eye Workshop in evaluating 5 regions of the cornea (superior, inferior, nasal, temporal and central) using a 0-3 grading scale, where 0 = no visible staining, 1 = Mild, 2 = moderate and 3 = severe.
Time Frame Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed.
Arm/Group Title KPI-121 0.25% Ophthalmic Suspension Vehicle of KPI-121 0.25% Ophthalmic Suspension
Hide Arm/Group Description:
Participants randomized to KPI-121 0.25% Ophthalmic Suspension
Participants randomized to Vehicle of KPI-121 0.25% Ophthalmic Suspension
Overall Number of Participants Analyzed 448 448
Mean (Standard Deviation)
Unit of Measure: score on a scale
-0.6  (0.86) -0.5  (0.83)
14.Secondary Outcome
Title Change From Baseline/Visit 2 (Day 1) in Nasal Corneal Fluorescein Staining Score at Visit 4 (Day 15)
Hide Description Comparison of mean nasal corneal fluorescein staining in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using methods developed by the National Eye Institute (NEI) Dry Eye Workshop in evaluating 5 regions of the cornea (superior, inferior, nasal, temporal and central) using a 0-3 grading scale, where 0 = no visible staining, 1 = Mild, 2 = moderate and 3 = severe.
Time Frame Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed.
Arm/Group Title KPI-121 0.25% Ophthalmic Suspension Vehicle of KPI-121 0.25% Ophthalmic Suspension
Hide Arm/Group Description:
Participants randomized to KPI-121 0.25% Ophthalmic Suspension
Participants randomized to Vehicle of KPI-121 0.25% Ophthalmic Suspension
Overall Number of Participants Analyzed 448 448
Mean (Standard Deviation)
Unit of Measure: score on a scale
-0.6  (0.86) -0.4  (0.83)
Time Frame Adverse events were collected from Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Adverse Event Reporting Description Both treatment-related and non-treatment-related adverse events are reported here.
 
Arm/Group Title KPI-121 0.25% Ophthalmic Suspension Vehicle of KPI-121 0.25% Ophthalmic Suspension
Hide Arm/Group Description Participants randomized to KPI-121 0.25% Ophthalmic Suspension Participants randomized to Vehicle of KPI-121 0.25% Ophthalmic Suspension
All-Cause Mortality
KPI-121 0.25% Ophthalmic Suspension Vehicle of KPI-121 0.25% Ophthalmic Suspension
Affected / at Risk (%) Affected / at Risk (%)
Total   0/452 (0.00%)      0/453 (0.00%)    
Hide Serious Adverse Events
KPI-121 0.25% Ophthalmic Suspension Vehicle of KPI-121 0.25% Ophthalmic Suspension
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/452 (0.66%)      0/453 (0.00%)    
Gastrointestinal disorders     
diverticulum intestinal † 1  1/452 (0.22%)  1 0/453 (0.00%)  0
Musculoskeletal and connective tissue disorders     
hip fracture † 1  1/452 (0.22%)  1 0/453 (0.00%)  0
intervertebral disc protrusion † 1  1/452 (0.22%)  1 0/453 (0.00%)  0
1
Term from vocabulary, MedDRA (19.0)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
KPI-121 0.25% Ophthalmic Suspension Vehicle of KPI-121 0.25% Ophthalmic Suspension
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   57/452 (12.61%)      44/453 (9.71%)    
Ear and labyrinth disorders     
Ear pain † 1  1/452 (0.22%)  0/453 (0.00%) 
Eye disorders     
Eye pruritus † 1  3/452 (0.66%)  4/453 (0.88%) 
Conjunctival hyperaemia † 1  2/452 (0.44%)  3/453 (0.66%) 
Eye irritation † 1  2/452 (0.44%)  4/453 (0.88%) 
Eye pain † 1  2/452 (0.44%)  3/453 (0.66%) 
Conjunctival haemorrhage † 1  1/452 (0.22%)  2/453 (0.44%) 
Conjunctival oedema † 1  1/452 (0.22%)  0/453 (0.00%) 
Eye discharge † 1  1/452 (0.22%)  0/453 (0.00%) 
Eyelid pruritus † 1  1/452 (0.22%)  0/453 (0.00%) 
Iritis † 1  1/452 (0.22%)  0/453 (0.00%) 
Ocular hypertension † 1  1/452 (0.22%)  0/453 (0.00%) 
Photophobia † 1  1/452 (0.22%)  1/453 (0.22%) 
Vision blurred † 1  1/452 (0.22%)  6/453 (1.32%) 
Vision acuity reduced † 1  1/452 (0.22%)  0/453 (0.00%) 
Visual impairment † 1  1/452 (0.22%)  0/453 (0.00%) 
Corneal infiltrates † 1  0/452 (0.00%)  1/453 (0.22%) 
Gastrointestinal disorders     
Abdominal pain † 1  1/452 (0.22%)  0/453 (0.00%) 
Constipation † 1  1/452 (0.22%)  0/453 (0.00%) 
Gastroesophogeal reflux disease † 1  1/452 (0.22%)  0/453 (0.00%) 
Nausea † 1  1/452 (0.22%)  1/453 (0.22%) 
Oesophageal rupture † 1  1/452 (0.22%)  0/453 (0.00%) 
General disorders     
Instillation site pain † 1  26/452 (5.75%)  20/453 (4.42%) 
Chest pain † 1  1/452 (0.22%)  0/453 (0.00%) 
Instillation site discharge † 1  1/452 (0.22%)  0/453 (0.00%) 
Instillation site irritation † 1  1/452 (0.22%)  0/453 (0.00%) 
Instillation site pruritus † 1  0/452 (0.00%)  1/453 (0.22%) 
Pyrexia † 1  0/452 (0.00%)  1/453 (0.22%) 
Immune system disorders     
Drug hypersensitivity † 1  1/452 (0.22%)  0/453 (0.00%) 
Infections and infestations     
Herpes zoster † 1  1/452 (0.22%)  0/453 (0.00%) 
Streptococcal infection † 1  1/452 (0.22%)  0/453 (0.00%) 
Tooth infection † 1  1/452 (0.22%)  0/453 (0.00%) 
Body tinea † 1  0/452 (0.00%)  1/453 (0.22%) 
Lower respiratory tract infection † 1  0/452 (0.00%)  1/453 (0.22%) 
Sinusitis † 1  0/452 (0.00%)  1/453 (0.22%) 
Upper respiratory tract infection † 1  0/452 (0.00%)  2/453 (0.44%) 
Vaginal infection † 1  0/452 (0.00%)  1/453 (0.22%) 
Injury, poisoning and procedural complications     
Contusion † 1  1/452 (0.22%)  0/453 (0.00%) 
Joint injury † 1  1/452 (0.22%)  1/453 (0.22%) 
Ligament rupture † 1  1/452 (0.22%)  0/453 (0.00%) 
Investigations     
Intraocular pressure increased † 1  1/452 (0.22%)  0/453 (0.00%) 
Musculoskeletal and connective tissue disorders     
Osteoporosis † 1  1/452 (0.22%)  0/453 (0.00%) 
Nervous system disorders     
Dizziness † 1  1/452 (0.22%)  1/453 (0.22%) 
Headache † 1  1/452 (0.22%)  2/453 (0.44%) 
Ophthalmoplegic migraine † 1  0/452 (0.00%)  1/453 (0.22%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea † 1  1/452 (0.22%)  0/453 (0.00%) 
Nasal congestion † 1  1/452 (0.22%)  0/453 (0.00%) 
Sinus congestion † 1  1/452 (0.22%)  0/453 (0.00%) 
Paranasal sinus hypersecretion † 1  0/452 (0.00%)  1/453 (0.22%) 
Skin and subcutaneous tissue disorders     
Pruritus † 1  0/452 (0.00%)  1/453 (0.22%) 
Rash erythematous † 1  0/452 (0.00%)  1/453 (0.22%) 
Vascular disorders     
Hypertension † 1  1/452 (0.22%)  0/453 (0.00%) 
1
Term from vocabulary, MedDRA (19.0)
†
Indicates events were collected by systematic assessment
[Not Specified]
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.

The agreement between the Principal Investigator and the Sponsor restricts the PI's rights to discuss or publish trial results until after the first to occur of the following:

(a) publication of such multi-center clinical trial results; (b) notification by sponsor that such a multi-center clinical trial submission is no longer planned; or ( c) the eighteen ( 18) month anniversary of the completion, abandonment or termination of such multi-center clinical trial.

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: VP Clinical Development
Organization: Kala Pharmaceuticals, Inc.
Phone: (781) 996-5252
EMail: Results007@kalarx.com
Layout table for additonal information
Responsible Party: Kala Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02819284    
Other Study ID Numbers: KPI-121-C-007
First Submitted: June 28, 2016
First Posted: June 30, 2016
Results First Submitted: September 21, 2020
Results First Posted: December 3, 2020
Last Update Posted: January 5, 2021