Safety and Efficacy of KPI-121 Compared to Placebo in Subjects With Dry Eye Disease
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Kala Pharmaceuticals, Inc.
- Study ID
- NCT02819284
- Phase
- PHASE3
- Status
- Completed
Conditions
- Dry Eye Syndromes
- Keratoconjunctivitis Sicca
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- KPI-121 0.25% Ophthalmic Suspension — DRUG
- Vehicle of KPI-121 0.25% Ophthalmic Suspension — DRUG
Study Details
The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25% ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented clinical diagnosis of dry eye disease. The product will be studied over 14 days, with 1-2 drops instilled in each eye four times daily (QID).
Key Dates
- Start date
- Jun 30, 2016
- Status verified
- Nov 2020
- Primary completion
- Sep 30, 2017
- Completion
- Sep 30, 2017
Study Design
- Enrollment
- 909 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: KPI-121 0.25% Ophthalmic Suspension
- Placebo Comparator: Vehicle of KPI-121 0.25% Ophthalmic Suspension
Primary Outcome Measure
Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15) [ Time Frame: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15) ]
Locations (62)
Find similar trials in Birmingham, AL
Related Studies
- Clinical Applications of Advanced Ophthalmic ImagingRecruiting · University of Miami · Miami, Florida
- Study of Platelet Rich Plasma Drops to Moderate Clinically Significant Dry EyeNot Yet Recruiting · University of Rochester · Rochester, New York
- The Effect of Rinsing on Ocular Inflammation and Symptoms in Patients With Dry Eye DiseaseRecruiting · Rinsada · Pittsburgh, Pennsylvania