A Phase 3, Double-Masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle in Subjects With Dry Eye Disease
Overview
- Phase
- Phase 3
- Intervention
- KPI-121 0.25% Ophthalmic Suspension
- Conditions
- Dry Eye Syndromes
- Sponsor
- Kala Pharmaceuticals, Inc.
- Enrollment
- 909
- Locations
- 62
- Primary Endpoint
- Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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).
Detailed Description
This is a Phase 3, multi-center, double-masked, randomized, vehicle-controlled, parallel-group study designed to evaluate the safety and efficacy of KPI-121 0.25% ophthalmic suspension versus vehicle in subjects with dry eye disease.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Have a documented clinical diagnosis of dry eye disease in both eyes
Exclusion Criteria
- •Known hypersensitivity or contraindication to the investigational product(s) or components
- •History of glaucoma, IOP\>21 mmHg at the screening or randomization visits, or being treated for glaucoma in either eye.
- •Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in judgment of Investigator could confound study assessments or limit compliance; or have been exposed to an investigational drug within 30 days prior to screening.
- •In the opinion of the Investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops.
Arms & Interventions
KPI-121 0.25% Ophthalmic Suspension
Intervention: KPI-121 0.25% Ophthalmic Suspension
Vehicle of KPI-121 0.25% Ophthalmic Suspension
Intervention: Vehicle of KPI-121 0.25% Ophthalmic Suspension
Outcomes
Primary Outcomes
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)
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.
Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15)
Time Frame: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
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.
Secondary Outcomes
- Proportion of Subjects With ≥ 1 Unit Improvement From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia Worst Region at Visit 4 (Day 15)(Baseline/Visit 2 (Day 1) - Visit 4 (Day 15))
- Change From Baseline/ Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Visit 3 (Day 8)(Baseline/Visit 2 (Day 1) - Visit 3 (Day 8))
- Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Scores to Day 4(Baseline/Visit 2 (Day 1) - Day 4)
- Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Day 3 (Diary)(Baseline/Visit 2 (Day 1) - Day 3)
- Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at Visit 4 (Day 15)(Baseline/Visit 2 (Day 1) - Visit 4 (Day 15))
- Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at Visit 3 (Day 8)(Baseline/Visit 2 (Day 1) - Visit 3 (Day 8))
- Ocular Discomfort Severity Scores on Day 2 (Diary) Minus Baseline/Visit 2 (Day 1)(Baseline/Visit 2 (Day 1) - Day 1)
- Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Frequency Scores at Visit 4 (Day 15)(Baseline/Visit 2 (Day 1) - Visit 4 (Day 15))
- Change From Baseline/Visit 2 (Day 1) in Subject-rated Ocular Discomfort Frequency Scores at Visit 3 (Day 8)(Baseline/Visit 2 (Day 1) - Visit 3 (Day 8))
- Change From Baseline/Visit 2 (Day 1) in Inferior Corneal Fluorescein Staining Score at Visit 4 (Day 15)(Baseline/Visit 2 (Day 1) - Visit 4 (Day 15))
- Change From Baseline/Visit 2 (Day 1) in Nasal Corneal Fluorescein Staining Score at Visit 4 (Day 15)(Baseline/Visit 2 (Day 1) - Visit 4 (Day 15))
- Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) in a Subgroup(Baseline/Visit 2 (Day 1) - Visit 4 (Day 15))