A Phase II, Double-Masked, Randomized, Vehicle-Controlled Study to Evaluate the Effect of KPI-121 0.25% Ophthalmic Suspension on Signs and Symptoms of Inflammatory Meibomian Gland Disease
Overview
- Phase
- Phase 2
- Intervention
- Vehicle
- Conditions
- Blepharitis
- Sponsor
- Kala Pharmaceuticals, Inc.
- Enrollment
- 206
- Locations
- 8
- Primary Endpoint
- Change From Baseline in Ocular Discomfort
- 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 ophthalmic suspension compared to vehicle (placebo) in subjects with signs and symptoms of inflammatory meibomian gland disease.
Detailed Description
This is a Phase II, multicenter, double-masked, randomized, vehicle-controlled, parallel-group study designed to evaluate the efficacy and safety of KPI-121 ophthalmic suspension versus vehicle in subjects with signs and symptoms of inflammatory meibomian gland disease. The product will be studied over 28 days, with 1-2 drops instilled in each eye four times daily (QID).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Have a documented clinical diagnosis of inflammatory meibomian gland disease in both eyes.
Exclusion Criteria
- •Known hypersensitivity/contraindication to study product(s) or components.
- •Be currently receiving treatment for glaucoma, have history of or current glaucoma, or an IOP (intraocular pressure) over 21mmHg at Visit 1 (Screening) or Visit 2 (Randomization).
- •Be unwilling to discontinue warm compress therapy, lid expression, or lid massage 14 days prior to Day 1 and for the duration of the study.
- •Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in judgment of Investigator could confound study assessments or limit compliance; severe/serious systemic disease or uncontrolled medical condition that in judgment of Investigator could confound study assessments or limit compliance; or have been exposed to an investigational drug within the 30 days prior to screening.
- •Have had ocular surgery in the past 90 days or require ocular surgery during the study.
- •In the opinion of Investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops.
Arms & Interventions
Vehicle
Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease
Intervention: Vehicle
KPI-121 0.25% Ophthalmic Suspension
KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease
Intervention: KPI-121
Outcomes
Primary Outcomes
Change From Baseline in Ocular Discomfort
Time Frame: Visit 2 (Day 1) to Visit 4 (Day 15)
Comparison of change from baseline in 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 at Visit 4 (Day 15).
Change From Baseline in Posterior Lid Margin Hyperemia in the Subgroup of Subjects With Greater Hyperemia at Baseline
Time Frame: Visit 2 (Day 1) to Visit 4 (Day 15)
Comparison of change from baseline in posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group in subjects with greater baseline hyperemia at Visit 4 (Day 15). The scale for posterior lid margin hyperemia was scored on a range from 0-4 with the following description: 0=normal 1. mild 2. moderate 3. severe 4. very severe
Secondary Outcomes
- Change From Baseline in Posterior Lid Margin Hyperemia(Visit 2 (Day 1) to Visit 6 (Day 29))
- Change From Baseline in Ocular Discomfort(Visit 2 (Day 1) to Visit 6 (Day 29))
- Change From Baseline in Posterior Lid Margin Hyperemia in the Subgroup of Subjects With Greater Hyperemia at Baseline(Visit 2 (Day 1) to Visit 6 (Day 29))