Safety and Efficacy of KPI-121 in Subjects With Inflammatory Meibomian Gland Disease

Phase 2

Completed

• Conditions: Blepharitis
• Interventions: Drug: Vehicle; Drug: KPI-121

• Registration Number: NCT02218489
• Lead Sponsor: Kala Pharmaceuticals, Inc.

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).

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-08-13
• Study First Submitted QC: 2014-08-14
• Study First Posted: 2014-08-18
• Primary Completion: 2015-12
• Study Completion: 2016-06
• Disposition First Submitted: 2016-10-19
• Disposition First Submitted QC: 2016-10-19
• Disposition First Posted: 2016-10-20
• Results First Submitted: 2020-11-25
• Status Verified: 2021-01
• Results First Submitted QC: 2021-01-06
• Last Update Submitted: 2021-01-06
• Results First Posted: 2021-01-11
• Last Update Posted: 2021-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Vehicle	Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease
KPI-121 0.25% Ophthalmic Suspension	KPI-121	KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Ocular Discomfort	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	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 Outcome Measures

Name	Time	Method
Change From Baseline in Posterior Lid Margin Hyperemia	Visit 2 (Day 1) to Visit 6 (Day 29)	Comparison of change from baseline in posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group at Visit 6 (Day 29). 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
Change From Baseline in Ocular Discomfort	Visit 2 (Day 1) to Visit 6 (Day 29)	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 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)	Comparison of change from baseline in posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group in the subgroup of subjects with greater hyperemia at baseline at Visit 6 (Day 29). 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

Trial Locations

Locations (8)

Abrams Eye Center; 🇺🇸 Cleveland, Ohio, United States

Sall Research Medical Center; 🇺🇸 Artesia, California, United States

Wolstan & Goldberg Eye Associates; 🇺🇸 Torrance, California, United States

UAB School of Optometry; 🇺🇸 Birmingham, Alabama, United States

North Valley Eye Medical Group; 🇺🇸 Mission Hills, California, United States

Virginia Eye Consultants; 🇺🇸 Norfolk, Virginia, United States

Tauber Eye Center; 🇺🇸 Kansas City, Missouri, United States

South Shore Eye Center, LLP; 🇺🇸 Wantagh, New York, United States