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

Kala Pharmaceuticals, Inc.206 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

206

Conditions

Blepharitis

Interventions

KPI-121DRUG

KPI-121 drug product will be supplied in 0.25% strength as a suspension in opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate. Subjects randomized to placebo control arm will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.

VehicleDRUG

The vehicle control has the same composition as KPI-121 0.25% ophthalmic suspension except it does not contain loteprednol etabonate. The vehicle is essentially isotonic and is buffered to maintain pH 5.0 - 7.0. It is a sterile, aqueous solution supplied in the same white, low-density polyethylene plastic dropper bottle with the same white, controlled-drop polyethylene tip and white polypropylene closure as KPI-121 0.25% ophthalmic suspension.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (8)

UAB School of Optometry

Birmingham, Alabama, United States

Sall Research Medical Center

Artesia, California, United States

North Valley Eye Medical Group

Mission Hills, California, United States

Wolstan & Goldberg Eye Associates

Torrance, California, United States

Outcomes

Primary Outcomes

Change From Baseline in Ocular Discomfort

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).

Time frame: Visit 2 (Day 1) to Visit 4 (Day 15)

Change From Baseline in Posterior Lid Margin Hyperemia in the Subgroup of Subjects With Greater Hyperemia at Baseline

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

Time frame: Visit 2 (Day 1) to Visit 4 (Day 15)

Secondary Outcomes

Change From Baseline in Ocular Discomfort

Time frame: 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

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

Time frame: Visit 2 (Day 1) to Visit 6 (Day 29)

Change From Baseline in Posterior Lid Margin Hyperemia

Data from ClinicalTrials.gov

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