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

Kala Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Blepharitis

Treatments

Drug: KPI-121

Drug: Vehicle

Study type

Interventional

Funder types

Industry

Identifiers

NCT02218489

KPI-121-C-003

Details and patient eligibility

About

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.

Full 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).

Enrollment

206 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.