Overview

This trial has been completed.

Condition blepharitis
Treatments kpi-121, vehicle
Phase phase 2
Sponsor Kala Pharmaceuticals, Inc.
Start date July 2014
End date December 2015
Trial size 206 participants
Trial identifier NCT02218489, KPI-121-C-003

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease
vehicle KPI-121 0.25% Vehicle
The vehicle control has the same composition as KPI-121 0.25% ophthalmic suspension except it does not contain LE. 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.
(Active Comparator)
KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease
kpi-121 KPI-121 0.25% Ophthalmic Suspension
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.

Primary Outcomes

Measure
Posterior Lid Margin Hyperemia
time frame: Day 29
Ocular Discomfort
time frame: Day 22 to Day 29

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: Have a documented clinical diagnosis of inflammatory meibeomian 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 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.

Additional Information

Official title 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
Principal investigator Marc Abrams, MD
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).
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Kala Pharmaceuticals, Inc..