Overview

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

Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kala Pharmaceuticals, Inc.
Treatments:
Loteprednol Etabonate
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.