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

Completed · Phase 2 · Has a placebo group

Conditions studied: Blepharitis

In brief

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.

Key facts

Study ID

NCT02218489

Run by

Kala Pharmaceuticals, Inc.

People needed

206

Starts

2014-07-01

Expected to finish

2016-06-01

Last updated by the study team

2021-01-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a documented clinical diagnosis of inflammatory meibomian gland disease in both eyes.

You may not qualify if…

• 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.

Where it is running

• 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
• Tauber Eye Center — Kansas City, Missouri, United States
• South Shore Eye Center, LLP — Wantagh, New York, United States
• Abrams Eye Center — Cleveland, Ohio, United States
• Virginia Eye Consultants — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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