Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease

Completed · Phase 3 · Has a placebo group

Conditions studied: Dry Eye Syndromes, Keratoconjunctivitis Sicca

In brief

The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25% ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented clinical diagnosis of dry eye disease. The product will be studied over 14 days, with 1-2 drops instilled in each eye four times daily (QID).

Key facts

Study ID

NCT02813265

Run by

Kala Pharmaceuticals, Inc.

People needed

918

Starts

2016-06-01

Expected to finish

2017-10-01

Last updated by the study team

2021-02-03

Who can join

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

You may qualify if…

• Have a documented clinical diagnosis of dry eye disease in both eyes

You may not qualify if…

• Known hypersensitivity or contraindication to the investigational product(s) or components
• History of glaucoma, Intraocular Pressure (IOP) >21 mmHg at the screening or randomization visits, or being treated for glaucoma in either eye.
• Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in judgment of Investigator could confound study assessments or limit compliance; or have been exposed to an investigational drug within 30 days prior to screening.
• In the opinion of the Investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops.

Where it is running

• Schwartz Laser Eye Center — Scottsdale, Arizona, United States
• Eyecare Arkansas, P.A. — Little Rock, Arkansas, United States
• Little Rock Eye Clinic, LLP — Little Rock, Arkansas, United States
• Sall Research Medical Center — Artesia, California, United States
• Orange County Ophthalmology Medical Group — Garden Grove, California, United States
• United Medical Research Institute — Inglewood, California, United States
• North Valley Eye Medical Group — Mission Hills, California, United States
• Montebello Medical Center, Inc. — Montebello, California, United States
• LoBue Laser and Eye Medical Center — Murrieta, California, United States
• Eye Research Foundation — Newport Beach, California, United States
• Pendleton Eye Center — Oceanside, California, United States
• North Bay Eye Associates, Inc. — Petaluma, California, United States
• Martel Eye Medical Group — Rancho Cordova, California, United States
• Sacramento Eye Consultants — Sacramento, California, United States
• Eye Center of Northern Colorado, PC — Fort Collins, Colorado, United States
• Corneal Consultants of Colorado — Littleton, Colorado, United States
• The Eye Center of Southern CT, P.C. — Hamden, Connecticut, United States
• Florida Eye Microsurgical Institute, Inc. — Boynton Beach, Florida, United States
• Eye Associates of Fort Myers — Fort Myers, Florida, United States
• Shettle Eye Research, Inc. — Largo, Florida, United States
• Atlantic Eye Center — Palm Coast, Florida, United States
• The Eye Center of North Florida — Panama City, Florida, United States
• Dixon Eye Care — Albany, Georgia, United States
• Jacksoneye, S. C. — Lake Villa, Illinois, United States
• Cornea and Cataract Consultants of Arizona — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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