Safety and Efficacy of KPI-121 Compared to Placebo 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

NCT02819284

Run by

Kala Pharmaceuticals, Inc.

People needed

909

Starts

2016-06-01

Expected to finish

2017-09-01

Last updated by the study team

2021-01-05

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, 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

• Arizona Eye Center — Chandler, Arizona, United States
• NEA Baptist Clinic — Jonesboro, Arkansas, United States
• Sall Research Medical Center — Artesia, California, United States
• Milton M. Hom, OD, FAAO — Azusa, California, United States
• Family Eye Care Center — Campbell, California, United States
• Orange County Ophthalmology — Garden Grove, California, United States
• Lugene Eye Institute — Glendale, California, United States
• The Gavin Herbert Eye Institute — Irvine, California, United States
• Macy Eye Center — Los Angeles, California, United States
• Advanced Vision Care — Los Angeles, California, United States
• North Valley Eye Medical Group — Mission Hills, California, United States
• Eye Research Foundation — Newport Beach, California, United States
• Arch Health Partners — Poway, California, United States
• Martel Eye Medical Group — Rancho Cordova, California, United States
• Shasta Eye Medical Group, Inc — Redding, California, United States
• West Coast Eye Care Associates — San Diego, California, United States
• Wolstan & Goldberg Eye Associates — Torrance, California, United States
• Michael K Tran, M.D., Inc. — Westminster, California, United States
• Hernando Eye Institute — Brooksville, Florida, United States
• Central Florida Eye Associates — Lakeland, Florida, United States
• Shettle Eye Research, Inc — Largo, Florida, United States
• International Eye Associates PA — Ormond Beach, Florida, United States
• Perez Eye Center/International Research Center — Tampa, Florida, United States
• Eye Care Centers Management, Inc. (Clayton Eye Center) — Morrow, Georgia, United States
• UAB School of Optometry — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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