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

Completed · Phase 2 · 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 28 days, with 1-2 drops instilled in each eye four times daily (QID).

Key facts

Study ID

NCT02188160

Run by

Kala Pharmaceuticals, Inc.

People needed

150

Starts

2014-06-01

Expected to finish

2015-03-01

Last updated by the study team

2021-01-06

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/contraindication to study 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; 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.
• 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

• Sall Research Medical Center — Artesia, California, United States
• North Valley Eye Medical Group — Mission Hills, California, United States
• Martel Eye Medical Group — Rancho Cordova, California, United States
• Eye Center of Southern CT, P.C. — Hamden, Connecticut, United States
• Price Vision Group — Indianapolis, Indiana, United States
• Ophthalmology Associates — St Louis, Missouri, United States
• Comprehensive Eye Care, Ltd. / Vision Research Institute, LLC — Washington, Missouri, United States
• South Shore Eye Center, LLP — Wantagh, New York, United States
• Abrams Eye Center — Cleveland, Ohio, United States
• Total Eye Care, PA — Memphis, Tennessee, United States
• Whitsett Vision Group — Houston, Texas, United States

Full record on ClinicalTrials.gov

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