Overview

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

Status:
Completed
Trial end date:
2017-10-01
Target enrollment:
0
Participant gender:
All
Summary
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kala Pharmaceuticals, Inc.
Treatments:
Loteprednol Etabonate
Criteria
Inclusion Criteria:

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

Exclusion Criteria:

- 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.