Overview

A Study to Confirm the Efficacy and Safety of K-161 Ophthalmic Solution for Treatment of Moderate to Severe Dry Eye Disease

Status:
Recruiting
Trial end date:
2023-10-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to assess the efficacy and safety of K-161 ophthalmic solution for the treatment of moderate to severe dry eye disease.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kowa Research Institute, Inc.
Criteria
Inclusion Criteria:

- Be at least 18 years of age at the time of Informed Consent

- Have a reported history of dry eye disease in both eyes and a history of eye drop use
for dry eye symptom

- Meet all other inclusion criteria outlined in the clinical study protocol

Exclusion Criteria:

- Have any clinically significant ocular condition

- Have a history of corneal refractive surgery and/or any other ocular surgical
procedure within 12 months

- Meet any other exclusion criteria outlined in the clinical study protocol