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