A Study Assessing the Safety, Efficacy, and Optimum Dosage of K-161 in Subjects With Moderate to Severe Dry Eye Disease

• Status: Completed
• Trial end date: 2020-01-09
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the study is to assess the safety, efficacy, optimum dosage, and dosing regimen of K-161 in adult subjects with moderate to severe dry eye disease.

• Phase: Phase 2
• 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 visit.

• Have a reported history of dry eye disease in both eyes and a history of eye drop use for dry eye symptoms.

• Meet all 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.

• Must not meet any other exclusion criteria outlined in the clinical study protocol.