Status:
COMPLETED
A Study to Confirm the Efficacy and Safety of K-161 Ophthalmic Solution for Treatment of Moderate to Severe Dry Eye Disease
Lead Sponsor:
Kowa Research Institute, Inc.
Conditions:
Dry Eye Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2023
Estimated Enrollment :
644 Patients enrolled
Trial Details
Trial ID
NCT05403827
Start Date
July 3 2022
End Date
December 5 2023
Last Update
January 14 2025
Active Locations (51)
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1
The University of Alabama at Birmingham School of Optometry, Clinical Eye Research Center
Birmingham, Alabama, United States, 35294
2
Trinity Research Group
Dothan, Alabama, United States, 36301
3
Cornea and Cataract Consultants of Arizona
Phoenix, Arizona, United States, 85032
4
Citrus Valley Eyecare / Premiere Practice Management, LLC
Covina, California, United States, 91723