A Study to Confirm the Efficacy and Safety of K-161 Ophthalmic Solution for Treatment of Moderate to Severe Dry Eye Disease
Phase 3
Completed
- Conditions
- Dry Eye Disease
- Registration Number
- NCT05403827
- Lead Sponsor
- Kowa Research Institute, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 644
Inclusion Criteria
Inclusion Criteria:<br><br> - Be at least 18 years of age at the time of Informed Consent<br><br> - Have a reported history of dry eye disease in both eyes and a history of eye drop<br> use for dry eye symptom<br><br> - Meet all other inclusion criteria outlined in the clinical study protocol<br><br>Exclusion Criteria:<br><br> - Have any clinically significant ocular condition<br><br> - Have a history of corneal refractive surgery and/or any other ocular surgical<br> procedure within 12 months<br><br> - Meet any other exclusion criteria outlined in the clinical study protocol
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in eye dryness score (EDS);Change in conjunctival sum fluorescein staining score.
- Secondary Outcome Measures
Name Time Method Change in total eye sum fluorescein staining score;Change in corneal sum fluorescein staining score;Change in ocular surface disease index (OSDI);Change in Schirmer's test;Change in tear film break-up time (TFBUT);Safety and Tolerability of K-161 in participants with DED