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A Double-Masked, Randomized, Placebo-Controlled, Parallel-Group, 12-Week Administration With Two-Week Gradual Dose Taper Phase and 38-Week Follow-Up Phase, Phase 3 Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Descemetorhexis in Subjects With Fuchs Endothelial Corneal Dystrophy
A study to assess the safety and efficacy of K-321 in participants with FECD after descemetorhexis.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Keck Hospital of USC
Los Angeles, California, United States
Macy Eye Center
Los Angeles, California, United States
Jules Stein Eye Institute
Los Angeles, California, United States
Byers Eye Institute at Stanford
Palo Alto, California, United States
Sacramento Eye Consultants
Sacramento, California, United States
Gorovoy MD Eye Specialists
Fort Myers, Florida, United States
University of Florida
Gainesville, Florida, United States
Bascom Palmer Eye Institute
Miami, Florida, United States
Bascom Palmer Eye Institute - Naples
Naples, Florida, United States
Eye Consultants of Atlanta
Atlanta, Georgia, United States
Start Date
March 30, 2023
Primary Completion Date
May 22, 2025
Completion Date
March 1, 2026
Last Updated
June 22, 2025
107
ACTUAL participants
Ripasudil
DRUG
Placebo
DRUG
Lead Sponsor
Kowa Research Institute, Inc.
NCT07024693
NCT04440280
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06966167