A Study to Investigate the Safety and Efficacy of K-321 Eye Drops After Simultaneous Cataract Surgery and Descemetorhexis in Participants With Fuchs Endothelial Corneal Dystrophy (FECD)

Trial ID or NCT#

NCT05826353

Status

not recruiting iconNOT RECRUITING

Purpose

A study to assess the safety and efficacy of K-321 in participants with FECD after simultaneous cataract surgery and descemetorhexis.

Official Title

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 Simultaneous Cataract Surgery and Descemetorhexis in Subjects With Fuchs Endothelial Corneal Dystrophy

Eligibility Criteria

Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

Investigator(s)

Charles C. Lin, MD
Charles C. Lin, MD
Cornea specialist, Cataract specialist
Clinical Associate Professor, Ophthalmology

Contact us to find out if this trial is right for you.

Contact

Director, Clinical Operations
919-433-1621