UK Center for Clinical and Translational Science

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)

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

Is at least 18 years old at the screening visit (Visit 1) - Has a diagnosis of FECD at Visit 1 - Meet all other inclusion criteria outlined in the Clinical Study Protocol.

Is a female subject of childbearing potential and any of the following is true: 1. is pregnant or lactating/breastfeeding, or 2. is not surgically sterile, not post-menopausal (no menses for the previous 12 months), or not practicing an effective method of birth control as determined by the Investigator (eg, oral contraceptives, double barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or partner with vasectomy) - Meet any other exclusion criteria outlined in the Clinical Study Protocol.

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm	Description	Assigned Intervention
Experimental K-321	K-321 ophthalmic solution four times daily (QID) for 12 weeks followed by a two-week gradual dose taper phase and 38-week follow-up phase	Drug: Ripasudil K-321 ophthalmic solution Other names: K-321
Placebo Comparator Placebo	Placebo ophthalmic solution QID for 12 weeks followed by a two-week gradual dose taper phase and 38-week follow-up phase	Drug: Placebo Placebo ophthalmic solution

University of Kentucky
Lexington, Kentucky 40508

Director, Clinical Operations
919-433-1621
StudyRecruitment@KowaUS.com