UK Center for Clinical and Translational Science

A Study to Evaluate the Safety and Efficacy of K-321 Eye Drops After 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 descemetorhexis.

Is at least 18 years old at the screening visit (Visit 1) - Has a diagnosis of FECD at Visit 1 - Meets all other inclusion criteria outlined in clinical study protocol

Is a female patient 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) - Has a study eye with a history of cataract surgery within 90 days of Visit 1 - Meet any other exclusion criteria outlined in 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

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Clinical@KowaUS.com