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)

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Trial ID: NCT05826353

Age - 18 Years- Gender - ALL Accepting Healthy Volunteers - No

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

Stanford Investigator(s)

Charles C. Lin, MD
Charles C. Lin, MD

Clinical Associate Professor, Ophthalmology

Eligibility

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

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Intervention(s):

drug: Ripasudil

drug: Placebo

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Director, Clinical Operations
919-433-1621

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