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)

Completed · Phase 3 · Has a placebo group

Conditions studied: Fuchs Endothelial Corneal Dystrophy

In brief

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

Key facts

Study ID

NCT05826353

Run by

Kowa Research Institute, Inc.

People needed

110

Starts

2023-05-11

Expected to finish

2025-10-24

Last updated by the study team

2026-01-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Is a female subject of childbearing potential and any of the following is true:
• is pregnant or lactating/breastfeeding, or
• 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.

Where it is running

• Oftalvist - Barcelona — Barcelona, Spain
• Keck Hospital of USC — Los Angeles, California, United States
• Macy Eye Center — 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
• Bascom Palmer Eye Institute — Palm Beach Gardens, Florida, United States
• Grene Vision Group-Wichita — Wichita, Kansas, United States
• University of Kentucky — Lexington, Kentucky, United States
• W Kellogg Eye Center — Ann Arbor, Michigan, United States
• Verdier Eye Center — Grand Rapids, Michigan, United States
• Vance Thompson Vision - Omaha — Omaha, Nebraska, United States
• Eye Associates of New Mexico - Albuquerque - Northside — Albuquerque, New Mexico, United States
• NYU Langone Health — New York, New York, United States
• Vance Thompson Vision West Fargo — West Fargo, North Dakota, United States
• Cincinnati Eye Institute-1945 Cei Dr — Blue Ash, Ohio, United States
• University Hospitals Cleveland Medical Center - 11100 Euclid Ave — Cleveland, Ohio, United States
• Devers Eye Institute — Portland, Oregon, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Houston Eye Associates — Houston, Texas, United States
• R and R Eye Research, LLC. — San Antonio, Texas, United States
• University of Wisconsin School of Medicine and Public Health — Madison, Wisconsin, United States
• Dr. Greg Moloney — Vancouver, British Columbia, Canada
• Prism Eye Institute - Mississauga-Oakville — Oakville, Ontario, Canada
• Precision Cornea Centre — Ottawa, Ontario, Canada

Full record on ClinicalTrials.gov

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