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COMPLETED
NCT05795699
PHASE3

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

Sponsor: Kowa Research Institute, Inc.

View on ClinicalTrials.gov

Summary

A study to assess the safety and efficacy of K-321 in participants with FECD after 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 Descemetorhexis in Subjects With Fuchs Endothelial Corneal Dystrophy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

107

Start Date

2023-03-30

Completion Date

2026-02-20

Last Updated

2026-05-27

Healthy Volunteers

No

Interventions

DRUG

Ripasudil

K-321 ophthalmic solution

DRUG

Placebo

Placebo ophthalmic solution

Locations (50)

Keck Hospital of USC

Los Angeles, California, United States

Macy Eye Center

Los Angeles, California, United States

Jules Stein Eye Institute

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

University of Florida

Gainesville, Florida, United States

Bascom Palmer Eye Institute

Miami, Florida, United States

Bascom Palmer Eye Institute - Naples

Naples, Florida, United States

Eye Consultants of Atlanta

Atlanta, Georgia, United States

Grene Vision Group

Wichita, Kansas, United States

University of Kentucky

Lexington, Kentucky, United States

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 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, New Mexico, United States

NYU Langone Health

New York, New York, United States

Vance Thompson Vision West Fargo

West Fargo, North Dakota, United States

University Hospitals Cleveland Medical Center - 11100 Euclid Ave

Cleveland, Ohio, United States

Devers Eye Institute

Portland, Oregon, United States

Casey Eye Institute - OHSU

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 - 2870 University Ave

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

Ottawa Hospital

Ottawa, Ontario, Canada

Rigshospitalet Glostrup-Nordre Ringvej 57

Glostrup Municipality, Capital, Denmark

Aarhus Universitetshospital

Aarhus N, Central Jutland, Denmark

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, Germany

Universitatsklinkum Erlangen-Ulmenweg 18

Erlangen, Bavaria, Germany

Uniklinik Köln

Cologne, North Rhine-Westphalia, Germany

Universitatsklinikum Dusseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Universität des Saarlandes

Homburg, Saarland, Germany

Universitatsklinikum Leipzig

Leipzig, Saxony, Germany

LMU Klinikum der Universität

München, Germany

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, Spain

Althaia Xarxa Assistencial Universitaria Manresa

Manresa, Barcelona, Spain

Hospital Arruzafa

Córdoba, Córdoba, Spain

Instituto Oftalmologico Fernandez Vega

Oviedo, Principality of Asturias, Spain

Oftalvist - Barcelona

Barcelona, Spain

Institut Catala de Retina (ICR)

Barcelona, Spain

Instituto de Microcirugia Ocular

Barcelona, Spain

The Royal Liverpool University Hospital

Liverpool, Lancashire, United Kingdom

Moorfields Eye Hospital

London, London, City of, United Kingdom

Royal Victoria Infirmary

Newcastle upon Tyne, Northumberland, United Kingdom