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

Last updated: June 20, 2025
Sponsor: Kowa Research Institute, Inc.
Overall Status: Active - Not Recruiting

Phase

3

Condition

N/A

Treatment

Ripasudil

Placebo

Clinical Study ID

NCT05795699
K-321-301
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion

Exclusion Criteria:

  • 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 12months), or not practicing an effective method of birth control as determinedby the Investigator (eg, oral contraceptives, double barrier methods, hormonalinjectable or implanted contraceptives, tubal ligation, or partner withvasectomy)

  • 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

Study Design

Total Participants: 107
Treatment Group(s): 2
Primary Treatment: Ripasudil
Phase: 3
Study Start date:
March 30, 2023
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • Dr. Greg Moloney

    Vancouver, British Columbia V5Z 1K1
    Canada

    Site Not Available

  • Prism Eye Institute - Mississauga-Oakville

    Oakville, Ontario L6H 0J8
    Canada

    Site Not Available

  • Ottawa Hospital

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Precision Cornea Centre

    Ottawa, Ontario K1G 5L1
    Canada

    Site Not Available

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec H2X 0C1
    Canada

    Site Not Available

  • Hopital Maisonneuve-Rosemont (HMR)

    Montreal, Quebec H1T 2M4
    Canada

    Site Not Available

  • Rigshospitalet Glostrup-Nordre Ringvej 57

    Glostrup, Capital 2600
    Denmark

    Site Not Available

  • Aarhus Universitetshospital

    Aarhus, Central Jutland 8200
    Denmark

    Site Not Available

  • Aarhus Universitetshospital

    Aarhus N, Central Jutland 8200
    Denmark

    Site Not Available

  • Universitätsklinikum Heidelberg

    Heidelberg, Baden-Württemberg 69120
    Germany

    Site Not Available

  • Universitätsklinikum Tübingen

    Tübingen, Baden-Württemberg 72076
    Germany

    Site Not Available

  • Universitatsklinkum Erlangen-Ulmenweg 18

    Erlangen, Bayern 91054
    Germany

    Site Not Available

  • Universitatsklinikum Dusseldorf

    Düsseldorf, Nordrhein-Westfalen 40225
    Germany

    Site Not Available

  • Uniklinik Köln

    Köln, Nordrhein-Westfalen 50931
    Germany

    Site Not Available

  • Universität des Saarlandes

    Homburg, Saarland 66424
    Germany

    Site Not Available

  • Universitatsklinikum Leipzig

    Leipzig, Sachsen 04103
    Germany

    Site Not Available

  • LMU Klinikum der Universität

    Muenchen, 81377
    Germany

    Site Not Available

  • Instituto Oftalmologico Fernandez Vega

    Oviedo, Asturias 33012
    Spain

    Site Not Available

  • Hospital Universitario Germans Trias i Pujol

    Badalona, Barcelona 08916
    Spain

    Site Not Available

  • Althaia Xarxa Assistencial Universitaria Manresa

    Manresa, Barcelona 08243
    Spain

    Site Not Available

  • Althaia Xarxa Assistencial de Manresa

    Manresa, Barcelona 8243
    Spain

    Site Not Available

  • Hospital Arruzafa

    Cordoba, Córdoba 14012
    Spain

    Site Not Available

  • Institut Catala de Retina (ICR)

    Barcelona, 08022
    Spain

    Site Not Available

  • Instituto de Microcirugia Ocular

    Barcelona, 08035
    Spain

    Site Not Available

  • Oftalvist - Barcelona

    Barcelona, 08017
    Spain

    Site Not Available

  • Hospital La Arruzafa

    Córdoba, 14012
    Spain

    Site Not Available

  • The Royal Liverpool University Hospital

    Liverpool, Lancashire L7 8XP
    United Kingdom

    Site Not Available

  • Moorfields Eye Hospital

    London, London, City Of EC1V 2PD
    United Kingdom

    Site Not Available

  • Royal Victoria Infirmary

    Newcastle Upon Tyne, Northumberland NE1 4LP
    United Kingdom

    Site Not Available

  • Jules Stein Eye Institute

    Los Angeles, California 90095
    United States

    Site Not Available

  • Keck Hospital of USC

    Los Angeles, California 90033
    United States

    Site Not Available

  • Macy Eye Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Byers Eye Institute at Stanford

    Palo Alto, California 94303
    United States

    Site Not Available

  • Sacramento Eye Consultants

    Sacramento, California 95815
    United States

    Site Not Available

  • Gorovoy MD Eye Specialists

    Fort Myers, Florida 33907
    United States

    Site Not Available

  • University of Florida

    Gainesville, Florida 32605
    United States

    Site Not Available

  • Bascom Palmer Eye Institute

    Miami, Florida 33418
    United States

    Site Not Available

  • Bascom Palmer Eye Institute - Naples

    Naples, Florida 34103
    United States

    Site Not Available

  • Eye Consultants of Atlanta

    Atlanta, Georgia 30339-5971
    United States

    Site Not Available

  • Grene Vision Group

    Wichita, Kansas 67208-3648
    United States

    Site Not Available

  • University of Kentucky

    Lexington, Kentucky 40508
    United States

    Site Not Available

  • Massachusetts Eye and Ear Infirmary

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • W Kellogg Eye Center

    Ann Arbor, Michigan 48105
    United States

    Site Not Available

  • Verdier Eye Center

    Grand Rapids, Michigan 49546
    United States

    Site Not Available

  • Tauber Eye Center

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Vance Thompson Vision - Omaha

    Omaha, Nebraska 68137
    United States

    Site Not Available

  • Eye Associates of New Mexico

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • NYU Langone Health

    New York, New York 10017
    United States

    Site Not Available

  • Cornea Consultants of Albany

    Slingerlands, New York 12159
    United States

    Site Not Available

  • Vance Thompson Vision West Fargo

    W. Fargo, North Dakota 58078
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center - 11100 Euclid Ave

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Casey Eye Institute - OHSU

    Portland, Oregon 97239
    United States

    Site Not Available

  • Devers Eye Institute

    Portland, Oregon 97210
    United States

    Site Not Available

  • Ophthalmic Partners

    Bala-Cynwyd, Pennsylvania 19004
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • Houston Eye Associates

    Houston, Texas 77025
    United States

    Site Not Available

  • R and R Eye Research, LLC.

    San Antonio, Texas 78229
    United States

    Site Not Available

  • University of Wisconsin - 2870 University Ave

    Madison, Wisconsin 53705
    United States

    Site Not Available

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