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

May 21, 2026 updated by: Kowa Research Institute, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1K1
        • Dr. Greg Moloney
    • Ontario
      • Oakville, Ontario, Canada, L6H 0J8
        • Prism Eye Institute - Mississauga-Oakville
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital
      • Ottawa, Ontario, Canada, K1G 5L1
        • Precision Cornea Centre
  • Denmark
    • Capital
      • Glostrup Municipality, Capital, Denmark, 2600
        • Rigshospitalet Glostrup-Nordre Ringvej 57
    • Central Jutland
      • Aarhus N, Central Jutland, Denmark, 8200
        • Aarhus Universitetshospital
  • Germany
      • München, Germany, 81377
        • LMU Klinikum der Universität
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69120
        • Universitatsklinikum Heidelberg
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Universitätsklinikum Tübingen
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Universitatsklinkum Erlangen-Ulmenweg 18
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 50931
        • Uniklinik Köln
      • Düsseldorf, North Rhine-Westphalia, Germany, 40225
        • Universitatsklinikum Dusseldorf
    • Saarland
      • Homburg, Saarland, Germany, 66424
        • Universität des Saarlandes
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • Universitatsklinikum Leipzig
  • Spain
      • Barcelona, Spain, 08035
        • Instituto de Microcirugia Ocular
      • Barcelona, Spain, 08022
        • Institut Catala de Retina (ICR)
      • Barcelona, Spain, 08017
        • Oftalvist - Barcelona
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitario Germans Trias i Pujol
      • Manresa, Barcelona, Spain, 08243
        • Althaia Xarxa Assistencial Universitaria Manresa
    • Córdoba
      • Córdoba, Córdoba, Spain, 14012
        • Hospital Arruzafa
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain, 33012
        • Instituto Oftalmologico Fernandez Vega
  • United Kingdom
    • Lancashire
      • Liverpool, Lancashire, United Kingdom, L7 8XP
        • The Royal Liverpool University Hospital
    • London, City of
      • London, London, City of, United Kingdom, EC1V 2PD
        • Moorfields Eye Hospital
    • Northumberland
      • Newcastle upon Tyne, Northumberland, United Kingdom, NE1 4LP
        • Royal Victoria Infirmary
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Keck Hospital of USC
      • Los Angeles, California, United States, 90095
        • Jules Stein Eye Institute
      • Los Angeles, California, United States, 90048
        • Macy Eye Center
      • Palo Alto, California, United States, 94303
        • Byers Eye Institute at Stanford
      • Sacramento, California, United States, 95815
        • Sacramento Eye Consultants
    • Florida
      • Fort Myers, Florida, United States, 33907
        • Gorovoy MD Eye Specialists
      • Gainesville, Florida, United States, 32605
        • University of Florida
      • Miami, Florida, United States, 33418
        • Bascom Palmer Eye Institute
      • Naples, Florida, United States, 34103
        • Bascom Palmer Eye Institute - Naples
    • Georgia
      • Atlanta, Georgia, United States, 30339-5971
        • Eye Consultants of Atlanta
    • Kansas
      • Wichita, Kansas, United States, 67208-3648
        • Grene Vision Group
    • Kentucky
      • Lexington, Kentucky, United States, 40508
        • University of Kentucky
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts Eye and Ear Infirmary
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • W Kellogg Eye Center
      • Grand Rapids, Michigan, United States, 49546
        • Verdier Eye Center
    • Nebraska
      • Omaha, Nebraska, United States, 68137
        • Vance Thompson Vision - Omaha
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Eye Associates of New Mexico
    • New York
      • New York, New York, United States, 10017
        • NYU Langone Health
    • North Dakota
      • West Fargo, North Dakota, United States, 58078
        • Vance Thompson Vision West Fargo
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center - 11100 Euclid Ave
    • Oregon
      • Portland, Oregon, United States, 97210
        • Devers Eye Institute
      • Portland, Oregon, United States, 97239
        • Casey Eye Institute - OHSU
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Houston, Texas, United States, 77025
        • Houston Eye Associates
      • San Antonio, Texas, United States, 78229
        • R and R Eye Research, LLC.
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin - 2870 University Ave

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks
Time Frame: Baseline to Week 12
Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks
Time Frame: Baseline to Week 12
Baseline to Week 12
Time to achievement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks
Time Frame: Baseline to Week 12
Baseline to Week 12
Central corneal ECD at Week 12
Time Frame: Week 12
Central corneal endothelial cell images will be captured by non-contact specular microscopy.
Week 12
Time to achievement of no corneal edema during the first 12 weeks
Time Frame: Baseline to Week 12
Baseline to Week 12
Time to exceed in BCVA pre-DSO ETDRS letter score during the first 12 weeks
Time Frame: Baseline to Week 12
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kowa Research Institute, Inc.

Investigators

  • Study Chair: Shona Pendse, MD, MMSc, Kowa Pharma Development Co.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2023

Primary Completion (Actual)

May 22, 2025

Study Completion (Actual)

February 20, 2026

Study Registration Dates

First Submitted

March 21, 2023

First Submitted That Met QC Criteria

March 21, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K-321-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fuchs Endothelial Corneal Dystrophy

Clinical Trials on Ripasudil

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe