A Study to Evaluate the Safety and Efficacy of K-321 Eye Drops After Descemetorhexis in Participants With Fuchs Endothelial Corneal Dystrophy (FECD)
NCT ID: NCT05795699
Last Updated: 2025-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
107 participants
INTERVENTIONAL
2023-03-30
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
Ripasudil
K-321 ophthalmic solution
Placebo
Placebo ophthalmic solution QID for 12 weeks followed by a two-week gradual dose taper phase and 38-week follow-up phase
Placebo
Placebo ophthalmic solution
Interventions
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Ripasudil
K-321 ophthalmic solution
Placebo
Placebo ophthalmic solution
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has a diagnosis of FECD at Visit 1
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Kowa Research Institute, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Shona Pendse, MD, MMSc
Role: STUDY_CHAIR
Kowa Pharma Development Co.
Locations
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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
Countries
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Other Identifiers
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K-321-301
Identifier Type: -
Identifier Source: org_study_id
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