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
Status: Active_not_recruiting
Location: See all (50) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
A study to assess the safety and efficacy of K-321 in participants with FECD after descemetorhexis.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Jules Stein Eye Institute
Los Angeles
Keck Hospital of USC
Los Angeles
Macy Eye Center
Los Angeles
Byers Eye Institute at Stanford
Palo Alto
Sacramento Eye Consultants
Sacramento
Florida
Gorovoy MD Eye Specialists
Fort Myers
University of Florida
Gainesville
Bascom Palmer Eye Institute
Miami
Bascom Palmer Eye Institute - Naples
Naples
Georgia
Eye Consultants of Atlanta
Atlanta
Kansas
Grene Vision Group
Wichita
Kentucky
University of Kentucky
Lexington
Massachusetts
Massachusetts Eye and Ear Infirmary
Boston
Michigan
W Kellogg Eye Center
Ann Arbor
Verdier Eye Center
Grand Rapids
North Dakota
Vance Thompson Vision West Fargo
West Fargo
Nebraska
Vance Thompson Vision - Omaha
Omaha
New Mexico
Eye Associates of New Mexico
Albuquerque
New York
NYU Langone Health
New York
Ohio
University Hospitals Cleveland Medical Center - 11100 Euclid Ave
Cleveland
Oregon
Casey Eye Institute - OHSU
Portland
Devers Eye Institute
Portland
Texas
University of Texas Southwestern Medical Center
Dallas
Houston Eye Associates
Houston
R and R Eye Research, LLC.
San Antonio
Wisconsin
University of Wisconsin - 2870 University Ave
Madison
Other Locations
Canada
Prism Eye Institute - Mississauga-Oakville
Oakville
Ottawa Hospital
Ottawa
Precision Cornea Centre
Ottawa
Dr. Greg Moloney
Vancouver
Denmark
Aarhus Universitetshospital
Aarhus N
Rigshospitalet Glostrup-Nordre Ringvej 57
Glostrup Municipality
Germany
Uniklinik Köln
Cologne
Universitatsklinikum Dusseldorf
Düsseldorf
Universitatsklinkum Erlangen-Ulmenweg 18
Erlangen
Universitätsklinikum Heidelberg
Heidelberg
Universität des Saarlandes
Homburg
Universitatsklinikum Leipzig
Leipzig
LMU Klinikum der Universität
München
Universitätsklinikum Tübingen
Tübingen
Spain
Hospital Universitario Germans Trias i Pujol
Badalona
Institut Catala de Retina (ICR)
Barcelona
Instituto de Microcirugia Ocular
Barcelona
Oftalvist - Barcelona
Barcelona
Hospital Arruzafa
Córdoba
Althaia Xarxa Assistencial Universitaria Manresa
Manresa
Instituto Oftalmologico Fernandez Vega
Oviedo
United Kingdom
The Royal Liverpool University Hospital
Liverpool
Moorfields Eye Hospital
London
Royal Victoria Infirmary
Newcastle Upon Tyne
Time Frame
Start Date: 2023-03-30
Completion Date: 2026-03
Participants
Target number of participants: 107
Treatments
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
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
Related Therapeutic Areas
Sponsors
Leads: Kowa Research Institute, Inc.