A Study to Investigate the Safety and Efficacy of K-321 Eye Drops After Simultaneous Cataract Surgery and Descemetorhexis in Participants With Fuchs Endothelial Corneal Dystrophy (FECD)
- Conditions
- Fuchs Endothelial Corneal Dystrophy
- Interventions
- Drug: PlaceboDrug: Ripasudil
- Registration Number
- NCT05826353
- Lead Sponsor
- Kowa Research Institute, Inc.
- Brief Summary
A study to assess the safety and efficacy of K-321 in participants with FECD after simultaneous cataract surgery and descemetorhexis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 110
- Is at least 18 years old at the screening visit (Visit 1)
- Has a diagnosis of FECD at Visit 1
- Meet all other inclusion criteria outlined in the Clinical Study Protocol.
-
Is a female subject of childbearing potential and any of the following is true:
- is pregnant or lactating/breastfeeding, or
- 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)
-
Meet any other exclusion criteria outlined in the Clinical Study Protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo ophthalmic solution QID for 12 weeks followed by a two-week gradual dose taper phase and 38-week follow-up phase K-321 Ripasudil 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
- Primary Outcome Measures
Name Time Method Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks Baseline to Week 12
- Secondary Outcome Measures
Name Time Method Time to exceed in BCVA pre-DSO ETDRS letter score during the first 12 weeks Baseline to Week 12 Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks Baseline to Week 12 Time to achievement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks Baseline to Week 12 Central corneal Endothelial Cell Density (ECD) (cells/mm2) at Week 12 Week 12 Central corneal endothelial cell images will be captured by non-contact specular microscopy.
Time to achievement of no corneal edema during the first 12 weeks Baseline to Week 12
Trial Locations
- Locations (43)
Keck Hospital of USC
🇺🇸Los Angeles, California, United States
Macy Eye Center
🇺🇸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
Bascom Palmer Eye Institute
🇺🇸Palm Beach Gardens, Florida, United States
Grene Vision Group-Wichita
🇺🇸Wichita, Kansas, United States
University of Kentucky
🇺🇸Lexington, Kentucky, 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 - Northside
🇺🇸Albuquerque, New Mexico, United States
NYU Langone Health
🇺🇸New York, New York, United States
Vance Thompson Vision West Fargo
🇺🇸W. Fargo, North Dakota, United States
Cincinnati Eye Institute-1945 Cei Dr
🇺🇸Blue Ash, Ohio, United States
University Hospitals Cleveland Medical Center - 11100 Euclid Ave
🇺🇸Cleveland, Ohio, United States
Devers Eye Institute
🇺🇸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 School of Medicine and Public Health
🇺🇸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
Rigshospitalet Glostrup-Valdemar Hansens Vej 1-23
🇩🇰Glostrup, Capital, Denmark
Aarhus Universitetshospital
🇩🇰Aarhus N, Central Jutland, Denmark
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Baden-Württemberg, Germany
Universitätsklinikum Tübingen
🇩🇪Tübingen, Baden-Württemberg, Germany
Universitatsklinkum Erlangen-Ulmenweg 18
🇩🇪Erlangen, Bayern, Germany
Universitatsklinikum Dusseldorf
🇩🇪Düsseldorf, Nordrhein-Westfalen, Germany
Uniklinik Köln
🇩🇪Köln, Nordrhein-Westfalen, Germany
Universität des Saarlandes
🇩🇪Homburg, Saarland, Germany
LMU Klinikum der Universität
🇩🇪Muenchen, Germany
Instituto Oftalmologico Fernandez Vega
🇪🇸Oviedo, Asturias, Spain
Hospital Universitario Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Althaia Xarxa Assistencial Universitaria Manresa
🇪🇸Manresa, Barcelona, Spain
Hospital Arruzafa
🇪🇸Cordoba, Córdoba, 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, Tyne And Wear, United Kingdom