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)

Fuchs Endothelial Corneal Dystrophy Clinical Trial

Official title:

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 Simultaneous Cataract Surgery and Descemetorhexis in Subjects With Fuchs Endothelial Corneal Dystrophy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05826353
• Other study ID #: K-321-303
• Status: Recruiting
• Phase: Phase 3
• Start date: May 11, 2023
• Est. completion date: January 2025

Study information

• Verified date: April 2024
• Source: Kowa Research Institute, Inc.
• Contact: Director, Clinical Operations
• Phone: 919-433-1621
• Email: StudyRecruitment[@]KowaUS.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Is a female subject 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)

• Meet any other exclusion criteria outlined in the Clinical Study Protocol.

Related Conditions & MeSH terms

• Cataract
• Corneal Dystrophies, Hereditary
• Fuchs Endothelial Corneal Dystrophy
• Fuchs' Endothelial Dystrophy

Intervention

Drug:
• Ripasudil
K-321 ophthalmic solution
• Placebo
Placebo ophthalmic solution

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Universite de Montreal-1000 rue Saint-Denis	Montreal	Quebec
Canada	Prism Eye Institute - Mississauga-Oakville	Oakville	Ontario
Canada	Precision Cornea Centre	Ottawa	Ontario
Canada	University of Ottawa Eye Institute	Ottawa	Ontario
Canada	Dr. Greg Moloney	Vancouver	British Columbia
Denmark	Aarhus Universitetshospital	Aarhus N	Central Jutland
Denmark	Rigshospitalet Glostrup-Valdemar Hansens Vej 1-23	Glostrup	Capital
Germany	Universitatsklinikum Dusseldorf	Düsseldorf	Nordrhein-Westfalen
Germany	Universitatsklinkum Erlangen-Ulmenweg 18	Erlangen	Bayern
Germany	Universitätsklinikum Heidelberg	Heidelberg	Baden-Württemberg
Germany	Universität des Saarlandes	Homburg	Saarland
Germany	Uniklinik Köln	Köln	Nordrhein-Westfalen
Germany	LMU Klinikum der Universität	Muenchen
Germany	Universitätsklinikum Tübingen	Tübingen	Baden-Württemberg
Spain	Hospital Universitario Germans Trias i Pujol	Badalona	Barcelona
Spain	Institut Catala de Retina (ICR)	Barcelona
Spain	Instituto de Microcirugia Ocular	Barcelona
Spain	Oftalvist - Barcelona	Barcelona
Spain	Hospital Arruzafa	Cordoba	Córdoba
Spain	Althaia Xarxa Assistencial Universitaria Manresa	Manresa	Barcelona
Spain	Instituto Oftalmologico Fernandez Vega	Oviedo	Asturias
United Kingdom	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 States	Eye Associates of New Mexico - Albuquerque - Northside	Albuquerque	New Mexico
United States	W Kellogg Eye Center	Ann Arbor	Michigan
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	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Gorovoy MD Eye Specialists	Fort Myers	Florida
United States	UF Health Eye Center - The Oaks	Gainesville	Florida
United States	Verdier Eye Center	Grand Rapids	Michigan
United States	Houston Eye Associates	Houston	Texas
United States	University of Kentucky	Lexington	Kentucky
United States	Keck Hospital of USC	Los Angeles	California
United States	Macy Eye Center	Los Angeles	California
United States	University of Wisconsin School of Medicine and Public Health	Madison	Wisconsin
United States	NYU Langone Health	New York	New York
United States	Vance Thompson Vision - Omaha	Omaha	Nebraska
United States	Bascom Palmer Eye Institute	Palm Beach Gardens	Florida
United States	Byers Eye Institute at Stanford	Palo Alto	California
United States	Devers Eye Institute	Portland	Oregon
United States	Sacramento Eye Consultants	Sacramento	California
United States	R and R Eye Research, LLC.	San Antonio	Texas
United States	Cornea Consultants of Albany	Slingerlands	New York
United States	Vance Thompson Vision West Fargo	W. Fargo	North Dakota
United States	Grene Vision Group-Wichita	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Kowa Research Institute, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  Germany,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks		Baseline to Week 12
Secondary	Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks		Baseline to Week 12
Secondary	Time to achievement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks		Baseline to Week 12
Secondary	Central corneal Endothelial Cell Density (ECD) (cells/mm2) at Week 12	Central corneal endothelial cell images will be captured by non-contact specular microscopy.	Week 12