Clinical trial NCT05826353: 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)
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Fuchs Endothelial Corneal Dystrophy
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-24
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks
timeFrame: Baseline to Week 12
measure: Time to achievement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks
timeFrame: Baseline to Week 12
measure: Central corneal Endothelial Cell Density (ECD) (cells/mm2) at Week 12
timeFrame: Week 12
measure: Time to achievement of no corneal edema during the first 12 weeks
timeFrame: Baseline to Week 12
measure: Time to exceed in BCVA pre-DSO ETDRS letter score during the first 12 weeks
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
city: Los Angeles
country: United States
facility: Macy Eye Center
state: California
city: Palo Alto
country: United States
facility: Byers Eye Institute at Stanford
state: California
city: Sacramento
country: United States
facility: Sacramento Eye Consultants
state: California
city: Fort Myers
country: United States
facility: Gorovoy MD Eye Specialists
state: Florida
city: Palm Beach Gardens
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
city: Wichita
country: United States
facility: Grene Vision Group-Wichita
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Ann Arbor
country: United States
facility: W Kellogg Eye Center
state: Michigan
city: Grand Rapids
country: United States
facility: Verdier Eye Center
state: Michigan
city: Omaha
country: United States
facility: Vance Thompson Vision - Omaha
state: Nebraska
city: Albuquerque
country: United States
facility: Eye Associates of New Mexico - Albuquerque - Northside
state: New Mexico
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: W. Fargo
country: United States
facility: Vance Thompson Vision West Fargo
state: North Dakota
city: Blue Ash
country: United States
facility: Cincinnati Eye Institute-1945 Cei Dr
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center - 11100 Euclid Ave
state: Ohio
city: Portland
country: United States
facility: Devers Eye Institute
state: Oregon
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: San Antonio
country: United States
facility: R and R Eye Research, LLC.
state: Texas
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health
state: Wisconsin
city: Vancouver
country: Canada
facility: Dr. Greg Moloney
state: British Columbia
city: Oakville
country: Canada
facility: Prism Eye Institute - Mississauga-Oakville
state: Ontario
city: Ottawa
country: Canada
facility: Precision Cornea Centre
state: Ontario
city: Glostrup
country: Denmark
facility: Rigshospitalet Glostrup-Valdemar Hansens Vej 1-23
state: Capital
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital
state: Central Jutland
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
state: Baden-Württemberg
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
state: Baden-Württemberg
city: Erlangen
country: Germany
facility: Universitatsklinkum Erlangen-Ulmenweg 18
state: Bayern
city: Düsseldorf
country: Germany
facility: Universitatsklinikum Dusseldorf
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: Uniklinik Köln
state: Nordrhein-Westfalen
city: Homburg
country: Germany
facility: Universität des Saarlandes
state: Saarland
city: Muenchen
country: Germany
facility: LMU Klinikum der Universität
city: Oviedo
country: Spain
facility: Instituto Oftalmologico Fernandez Vega
state: Asturias
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
state: Barcelona
city: Manresa
country: Spain
facility: Althaia Xarxa Assistencial Universitaria Manresa
state: Barcelona
city: Cordoba
country: Spain
facility: Hospital Arruzafa
state: Córdoba
city: Barcelona
country: Spain
facility: Oftalvist - Barcelona
city: Barcelona
country: Spain
facility: Institut Catala de Retina (ICR)
city: Barcelona
country: Spain
facility: Instituto de Microcirugia Ocular
city: Liverpool
country: United Kingdom
facility: The Royal Liverpool University Hospital
state: Lancashire
city: London
country: United Kingdom
facility: Moorfields Eye Hospital
state: London, City Of
city: Newcastle Upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
state: Tyne And Wear
Study officials:
affiliation: Kowa Pharma Development Co.
name: Shona Pendse, MD, MMSc
role: STUDY_CHAIR
References: