A Study to Evaluate the Safety and Efficacy of K-321 Eye Drops After Descemetorhexis in Participants With Fuchs Endothelial Corneal Dystrophy (FECD)

Phase 3

Recruiting

• Conditions: Fuchs Endothelial Corneal Dystrophy
• Interventions: Drug: Placebo; Drug: Ripasudil

• Registration Number: NCT05795699
• Lead Sponsor: Kowa Research Institute, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-21
• Study First Submitted QC: 2023-03-21
• Study Start: 2023-03-30
• Study First Posted: 2023-04-03
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-25
• Last Update Posted: 2024-10-29
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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

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Exclusion Criteria

• Is a female patient 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)

• Has a study eye with a history of cataract surgery within 90 days of Visit 1

• Meet any other exclusion criteria outlined in clinical study protocol

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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 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 ECD 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
Time to exceed in BCVA pre-DSO ETDRS letter score during the first 12 weeks	Baseline to Week 12

Trial Locations

Locations (47)

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

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, New Mexico, United States

NYU Langone Health; 🇺🇸 New York, New York, United States

Vance Thompson Vision West Fargo; 🇺🇸 W. 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, 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

Universitatsklinikum Leipzig; 🇩🇪 Leipzig, Sachsen, 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, Northumberland, United Kingdom