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A study to assess the safety and efficacy of K-321 in participants with FECD after descemetorhexis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| K-321 | Experimental | 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 | Placebo Comparator | Placebo ophthalmic solution QID for 12 weeks followed by a two-week gradual dose taper phase and 38-week follow-up phase |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ripasudil | Drug | K-321 ophthalmic solution |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Is a female patient of childbearing potential and any of the following is true:
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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| Name | Affiliation | Role |
|---|---|---|
| Shona Pendse, MD, MMSc | Kowa Pharma Development Co. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keck Hospital of USC | Los Angeles | California | 90033 | United States | ||
| Macy Eye Center |
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| Placebo | Drug | Placebo ophthalmic solution |
|
| Baseline to Week 12 |
| Central corneal ECD at Week 12 | Central corneal endothelial cell images will be captured by non-contact specular microscopy. | Week 12 |
| 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 |
| Los Angeles |
| California |
| 90048 |
| United States |
| Jules Stein Eye Institute | Los Angeles | California | 90095 | United States |
| Byers Eye Institute at Stanford | Palo Alto | California | 94303 | United States |
| Sacramento Eye Consultants | Sacramento | California | 95815 | United States |
| Gorovoy MD Eye Specialists | Fort Myers | Florida | 33907 | United States |
| University of Florida | Gainesville | Florida | 32605 | United States |
| Bascom Palmer Eye Institute | Miami | Florida | 33418 | United States |
| Bascom Palmer Eye Institute - Naples | Naples | Florida | 34103 | United States |
| Eye Consultants of Atlanta | Atlanta | Georgia | 30339-5971 | United States |
| Grene Vision Group | Wichita | Kansas | 67208-3648 | United States |
| University of Kentucky | Lexington | Kentucky | 40508 | United States |
| Massachusetts Eye and Ear Infirmary | Boston | Massachusetts | 02114 | United States |
| W Kellogg Eye Center | Ann Arbor | Michigan | 48105 | United States |
| Verdier Eye Center | Grand Rapids | Michigan | 49546 | United States |
| Vance Thompson Vision - Omaha | Omaha | Nebraska | 68137 | United States |
| Eye Associates of New Mexico | Albuquerque | New Mexico | 87109 | United States |
| NYU Langone Health | New York | New York | 10017 | United States |
| Vance Thompson Vision West Fargo | West Fargo | North Dakota | 58078 | United States |
| University Hospitals Cleveland Medical Center - 11100 Euclid Ave | Cleveland | Ohio | 44106 | United States |
| Devers Eye Institute | Portland | Oregon | 97210 | United States |
| Casey Eye Institute - OHSU | Portland | Oregon | 97239 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Houston Eye Associates | Houston | Texas | 77025 | United States |
| R and R Eye Research, LLC. | San Antonio | Texas | 78229 | United States |
| University of Wisconsin - 2870 University Ave | Madison | Wisconsin | 53705 | United States |
| Dr. Greg Moloney | Vancouver | British Columbia | V5Z 1K1 | Canada |
| Prism Eye Institute - Mississauga-Oakville | Oakville | Ontario | L6H 0J8 | Canada |
| Precision Cornea Centre | Ottawa | Ontario | K1G 5L1 | Canada |
| Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| Rigshospitalet Glostrup-Nordre Ringvej 57 | Glostrup Municipality | Capital | 2600 | Denmark |
| Aarhus Universitetshospital | Aarhus N | Central Jutland | 8200 | Denmark |
| Universitätsklinikum Heidelberg | Heidelberg | Baden-Wurttemberg | 69120 | Germany |
| Universitätsklinikum Tübingen | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Universitatsklinkum Erlangen-Ulmenweg 18 | Erlangen | Bavaria | 91054 | Germany |
| Uniklinik Köln | Cologne | North Rhine-Westphalia | 50931 | Germany |
| Universitatsklinikum Dusseldorf | Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
| Universität des Saarlandes | Homburg | Saarland | 66424 | Germany |
| Universitatsklinikum Leipzig | Leipzig | Saxony | 04103 | Germany |
| LMU Klinikum der Universität | München | 81377 | Germany |
| Hospital Universitario Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Althaia Xarxa Assistencial Universitaria Manresa | Manresa | Barcelona | 08243 | Spain |
| Hospital Arruzafa | Córdoba | Córdoba | 14012 | Spain |
| Instituto Oftalmologico Fernandez Vega | Oviedo | Principality of Asturias | 33012 | Spain |
| Oftalvist - Barcelona | Barcelona | 08017 | Spain |
| Institut Catala de Retina (ICR) | Barcelona | 08022 | Spain |
| Instituto de Microcirugia Ocular | Barcelona | 08035 | Spain |
| The Royal Liverpool University Hospital | Liverpool | Lancashire | L7 8XP | United Kingdom |
| Moorfields Eye Hospital | London | London, City of | EC1V 2PD | United Kingdom |
| Royal Victoria Infirmary | Newcastle upon Tyne | Northumberland | NE1 4LP | United Kingdom |
| ID | Term |
|---|---|
| D005642 | Fuchs' Endothelial Dystrophy |
| ID | Term |
|---|---|
| D003317 | Corneal Dystrophies, Hereditary |
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D015785 | Eye Diseases, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| C584679 | K-115 |
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