Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A study to assess the safety and efficacy of K-321 in participants with FECD after simultaneous cataract surgery and descemetorhexis.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Is a female subject of childbearing potential and any of the following is true:
Meet any other exclusion criteria outlined in the Clinical Study Protocol.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo ophthalmic solution |
|
| Baseline to Week 12 |
| 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 |
| 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 |
| 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 |
| Bascom Palmer Eye Institute | Palm Beach Gardens | Florida | 33136 | United States |
| Grene Vision Group-Wichita | Wichita | Kansas | 67208 | United States |
| University of Kentucky | Lexington | Kentucky | 40508 | 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 - Northside | 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 |
| Cincinnati Eye Institute-1945 Cei Dr | Blue Ash | Ohio | 45242 | United States |
| University Hospitals Cleveland Medical Center - 11100 Euclid Ave | Cleveland | Ohio | 44106 | United States |
| Devers Eye Institute | Portland | Oregon | 97210 | 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 School of Medicine and Public Health | Madison | Wisconsin | 53705 | United States |
| Dr. Greg Moloney | Vancouver | British Columbia | 2000 | Canada |
| Prism Eye Institute - Mississauga-Oakville | Oakville | Ontario | L5L 1W8 | Canada |
| Precision Cornea Centre | Ottawa | Ontario | K1G 5L1 | Canada |
| Rigshospitalet Glostrup-Valdemar Hansens Vej 1-23 | Glostrup Municipality | Capital | 2600 | Denmark |
| Aarhus Universitetshospital | Aarhus N | Central Jutland | 8200 | Denmark |
| Universitätsklinikum Heidelberg | Heidelberg | Baden-Wurttemberg | 91054 | 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 |
| LMU Klinikum der Universität | München | 81377 | Germany |
| Hospital Universitario Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Althaia Xarxa Assistencial Universitaria Manresa | Manresa | Barcelona | 17001 | 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 | Tyne and Wear | 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C584679 | K-115 |
Not provided
Not provided
Not provided