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)
Public ClinicalTrials.gov record NCT05826353. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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 identification
- NCT ID
- NCT05826353
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Kowa Research Institute, Inc.
- Industry
- Enrollment
- 110 participants
Conditions and interventions
Conditions
Interventions
- Ripasudil Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 10, 2023
- Primary completion
- Jan 16, 2025
- Completion
- Oct 23, 2025
- Last update posted
- Jan 21, 2026
2023 – 2025
United States locations
- U.S. sites
- 21
- U.S. states
- 13
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Keck Hospital of USC | Los Angeles | California | 90033 | — |
| Macy Eye Center | Los Angeles | California | 90048 | — |
| Byers Eye Institute at Stanford | Palo Alto | California | 94303 | — |
| Sacramento Eye Consultants | Sacramento | California | 95815 | — |
| Gorovoy MD Eye Specialists | Fort Myers | Florida | 33907 | — |
| Bascom Palmer Eye Institute | Palm Beach Gardens | Florida | 33136 | — |
| Grene Vision Group-Wichita | Wichita | Kansas | 67208 | — |
| University of Kentucky | Lexington | Kentucky | 40508 | — |
| W Kellogg Eye Center | Ann Arbor | Michigan | 48105 | — |
| Verdier Eye Center | Grand Rapids | Michigan | 49546 | — |
| Vance Thompson Vision - Omaha | Omaha | Nebraska | 68137 | — |
| Eye Associates of New Mexico - Albuquerque - Northside | Albuquerque | New Mexico | 87109 | — |
| NYU Langone Health | New York | New York | 10017 | — |
| Vance Thompson Vision West Fargo | West Fargo | North Dakota | 58078 | — |
| Cincinnati Eye Institute-1945 Cei Dr | Blue Ash | Ohio | 45242 | — |
| University Hospitals Cleveland Medical Center - 11100 Euclid Ave | Cleveland | Ohio | 44106 | — |
| Devers Eye Institute | Portland | Oregon | 97210 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Houston Eye Associates | Houston | Texas | 77025 | — |
| R and R Eye Research, LLC. | San Antonio | Texas | 78229 | — |
| University of Wisconsin School of Medicine and Public Health | Madison | Wisconsin | 53705 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 22 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05826353, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 21, 2026 · Synced Jul 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05826353 live on ClinicalTrials.gov.