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NCT05795699 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety and Efficacy of K-321 Eye Drops After Descemetorhexis in Participants With Fuchs Endothelial Corneal Dystrophy (FECD)
A Phase 3 study of Fuchs Endothelial Corneal Dystrophy, sponsored by Kowa Research Institute.
- Completed
- Registry status
- Phase 3
- Development phase
- 107
- Enrollment target
- 20
- Study locations
NCT05795699: Completed Phase 3 study of Fuchs Endothelial Corneal Dystrophy, sponsored by Kowa Research Institute.
NCT05795699 is a Phase 3 study of Fuchs Endothelial Corneal Dystrophy that has completed, run by Kowa Research Institute. The registered enrollment target is 107 participants, above the 32-participant average among 3 other Fuchs Endothelial Corneal Dystrophy trials with a reported enrollment target (234% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05795699, a Phase 3 study of Fuchs Endothelial Corneal Dystrophy, has completed, sponsored by Kowa Research Institute.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 107 participants
- Enrollment target
- 20
- Study locations
Study Summary
A study to assess the safety and efficacy of K-321 in participants with FECD after descemetorhexis.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ripasudil
Study Locations (20)
California
- Keck Hospital of USC - Los Angeles
- Macy Eye Center - Los Angeles
- Jules Stein Eye Institute - Los Angeles
- Byers Eye Institute at Stanford - Palo Alto
- Sacramento Eye Consultants - Sacramento
Florida
- Gorovoy MD Eye Specialists - Fort Myers
- University of Florida - Gainesville
- Bascom Palmer Eye Institute - Miami
- Bascom Palmer Eye Institute - Naples - Naples
Michigan
- W Kellogg Eye Center - Ann Arbor
- Verdier Eye Center - Grand Rapids
Georgia
- Eye Consultants of Atlanta - Atlanta
Kansas
- Grene Vision Group - Wichita
Kentucky
- University of Kentucky - Lexington
Massachusetts
- Massachusetts Eye and Ear Infirmary - Boston
Nebraska
- Vance Thompson Vision - Omaha - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2023-03-30 |
| Est. Completion | 2026-02-20 |
| Phase | Phase 3 |
What the finished NCT05795699 record still lists
NCT05795699 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, above the 32-participant average among 3 other Fuchs Endothelial Corneal Dystrophy trials with a reported enrollment target (234% higher).
The record links to 1 condition, with Fuchs Endothelial Corneal Dystrophy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05795699 names 20 study sites across 12 states, led by California, Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT05795699 about?
NCT05795699 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of K-321 Eye Drops After Descemetorhexis in Participants With Fuchs Endothelial Corneal Dystrophy (FECD)". A study to assess the safety and efficacy of K-321 in participants with FECD after descemetorhexis.
What is the current status of trial NCT05795699?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 107 participants. The study started on 2023-03-30. Estimated completion is 2026-02-20.
What conditions does trial NCT05795699 study?
This clinical trial studies the following conditions: Fuchs Endothelial Corneal Dystrophy.
What interventions are being tested in trial NCT05795699?
The interventions under investigation include: Placebo (DRUG), Ripasudil (DRUG).
Who is sponsoring clinical trial NCT05795699?
This trial is sponsored by Kowa Research Institute, which has 44 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05795699 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Kansas, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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