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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT05795699

Public ClinicalTrials.gov record NCT05795699. 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.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 6:55 PM EDT

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 Descemetorhexis in Subjects With Fuchs Endothelial Corneal Dystrophy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT05795699
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Kowa Research Institute, Inc.
Industry
Enrollment
107 participants

Conditions and interventions

Interventions

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
Mar 30, 2023 (Actual)
Primary completion
May 22, 2025 (Actual)
Completion
Feb 20, 2026 (Actual)
Last update posted
May 27, 2026

2023 – 2026

United States locations

U.S. sites
26
U.S. states
15
U.S. cities
23
Facility City State ZIP Site status
Keck Hospital of USC Los Angeles California 90033 —
Macy Eye Center Los Angeles California 90048 —
Jules Stein Eye Institute Los Angeles California 90095 —
Byers Eye Institute at Stanford Palo Alto California 94303 —
Sacramento Eye Consultants Sacramento California 95815 —
Gorovoy MD Eye Specialists Fort Myers Florida 33907 —
University of Florida Gainesville Florida 32605 —
Bascom Palmer Eye Institute Miami Florida 33418 —
Bascom Palmer Eye Institute - Naples Naples Florida 34103 —
Eye Consultants of Atlanta Atlanta Georgia 30339-5971 —
Grene Vision Group Wichita Kansas 67208-3648 —
University of Kentucky Lexington Kentucky 40508 —
Massachusetts Eye and Ear Infirmary Boston Massachusetts 02114 —
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 New Mexico 87109 —
NYU Langone Health New York New York 10017 —
Vance Thompson Vision West Fargo West Fargo North Dakota 58078 —
University Hospitals Cleveland Medical Center - 11100 Euclid Ave Cleveland Ohio 44106 —
Devers Eye Institute Portland Oregon 97210 —
Casey Eye Institute - OHSU Portland Oregon 97239 —
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 - 2870 University Ave 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 24 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05795699, 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 May 27, 2026 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05795699 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →