This study is in progress, not accepting new patients

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 on Fuchs Endothelial Corneal Dystrophy Fuchs' Dystrophy

Eligibility: for people ages 18 years and up (full criteria)
Location: at UCLA
Dates: study started March 2023
completion around March 2026
Principal Investigator: by Sophie X. Deng, MD, PhD (ucla)

Sophie X. Deng

Description

Summary

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

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

Keywords

Fuchs Endothelial Corneal Dystrophy, Hereditary Corneal Dystrophies, Fuchs' Endothelial Dystrophy, Ripasudil

Eligibility

You can join if…

Open to people ages 18 years and up

Is at least 18 years old at the screening visit (Visit 1)
Has a diagnosis of FECD at Visit 1
Meets all other inclusion criteria outlined in clinical study protocol

You CAN'T join if...

Is a female patient of childbearing potential and any of the following is true:
1. is pregnant or lactating/breastfeeding, or
2. is not surgically sterile, not post-menopausal (no menses for the previous 12 months), or not practicing an effective method of birth control as determined by the Investigator (eg, oral contraceptives, double barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or partner with vasectomy)
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

Locations

Jules Stein Eye Institute
Los Angeles California 90095 United States
Macy Eye Center
Los Angeles California 90048 United States
Keck Hospital of USC
Los Angeles California 90033 United States
Sacramento Eye Consultants
Sacramento California 95815 United States
Byers Eye Institute at Stanford
Palo Alto California 94303 United States

Lead Scientist at University of California Health

Sophie X. Deng, MD, PhD (ucla)
Sophie X. Deng, M.D., Ph.D., holds the Walton Li Chair in Cornea and Uveitis. She previously held the Joan and Jerome Snyder Chair in Cornea Diseases from 7/1/2019-6/30/2023.

Details

Status: in progress, not accepting new patients
Start Date: March 2023
Completion Date: March 2026 (estimated)
Sponsor: Kowa Research Institute, Inc.
ID: NCT05795699
Phase: Phase 3 research study
Study Type: Interventional
Participants: About 107 people participating
Last Updated: February 28, 2025