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

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around
Principal Investigator
by Sophie X. Deng, MD, PhD
Headshot of Sophie X. Deng
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

Lead Scientist at UCLA

  • Sophie X. Deng, MD, PhD
    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
Completion Date
(estimated)
Sponsor
Kowa Research Institute, Inc.
Links
Sign up for this study
ID
NCT05795699
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 107 people participating
Last Updated
Contact us about this trial