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 UCLA
Dates
study started
completion around

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

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kowa Research Institute, Inc.
ID
NCT05795699
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 100 study participants
Last Updated