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Kowa Fuchs Endothelial Corneal Dystrophy Study K-321-303

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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

  • Sex: Any
  • Age: Adult (18 - 64), Older Adult (65+)
  • Accepting Healthy People: No
  • Type: Interventional / Therapeutic
  • Trial Phase: Phase III
  • Conditions Being Studied:

Study Purpose

The purpose of this study is for those that have Fuchs Endothelial Corneal Dystrophy (FECD) and are planning to have cataract surgery and a procedure called descemetorhexis. The main goal of this study is to find out the effect of K-321 on how long it takes for your eyesight to improve during the first 12 weeks after cataract surgery and descemetorhexis.

Who Can Participate

Age: 18 years and older

Principal Investigator
Ahmed Omar MD
Department/Division
Ophthalmology (Contact Lens/Cornea)

Locations

UH Landerbrook Health Center
5850 Landerbrook Drive
Mayfield Heights OH, 44124

UH Cleveland Medical Center
11100 Euclid Avenue
Cleveland OH, 44106

UH Westlake Health Center
960 Clague Road
Westlake OH, 44145

  • UH IRB: STUDY20230916
  • StudyID: 2023-01180
  • ClinicalTrials.gov: NCT05826353
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