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

Fuchs Endothelial Corneal Dystrophy

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

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Participation Requirements

  • Sex:

    ALL
  • Eligible Ages:

    18 and up

Participation Criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Study Location

Prism Eye Institute - Mississauga-Oakville
Prism Eye Institute - Mississauga-Oakville
Oakville, Ontario
Canada

Contact Study Team

Dr. Greg Moloney
Dr. Greg Moloney
Vancouver, British Columbia
Canada

Contact Study Team

Precision Cornea Centre
Precision Cornea Centre
Ottawa, Ontario
Canada

Contact Study Team

Ottawa Hospital
Ottawa Hospital
Ottawa, Ontario
Canada

Contact Study Team

Study Sponsored By
Kowa Research Institute, Inc.
Participants Required
More Information
Study ID: NCT05795699