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 DystrophyA study to assess the safety and efficacy of K-321 in participants with FECD after descemetorhexis.
null
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-OakvilleOakville, Ontario
Canada
Contact Study Team
Dr. Greg Moloney
Dr. Greg MoloneyVancouver, British Columbia
Canada
Contact Study Team
Precision Cornea Centre
Precision Cornea CentreOttawa, Ontario
Canada
Contact Study Team
Ottawa Hospital
Ottawa HospitalOttawa, Ontario
Canada
Contact Study Team
- Study Sponsored By
- Kowa Research Institute, Inc.
- Participants Required
- More Information
- Study ID:
NCT05795699