A Study to Investigate the Safety and Efficacy of K-321 Eye Drops After Simultaneous Cataract Surgery and Descemetorhexis in Participants With Fuchs Endothelial Corneal Dystrophy (FECD)
Sponsored by Kowa Research Institute, Inc.
About this trial
Last updated 2 years ago
Study ID
K-321-303
Status
Recruiting
Type
Interventional
Phase
Phase 3
Placebo
Yes
Accepting
18+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 6 months ago
What is this trial about?
A study to assess the safety and efficacy of K-321 in participants with FECD after
simultaneous cataract surgery and descemetorhexis.
What are the participation requirements?
Inclusion Criteria
- Is at least 18 years old at the screening visit (Visit 1)
- Has a diagnosis of FECD at Visit 1
- Meet all other inclusion criteria outlined in the Clinical Study Protocol.
Exclusion Criteria
- Is a female subject 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)
- Meet any other exclusion criteria outlined in the Clinical Study Protocol.