A Double-Masked, Randomized, Placebo-Controlled, Parallel-Group, 12-Week Administration With Two-Week Gradual Dose Taper and 38-Week Follow-Up Phase, Phase 3 Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Simultaneous Cataract Surgery and Descemetorhexis in Subjects With Fuchs Endothelial Corneal Dystrophy (FECD)
- Sponsor: Kowa Research Institute, Inc.
- Principal Investigator: Evan Warner
- Study Coordinator: Chris Smith
Study Objective:
To assess the safety and efficacy of K-321 in participants with Fuchs endothelial corneal dystrophy after simultaneous cataract surgery and descemetorhexis.
Study Design:
The study is divided into two phases. The first period is a 12-week treatment period with QID dosing and eight study visits: randomization and initiation of treatment on Day 1, six interim visits, and one end-of-treatment visit on Week 12. The second period is a 40-week follow-up period, beginning immediately following the Week 12 visit during which study drug frequency will be tapered. A final visit will occur on Week 52.
Inclusion Criteria:
- Subject at least 18 years old at the screening visit (Visit 1)
- Has a diagnosis of Fuchs endothelial corneal dystrophy
Exclusion Criteria:
- Is a female subject of childbearing potential and any of the following is true:
- is pregnant or lactating/breastfeeding, or
- 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)
Contact Chris Smith with questions, (608) 263-7169
For more information about this study, visit clinicaltrials.gov: https://classic.clinicaltrials.gov/ct2/show/NCT05826353?term=KOWA+321-303&draw=2&rank=1