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
About this trial
This is an interventional treatment trial for Fuchs Endothelial Corneal Dystrophy
Eligibility 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: 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) 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
Sites / Locations
- Sacramento Eye Consultants
- Gorovoy MD Eye Specialists
- Verdier Eye Center
- Tauber Eye CenterRecruiting
- NYU Langone Health
- Cornea Consultants of Albany
- Devers Eye InstituteRecruiting
- Ophthalmic Partners
- Aarhus Universitetshospital
- Instituto Oftalmologico Fernandez Vega
- Hospital Universitario Germans Trias i Pujol
- Althaia Xarxa Assistencial de Manresa
- Instituto de Microcirugia Ocular
- Hospital La ArruzafaRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
K-321
Placebo
K-321 ophthalmic solution four times daily (QID) for 12 weeks followed by a two-week gradual dose taper phase and 38-week follow-up phase
Placebo ophthalmic solution QID for 12 weeks followed by a two-week gradual dose taper phase and 38-week follow-up phase