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

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

Official Title
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A Double-Masked, Randomized, Placebo-Controlled, Parallel-Group, 12-Week Administration With Two-Week Gradual Dose Taper Phase and 38-Week Follow-Up Phase, Phase 3 Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Descemetorhexis in Subjects With Fuchs Endothelial Corneal Dystrophy

Conditions
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Fuchs Endothelial Corneal Dystrophy

Intervention / Treatment
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* Drug: Ripasudil
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: K-321<br>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 | Drug: Ripasudil<br>* K-321 ophthalmic solution<br>* Other names: K-321;|
| Placebo Comparator: Placebo<br>Placebo ophthalmic solution QID for 12 weeks followed by a two-week gradual dose taper phase and 38-week follow-up phase | Drug: Placebo<br>* Placebo ophthalmic solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks |  | Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks |  | Baseline to Week 12 | 
| Time to achievement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks |  | Baseline to Week 12 | 
| Central corneal ECD at Week 12 | Central corneal endothelial cell images will be captured by non-contact specular microscopy. | Week 12 |