Study to Investigate the Safety and Efficacy of K-321 in Patients With Fuchs Endothelial Corneal Dystrophy (FECD) Following Descemetorhexis
Purpose
The objective of this study is to investigate the effect of K-321 in patients with Fuchs endothelial corneal dystrophy (FECD) after descemetorhexis.
Condition
- Fuchs' Endothelial Corneal Dystrophy
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 clinical study protocol.
Exclusion Criteria
- Has a study eye with a history of cataract surgery within 90 days of Visit 1. - Has a study eye with a history of any previous ocular surgery other than for cataract. - Meet any other exclusion criteria outlined in clinical study protocol.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental K-321 QID |
K-321 Ophthalmic Solution Dose A |
|
Experimental K-321 BID |
K-321 Ophthalmic Solution Dose B |
|
Placebo Comparator Placebo |
Vehicle Solution Dose |
|
More Details
- Status
- Completed
- Sponsor
- Kowa Research Institute, Inc.