Study to Investigate the Safety and Efficacy of K-321 in Patients With Fuchs Endothelial Corneal Dystrophy (FECD) Following Descemetorhexis

Phase 2CompletedNCT04250207

Kowa Research Institute, Inc.65 enrolled

Overview

The objective of this study is to investigate the effect of K-321 in patients with Fuchs endothelial corneal dystrophy (FECD) after descemetorhexis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

65

Conditions

Fuchs' Endothelial Corneal Dystrophy

Interventions

K-321 SolutionDRUG

K-321 solution drops

Placebo SolutionDRUG

Placebo solution drops for K-321

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (29)

Outcomes

Primary Outcomes

Central Corneal Endothelial Cell Density (ECD) at Week 12

Change in Central ECD at week 12

Time frame: Baseline to Week 12

Secondary Outcomes

Central Corneal ECD From Baseline to Each Subsequent Visit

Time frame: Baseline to Week 52

Change From Baseline in Central Corneal Thickness

Time frame: Baseline to Week 52

Time to Achievement of no Corneal Oedema of Study Eye

Time frame: Baseline to Week 52

Proportion of Patients Who Achieved Central Corneal ECD of 700 Cells/mm2 or More at Each Visit

Time frame: Baseline to Week 52

Time to Achieve Central Corneal ECD 700 Cells/mm2 or More

Time frame: Up to 52 Weeks

Number of Patients Who Achieved Corneal Thickness Less Than or Equal to Baseline Corneal Thickness

Time frame: Baseline up to 52 Weeks

Proportion of Patients Who Achieve No Corneal Oedema of Study Eye by Visit

Time frame: Baseline to Week 52

Time to Return of Corneal Thickness to Less Than or Equal to Baseline Cornea Thickness

Time frame: Baseline up to Week 52

Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit

Time frame: Baseline to Week 52

Data from ClinicalTrials.gov

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NCT04250207 - Study to Investigate the Safety and Efficacy of K-321 in Patients With Fuchs Endothelial Corneal Dystrophy (FECD) Following Descemetorhexis | Crick | Crick