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

ArmDescriptionAssigned Intervention
Experimental
K-321 QID
K-321 Ophthalmic Solution Dose A
  • Drug: K-321 Solution
    K-321 solution drops
Experimental
K-321 BID
K-321 Ophthalmic Solution Dose B
  • Drug: K-321 Solution
    K-321 solution drops
  • Drug: Placebo Solution
    Placebo solution drops for K-321
Placebo Comparator
Placebo
Vehicle Solution Dose
  • Drug: Placebo Solution
    Placebo solution drops for K-321

Recruiting Locations

Boston Medical Center
Boston, Massachusetts 02118

More Details

Status
Recruiting
Sponsor
Kowa Research Institute, Inc.

Study Contact

Director, Clinical Operations
919-433-1600
Clinical@KowaUS.com