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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.