Print

Purpose

A study to assess the safety and efficacy of K-321 in participants with 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 - 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: 1. is pregnant or lactating/breastfeeding, or 2. 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

Study Design

Phase
Phase 3
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 		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
    K-321 ophthalmic solution
    Other names:
    • K-321
Placebo Comparator
Placebo 		Placebo ophthalmic solution QID for 12 weeks followed by a two-week gradual dose taper phase and 38-week follow-up phase
  • Drug: Placebo
    Placebo ophthalmic solution

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40508

More Details

NCT ID
NCT05795699
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.