A Study to Evaluate the Safety and Efficacy of K-321 Eye Drops After Descemetorhexis in Participants With Fuchs Endothelial Corneal Dystrophy (FECD)

Kowa

Status and phase: Enrolling; Phase 3

Conditions: Fuchs Endothelial Corneal Dystrophy

Treatments: Drug: Ripasudil; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05795699

K-321-301

Details and patient eligibility

About

A study to assess the safety and efficacy of K-321 in participants with FECD after descemetorhexis.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

K-321

Experimental group

Description:

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

Treatment:

Drug: Ripasudil

Placebo

Placebo Comparator group

Description:

Placebo ophthalmic solution QID for 12 weeks followed by a two-week gradual dose taper phase and 38-week follow-up phase

Treatment:

Drug: Placebo