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

Phase 3

Active, not recruiting

• Conditions: Fuchs Endothelial Corneal Dystrophy
• Interventions: Drug: Placebo; Drug: Ripasudil

• Registration Number: NCT05826353
• Lead Sponsor: Kowa Research Institute, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-06
• Study First Submitted QC: 2023-04-21
• Study First Posted: 2023-04-24
• Study Start: 2023-05-11
• Primary Completion: 2025-01-17
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-20
• Last Update Posted: 2025-06-22
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 110

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 the Clinical Study Protocol.

Exclusion Criteria

• Is a female subject 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)

• Meet any other exclusion criteria outlined in the Clinical Study Protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo ophthalmic solution QID for 12 weeks followed by a two-week gradual dose taper phase and 38-week follow-up phase
K-321	Ripasudil	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

Primary Outcome Measures

Name	Time	Method
Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks	Baseline to Week 12

Secondary Outcome Measures

Name	Time	Method
Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks	Baseline to Week 12
Time to achievement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks	Baseline to Week 12
Central corneal Endothelial Cell Density (ECD) (cells/mm2) at Week 12	Week 12	Central corneal endothelial cell images will be captured by non-contact specular microscopy.
Time to achievement of no corneal edema during the first 12 weeks	Baseline to Week 12
Time to exceed in BCVA pre-DSO ETDRS letter score during the first 12 weeks	Baseline to Week 12

Trial Locations

Locations (43)

Keck Hospital of USC; 🇺🇸 Los Angeles, California, United States

Macy Eye Center; 🇺🇸 Los Angeles, California, United States

Byers Eye Institute at Stanford; 🇺🇸 Palo Alto, California, United States

Sacramento Eye Consultants; 🇺🇸 Sacramento, California, United States

Gorovoy MD Eye Specialists; 🇺🇸 Fort Myers, Florida, United States

Bascom Palmer Eye Institute; 🇺🇸 Palm Beach Gardens, Florida, United States

Grene Vision Group-Wichita; 🇺🇸 Wichita, Kansas, United States

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

W Kellogg Eye Center; 🇺🇸 Ann Arbor, Michigan, United States

Verdier Eye Center; 🇺🇸 Grand Rapids, Michigan, United States

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