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Completed

NCT Number: NCT05826353

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)

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

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Key information

Conditions

Fuchs Endothelial Corneal Dystrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Corneal Diseases Corneal Dystrophies, Hereditary Eye Diseases Eye Diseases, Hereditary Fuchs' Endothelial Dystrophy Genetic Diseases, Inborn

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dr. Greg Moloney, Vancouver, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • is pregnant or lactating/breastfeeding, or
  • 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.

Treatment and study plan

Ripasudil

Drug

K-321 ophthalmic solution

Other names: K-321

Placebo

Drug

Placebo ophthalmic solution

Primary outcomes

  1. Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks

    Time frame: Baseline to Week 12

Secondary outcomes

  1. Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks

    Time frame: Baseline to Week 12

  2. Time to achievement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks

    Time frame: Baseline to Week 12

  3. Central corneal Endothelial Cell Density (ECD) (cells/mm2) at Week 12

    Time frame: Week 12

    Central corneal endothelial cell images will be captured by non-contact specular microscopy.

  4. Time to achievement of no corneal edema during the first 12 weeks

    Time frame: Baseline to Week 12

  5. Time to exceed in BCVA pre-DSO ETDRS letter score during the first 12 weeks

    Time frame: Baseline to Week 12

Sponsors and collaborators

Lead sponsor

Kowa Research Institute, Inc.

Industry

Registry information

Official study title

A Double-Masked, Randomized, Placebo-Controlled, Parallel-Group, 12-Week Administration With Two-Week Gradual Dose Taper Phase and 38-Week Follow-Up Phase, Phase 3 Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Simultaneous Cataract Surgery and Descemetorhexis in Subjects With Fuchs Endothelial Corneal Dystrophy

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 24, 2023
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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