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 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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05826353

Enrollment

110

Registered

2023-04-24

Start date

2023-05-11

Completion date

2025-10-24

Last updated

2026-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fuchs Endothelial Corneal Dystrophy

Brief summary

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

Interventions

DRUGRipasudil

K-321 ophthalmic solution

DRUGPlacebo

Placebo ophthalmic solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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	—

Countries

Canada, Denmark, Germany, Spain, United Kingdom, United States

Contacts

STUDY_CHAIRShona Pendse, MD, MMSc

Kowa Pharma Development Co.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026