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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 Descemetorhexis in Subjects with Fuchs Endothelial Corneal Dystrophy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511752-40-00
Acronym
K-321-301
Enrollment
27
Registered
2024-05-28
Start date
2023-05-05
Completion date
Unknown
Last updated
2025-03-19

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

Time to ≥40 ETDRS letter improvement in BCVA during the first 12 weeks after descemetorhexis.

Detailed description

Key secondary endpoints: • Time to ≥20 ETDRS letter improvement during the first 12 weeks after descemetorhexis. • Time to achievement of ≥70 ETDRS letters during the first 12 weeks after descemetorhexis. • Central corneal ECD change from baseline at Week 12. • Time to achievement of no corneal edema in both areas (epithelial, stromal) during the first 12 weeks after descemetorhexis. • Time to exceed pre-DSO ETDRS letter score in BCVA during the first 12 weeks after descemetorhexis.

Interventions

DRUGA matching sterile product (Placebo Ophthalmic Solution) will be provided using the same excipient formulation as the active K-321 product.
DRUGRipasudil

Sponsors

Kowa Research Institute Inc.
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Time to ≥40 ETDRS letter improvement in BCVA during the first 12 weeks after descemetorhexis.—

Secondary

MeasureTime frame
Key secondary endpoints: • Time to ≥20 ETDRS letter improvement during the first 12 weeks after descemetorhexis. • Time to achievement of ≥70 ETDRS letters during the first 12 weeks after descemetorhexis. • Central corneal ECD change from baseline at Week 12. • Time to achievement of no corneal edema in both areas (epithelial, stromal) during the first 12 weeks after descemetorhexis. • Time to exceed pre-DSO ETDRS letter score in BCVA during the first 12 weeks after descemetorhexis.—

Countries

Denmark, Germany, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026