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

EU CTIS

Registry ID

CTIS2022-502643-35-00

Acronym

K-321-303

Enrollment

Registered

2023-07-21

Start date

2023-08-09

Completion date

2025-10-17

Last updated

2025-03-21

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 simultaneous cataract surgery and descemetorhexis.

Detailed description

Time to ≥20 ETDRS letter improvement during the first 12 weeks after simultaneous cataract surgery and descemetorhexis., Time to achievement of ≥70 ETDRS letters during the first 12 weeks after simultaneous cataract surgery and descemetorhexis., Central corneal ECD change from baseline at Week 12.

Interventions

DRUGRipasudil

DRUGThe placebo is presented as sterile non-preserved unit dose eye drops that do not contain Ripasudil hydrochloride dihydrate. For the proposed study the eye drops are packaged in 0.3ml quantities in clear additive free polyethylene blow-fill-seal ampoules.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time to ≥40 ETDRS letter improvement in BCVA during the first 12 weeks after simultaneous cataract surgery and descemetorhexis.	—

Secondary

Measure	Time frame
Time to ≥20 ETDRS letter improvement during the first 12 weeks after simultaneous cataract surgery and descemetorhexis., Time to achievement of ≥70 ETDRS letters during the first 12 weeks after simultaneous cataract surgery and descemetorhexis., Central corneal ECD change from baseline at Week 12.	—

Countries

Denmark, Germany, Spain

Outcome results

None listed

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