CompletedPhase 3

A Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Cataract Surgery

United States331 participantsStarted 2022-08-04

Plain-language summary

The purpose of this study is to assess the safety and efficacy of K-321 in subjects after cataract surgery

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. is pregnant or lactating/breastfeeding, or
✕. has experienced menarche and is not surgically sterile, not post-menopausal (no menses for the previous 12 months), or not willing to practice an effective method of birth control during the study period as determined by the Investigator (eg, oral contraceptives, double barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or partner with vasectomy).
✕. has a positive urine pregnancy test result at Visit 2 before cataract surgery.

Change in Central Corneal Endothelial Cell Density (ECD) at Week 12

Timeframe: Baseline to Week 12

NCT IDNCT05528172

SponsorKowa Research Institute, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-06-22