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

Completed · Phase 3 · Has a placebo group

Conditions studied: Corneal Edema After Cataract Surgery

In brief

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

Key facts

Study ID

NCT05528172

Run by

Kowa Research Institute, Inc.

People needed

330

Starts

2022-08-04

Expected to finish

2023-06-22

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Is at least 18 years old at the screening visit (Visit 1).
• Is planning to undergo cataract surgery in the study eye and has had cataract surgery at Visit 2.
• Can understand the written informed consent, provides signed written informed consent, and agrees to comply with protocol requirements before any study-specific assessment is performed.
• Meet all other inclusion criteria outlined in clinical study protocol.

You may not qualify if…

• Is a female subject of childbearing potential and any of the following is true:
• 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.
• Had intraocular surgery (non-laser surgery) in the study eye within 6 months of Visit 1.
• Had intraocular laser surgery in the study eye within 3 months of Visit 1.
• Meet any other exclusion criteria outlined in clinical study protocol

Where it is running

• Cornea and Cataract Consultants of Arizona — Phoenix, Arizona, United States
• Schwartz Laser Eye Center — Scottsdale, Arizona, United States
• Inland Eye Specialists — Hemet, California, United States
• United Medical Research Institute — Inglewood, California, United States
• Alvarado Eye Associates — La Mesa, California, United States
• SoCal Eye Physicians and Associates — Long Beach, California, United States
• Visionary Research Institute — Newport Beach, California, United States
• Pendleton Eye Center — Oceanside, California, United States
• North Bay Eye Associates — Petaluma, California, United States
• Martel Eye Medical Group — Rancho Cordova, California, United States
• Premiere Practice Management, LLC — Torrance, California, United States
• Wolstan and Goldberg Eye Associates — Torrance, California, United States
• Icon Eye Care — Grand Junction, Colorado, United States
• Eye Associates of Fort Myers — Fort Myers, Florida, United States
• Levenson Eye Associates — Jacksonville, Florida, United States
• International Research Center — Tampa, Florida, United States
• Clayton Eye Clinical Research, LLC — Morrow, Georgia, United States
• Durrie Vision — Overland Park, Kansas, United States
• Eye Care Institute/Butchertown Clinical Trials — Louisville, Kentucky, United States
• Maine Eye Center — Portland, Maine, United States
• Fraser Eye Care Center — Fraser, Michigan, United States
• Silverstein Eye Centers — Kansas City, Missouri, United States
• Tekwani Vision Center — St Louis, Missouri, United States
• Ophthalmology Associates — St Louis, Missouri, United States
• Ophthalmology Consultantants, Ltd. — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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