Ripasudil Eye Drops for Cataract Surgery

Recruiting in Palo Alto (17 mi)

+47 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Kowa Research Institute, Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests K-321 to see if it helps people recover better after cataract surgery. It focuses on ensuring the treatment is safe and effective for these patients.

Eligibility Criteria

Inclusion Criteria

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.

Meet all other inclusion criteria outlined in clinical study protocol.

Exclusion Criteria

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).

Treatment Details

Interventions

• Placebo (Procedure)
• Ripasudil (Rho kinase inhibitor)

Participant Groups

Group I: Group B Experimental Treatment 1 Intervention

Participants receive K-321 ophthalmic solution Four times daily(QID) for 12 Weeks followed by a 14 week follow-up period with no treatment.

Group II: Group A Experimental Treatment 1 Intervention

Participants receive K-321 ophthalmic solution Four times daily(QID) for 12 Weeks followed by a 4 week follow-up period with no treatment.

Group III: Group C Placebo Group 1 Intervention

Participants will receive K-321 Placebo ophthalmic solution QID for 12 Weeks followed by a 4 week follow-up period with no treatment.

Group IV: Group D Placebo Group 1 Intervention

Participants will receive K-321 Placebo ophthalmic solution QID for 12 Weeks followed by a 14 week follow-up period with no treatment.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Eye Care Institute/Butchertown Clinical Trials Louisville, KY

Silverstein Eye Centers Kansas City, MO

Ophthalmology Consultantants, Ltd. Saint Louis, MO

Comprehensive Eye Care, Ltd. Washington, MO

More Trial Locations

Who Is Running the Clinical Trial?

Kowa Research Institute, Inc. Lead Sponsor

References