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

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kowa Research Institute, Inc.

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.

• 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.

Exclusion Criteria:

• Is a female subject of childbearing potential and any of the following is true:

1. is pregnant or lactating/breastfeeding, or

2. 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).

3. 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