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

Kowa

Status and phase: Completed; Phase 3

Conditions: Corneal Edema After Cataract Surgery

Treatments: Drug: Placebo; Drug: Ripasudil

Study type: Interventional

Funder types: Industry

Identifiers

NCT05528172

K-321-302

Details and patient eligibility

About

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

Enrollment: 331 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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331 participants in 4 patient groups, including a placebo group

Group A

Experimental group

Description:

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

Treatment:

Drug: Ripasudil

Group B

Experimental group

Description:

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

Treatment:

Drug: Ripasudil

Group C

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Group D

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo