Ripasudil Eye Drops for Cataract Surgery

Recruiting at 47 trial locations

Overseen By Director, Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Kowa Research Institute, Inc.

Disqualifiers: Pregnancy, Recent eye surgery, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

331 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

How is Ripasudil eye drops unique for cataract surgery?

Ripasudil eye drops are unique because they are being explored specifically for use in cataract surgery, which is different from other treatments that focus on post-operative discomfort or dry eye relief. This suggests a novel application of Ripasudil, potentially offering benefits during the surgical process itself, unlike other eye drops that are typically used after surgery. ^{1 2 3 4 5}

Research Team

Shona Pendse, MD, MMSc

Principal Investigator

Kowa Pharma Development Co.

Eligibility Criteria

Inclusion Criteria

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.

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.

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).

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive K-321 or placebo ophthalmic solution four times daily for 12 weeks

12 weeks

Regular visits for treatment administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-14 weeks

Follow-up visits to assess safety and efficacy

Extension

Participants in some groups undergo an extended follow-up period

14 weeks

Treatment Details

Interventions

• Placebo
• Ripasudil

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.

Who Is Running the Clinical Trial?

Kowa Research Institute, Inc.

Lead Sponsor

Trials

46

Recruited

16,400+

References

1. United States pubmed.ncbi.nlm.nih.gov

Evaluation of eyedrop administration by inexperienced patients after cataract surgery. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Multicenter randomized phase 3 study of a sustained-release intracanalicular dexamethasone insert for treatment of ocular inflammation and pain after cataract surgery. [2020]

3. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The effects of a trehalose-based drug used after laser keratorefractive surgeries]. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Trehalose/sodium hyaluronate eye drops in post-cataract ocular surface disorders. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Clinical evaluation of an HP-guar gellable lubricant eye drop for the relief of dryness of the eye. [2022]