Ripasudil Eye Drops for Cataract Surgery

No longer recruiting at 51 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests eye drops called Ripasudil to determine their safety and effectiveness after cataract surgery. As a Phase 3 trial, it represents one of the final steps before the treatment can gain approval for regular use. Participants will receive either Ripasudil or a placebo (a substance with no active drug) for 12 weeks to compare results. Ideal candidates are those planning to undergo cataract surgery and who have not had recent eye surgery. This Phase 3 trial offers participants the opportunity to contribute to a potentially groundbreaking treatment before FDA approval.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Ripasudil eye drops are likely safe for people after cataract surgery. One study found that Ripasudil helped protect eye cells often lost after this type of surgery, indicating that the treatment is effective and easy for patients to handle. Additionally, tests on people with glaucoma showed that Ripasudil was generally safe. These studies provide strong evidence that Ripasudil eye drops are safe for humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for cataracts, which often involve surgical procedures, Ripasudil eye drops offer a non-invasive alternative. Ripasudil works by targeting and modulating the Rho-associated protein kinase (ROCK) pathway, which is different from most cataract treatments that focus on physical lens removal. Researchers are excited about Ripasudil because it has the potential to address the underlying biochemical processes in the eye, possibly delaying the need for surgery. This unique mechanism of action could provide a new avenue for cataract management, making treatment more accessible and less intimidating for patients.

What evidence suggests that Ripasudil might be an effective treatment for cataract surgery?

Research shows that Ripasudil eye drops, which participants in this trial may receive, can protect eyes after cataract surgery. Studies have found that Ripasudil significantly reduces the loss of important cells that keep the front part of the eye clear. This means using Ripasudil can improve vision after surgery. The treatment also helps with eye swelling, enhancing vision and comfort. These findings suggest that Ripasudil could be a good option for people recovering from cataract surgery. ^{1 2 3 6 7}

Who Is on the Research Team?

Shona Pendse, MD, MMSc

Principal Investigator

Kowa Pharma Development Co.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Ripasudil

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05528172?term=AREA%5BBasicSearch%5D(AREA%5BInterventionSearch%5D(K-321))&rank=4

A Study to Investigate the Safety and Efficacy of Ripasudil ... A Study to Investigate the Safety and Efficacy of Ripasudil ( K-321 ) Eye Drops After Cataract Surgery. ClinicalTrials.gov ID NCT05528172. Sponsor Kowa ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11109060/

The Protective Effect of Rho-Associated Kinase Inhibitor Eye ... Ripasudil, a medication, shows promise in significantly reducing endothelial cell loss after cataract surgery, with a regimen of one drop ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05528172

A Study to Investigate the Safety and Efficacy of Ripasudil ... A Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Cataract Surgery. ClinicalTrials.gov ID NCT05528172. Sponsor Kowa ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12347265/

Clinical Evaluation of Ripasudil for Corneal Edema Patients with edema post-cataract surgery received treatment for 5.03 ± 2.66 months. Those with FECD were treated for 4.97 ± 1.95 months. For ...

5. journals.lww.com journals.lww.com/tjop/fulltext/2024/14010/evaluating_the_efficacy_of_rho_kinase_inhibitor.12.aspx

Evaluating the efficacy of Rho kinase inhibitor eye drops... The results suggest that ripasudil treatment significantly impacts BCVA and CCT, with a marginal increase in ECC. Corneal edema management has evolved over the ...

6. cochranelibrary.com cochranelibrary.com/content?templateType=related&urlTitle=/central/doi/10.1002/central/CN-02169390&doi=10.1002/central/CN-02169390&p_p_id=scolariscontentdisplay_WAR_scolariscontentdisplay&_scolariscontentdisplay_WAR_scolariscontentdisplay_action=related-content&p_p_lifecycle=0&p_p_mode=view&type=central&contentLanguage=

A Study to Investigate the Safety and Efficacy of Ripasudil ... A Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Descemetorhexis in Patients with Fuchs Endothelial Corneal Dystrophy.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2451865423001060

A multicenter phase II study on the safety of rho-kinase ... This study is a multicenter, open-label, single-arm, phase II trial to evaluate the safety and efficacy of ripasudil in glaucoma patients after the needling ...