50 Participants NeededMy employer runs this trial

Netarsudil for Glaucoma and Ocular Hypertension

BJ
Overseen ByBrett J King, OD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Indiana University
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of netarsudil (Rhopressa) for individuals with ocular hypertension (high eye pressure) or open-angle glaucoma. Researchers aim to determine if this treatment affects the trabecular meshwork, which helps drain fluid and maintain eye pressure. Participants will receive either netarsudil (an ophthalmic solution) or a placebo (artificial tears) for about two weeks. The trial is suitable for those diagnosed with ocular hypertension or open-angle glaucoma, who have had an eye exam in the past year, and do not have certain eye conditions that could interfere with the study. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop your current medications. However, it mentions a 'washout' period, which means you might need to stop certain eye medications before starting the trial. It's best to discuss this with the trial team.

What is the safety track record for netarsudil (Rhopressa)?

Research has shown that netarsudil, also known as Rhopressa, is generally safe for use. Studies have demonstrated its effectiveness in lowering eye pressure in patients with glaucoma and high eye pressure. Importantly, the FDA has already approved netarsudil for these conditions, indicating a strong safety record.

A long-term study found that using netarsudil once a day was well-tolerated over 12 months. Common side effects include redness at the application site, eye discomfort, and blurred vision, but these are usually mild. Overall, patients using netarsudil have not reported serious side effects in large numbers, supporting its safe use for many people.12345

Why are researchers enthusiastic about this study treatment?

Netarsudil (Rhopressa) is unique because it targets the trabecular meshwork, a key drainage pathway in the eye, to reduce intraocular pressure in glaucoma and ocular hypertension patients. Unlike most treatments that mainly increase fluid outflow through other pathways or decrease fluid production, Netarsudil works by inhibiting Rho kinase. This mechanism not only enhances fluid drainage but also potentially offers neuroprotective benefits, which could be a game-changer in preventing vision loss. Researchers are excited because this dual-action approach addresses both pressure reduction and nerve protection, offering a comprehensive treatment option.

What is the effectiveness track record for netarsudil in treating glaucoma and ocular hypertension?

Research has shown that netarsudil (Rhopressa), which participants in this trial may receive, effectively lowers eye pressure in individuals with open-angle glaucoma or high eye pressure. Studies have found it can reduce eye pressure by 1-5 mmHg, which is important for managing these conditions. One study demonstrated that netarsudil performed as well as timolol, a common glaucoma treatment taken twice daily. For patients with lower starting eye pressure, 69% achieved treatment success, indicating a significant reduction. Overall, netarsudil effectively lowers eye pressure, crucial for preventing optic nerve damage and protecting vision.12356

Are You a Good Fit for This Trial?

This trial is for adults 18 or older who have been diagnosed with ocular hypertension or open-angle glaucoma. Participants must have had an eye exam in the past year, good enough vision (20/100 or better), and certain eye pressure and structure findings.

Inclusion Criteria

Eye examination within the past year
Open anterior chamber angle as confirmed by gonioscopy and anterior segment optical coherence tomography (AS-OCT)
Intraocular pressure between 18 and 34 mmHg (treatment-naïve or after washout, if applicable)
See 4 more

Exclusion Criteria

Any condition that, in the opinion of the investigator, would place the subject at increased risk or interfere with study completion
Known intolerance to netarsudil ophthalmic solution
Inability to tolerate gonioscopy procedures
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Washout

Participants may undergo a washout period if currently treated with glaucoma medications

2 weeks

Treatment

Participants receive either netarsudil or placebo for approximately 14 days

2-3 weeks
2 visits (in-person)

Follow-up

Participants are monitored for changes in trabecular meshwork and other anatomical parameters

2-3 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Artificial Tears
  • Netarsudil Ophthalmic Solution (Rhopressa)

Trial Overview

The study compares netarsudil (Rhopressa) eye drops to artificial tears (placebo) in people with high eye pressure or glaucoma. Eye imaging will be done before and after about two weeks of treatment to see how the medication affects parts of the eye that control fluid drainage.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: Netarsudil (Rhopressa)Active Control1 Intervention
Group II: Placebo (Artificial Tears)Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials
1,063
Recruited
1,182,000+

Alcon Research

Industry Sponsor

Trials
739
Recruited
128,000+
Raquel C. Bono profile image

Raquel C. Bono

Alcon Research

Chief Medical Officer since 2022

MD from Harvard Medical School

David Endicott profile image

David Endicott

Alcon Research

Chief Executive Officer since 2018

MBA from University of Southern California

Citations

Pooled Efficacy and Safety Profile of Netarsudil Ophthalmic ...

In pooled phase III analyses, once-daily netarsudil 0.02% resulted in intraocular pressure (IOP) reduction that was noninferior to twice-daily timolol 0.5%, ...

Effect of Rhopressa on Intraocular Pressure (IOP) in ...

The purpose of this study is to collect data about how Rhopressa affects IOP in patients who have had an SLT procedure in both eyes. Detailed Description.

Efficacy | RHOPRESSA® for ECPs

For patients with baseline IOP ≥25 mmHg, RHOPRESSA® resulted in smaller mean IOP reductions at the morning time points on Days 43 and 90; the difference in mean ...

Effectiveness and Tolerability of Netarsudil in Combination ...

A sustained ≥ 20% IOP reduction was observed in 16.2% of 123 eyes with at least 2 observations on treatment with netarsudil. Of the 138 subjects who were ...

Rhopressa™ (netarsudil ophthalmic solu

Also in this study of subjects with low baseline IOP (14 to 20 mmHg), netarsudil produced substantial IOP reductions that were statistically ...

Long-term Safety and Ocular Hypotensive Efficacy ...

In this randomized, double-masked trial, once-daily dosing of netarsudil 0.02% was effective, consistently lowering IOP through 12 months, and was tolerated by ...