13 Participants NeededMy employer runs this trial

Netarsudil vs Timolol for Glaucoma

BJ
KM
Overseen ByKaitlyn M Asher, CCRC, BS
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Brett King
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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 two eye drop medications, netarsudil (Rhopressa) and timolol maleate, to determine which better protects nerve cells in people with open-angle glaucoma. Both medications lower eye pressure, but researchers aim to discover if Rhopressa more effectively prevents the loss of crucial sight-carrying nerve cells. Participants will use each medication for six months and undergo several eye exams and tests to monitor changes. This trial suits individuals diagnosed with open-angle glaucoma, who have had an eye exam in the past year, and can see reasonably well with glasses or contacts. As a Phase 4 trial, this research aims to understand how these FDA-approved treatments benefit a broader range of patients.

What is the safety track record for these treatments?

Research has shown that both netarsudil (Rhopressa) and timolol are generally safe for treating glaucoma, a condition that increases eye pressure.

For netarsudil, studies have found that the most common side effect is redness of the eye, known as conjunctival hyperemia, occurring in about 53% of users. Despite this, netarsudil remains safe and effective in lowering eye pressure, which is crucial for glaucoma patients.

Timolol is also well-tolerated. Some studies reported that about 7% of patients experienced mild eye discomfort. Timolol may slightly lower heart rate in some individuals, but this effect is usually mild. Overall, many people with glaucoma have safely used both medications.

These findings are based on previous research and studies with patients using these eye drops. Both treatments are FDA-approved, indicating they have met safety standards for treating high eye pressure.12345

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for glaucoma, such as Timolol Maleate, which primarily reduce intraocular pressure by decreasing fluid production in the eye, Netarsudil (Rhopressa) offers a unique approach. Netarsudil works by increasing the eye's fluid outflow through a pathway called the trabecular meshwork, which is novel compared to traditional therapies. This distinct mechanism of action could provide an alternative for patients who do not respond adequately to current treatments, offering hope for better pressure control in the eye and potentially improved outcomes. Researchers are excited because Netarsudil's unique pathway might address unmet needs in glaucoma management, offering a new option for patients with this condition.

What evidence suggests that this trial's treatments could be effective for glaucoma?

Research has shown that netarsudil (Rhopressa), which participants in this trial may receive first or second, effectively lowers eye pressure in people with glaucoma. Specifically, studies found that 48% of eyes experienced at least a 20% drop in eye pressure after one month, with this effect lasting for six months. Timolol, another treatment option in this trial, also reduces eye pressure and is commonly used for treating open-angle glaucoma. Most people tolerate it well. Both treatments are approved for lowering eye pressure, which is crucial for protecting the nerve cells in the eye.678910

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with open-angle glaucoma, including pigmentary glaucoma. Participants should be able to attend regular eye exams and follow study instructions. People with other major eye diseases or conditions that could affect the results may not be eligible.

Inclusion Criteria

I have glaucoma with eye test results that confirm the diagnosis.
I am 18 years old or older.
I have open-angle glaucoma and had an eye exam in the last year.
See 4 more

Exclusion Criteria

Subjects with a known intolerance to netarsudil ophthalmic solution
Any subject whom the investigator determines to be at unacceptable risk for the washout or believes is unlikely to complete the study
I do not have serious eye diseases except for glaucoma.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Participants receive either Rhopressa or Timolol for 6 months, depending on randomization

6 months
3 visits (in-person)

Treatment Phase 2

Participants cross over to receive the alternate medication (Rhopressa or Timolol) for another 6 months

6 months
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Netarsudil (Rhopressa)
  • Timolol Maleate

Trial Overview

The study compares two approved eye drops—Rhopressa (netarsudil) and Timolol—to see which better protects nerve cells in the eyes of people with glaucoma. Each participant uses both drops for six months each, in random order, over a year.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Timolol first, then RhopressaExperimental Treatment2 Interventions
Group II: Rhopressa first, then TimololExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brett King

Lead Sponsor

Trials
1
Recruited
1+

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

Effectiveness of Netarsudil as an Additional Therapy for ... - PMC

Of the eyes with baseline IOP ≤ 20 mmHg, 69% achieved treatment success, compared to only 17% of eyes with baseline IOP ≥ 21 mmHg (P < 0.05).

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 ...

208254Orig1s000 - accessdata.fda.gov

The data contained in this submission establishes the efficacy of netarsudil ophthalmic solution, 0.02% dosed once daily in the evening for.

The effectiveness and safety profile of netarsudil 0.02% in ...

One hundred twenty (48%) eyes experienced ≥ 20% decreases in IOP at the 1-month study visit; this effect was maintained through the 6-month ...

Real-world data show additive effects of netarsudil

The addition of netarsudil as an adjunctive treatment yielded further IOP lowering in patients with glaucoma enrolled in a phase 4 study.

208254Orig1s000 - accessdata.fda.gov

The safety database contained in this submission establishes the safety of netarsudil ophthalmic solution, 0.02% dosed once daily in the evening ...

Efficacy and safety of netarsudil 0.02% ophthalmic solution ...

The safety profile of netarsudil differs from other currently approved topical ocular hypotensive agents, and at least half of the patients using it are ...

A Randomized, Phase 2 Study of 24-h Efficacy and ... - PMC

Netarsudil exhibited consistent IOP-lowering efficacy over a 24-h period, with the same reduction from baseline in mean nocturnal IOP (3.5 mmHg) ...

Rhopressa™ (netarsudil ophthalmic solu

The data presented in this briefing document demonstrate that Rhopressa™ (netarsudil ophthalmic solution) 0.02% is safe and effective for the ...

Adaptive Optics OCT Evaluation of Rhopressa's Effects on ...

The purpose of this study is to compare how two FDA-approved eye drops: netarsudil (Rhopressa) and timolol, protect nerve cells in the eye ...