Rhopressa for Glaucoma

Overseen By Rebecca Goldfaden, PharmD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: East Coast Institute for Research

Must not be taking: Rho kinase inhibitors

Disqualifiers: Advanced glaucoma, Retinal disease, others

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

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Rhopressa affects eye pressure in individuals who have undergone SLT in both eyes. Researchers will compare Rhopressa, a medicated eye drop, to artificial tears to determine which more effectively lowers eye pressure. It is suitable for individuals with primary open-angle glaucoma or ocular hypertension who have had SLT within the last 90 days and may need further pressure reduction. As a Phase 4 trial, this research aims to understand how the already FDA-approved treatment benefits more patients.

Will I have to stop taking my current medications?

If you are currently taking IOP-lowering medications, you must be willing to stop them to participate in this trial. There is a required washout period (time without taking certain medications) before starting the study.

What is the safety track record for Rhopressa?

Previous studies have shown that netarsudil ophthalmic solution 0.02%, also known as Rhopressa, is safe for treating eye conditions. Research indicates that it effectively lowers eye pressure and works as well as other treatments like timolol, a common eye medication.

The most common side effect is redness in the eye, known as conjunctival hyperemia, occurring in about 53% of patients. However, this side effect is usually mild and temporary. Other side effects are less common.

Rhopressa has undergone thorough testing in people and consistently lowers eye pressure over time, supporting its safety. The FDA has approved the treatment for use in eye conditions, further confirming its safety.

Overall, the data suggest that Rhopressa is well-tolerated by most patients, with manageable side effects. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Rhopressa (netarsudil ophthalmic solution 0.02%) is unique because it targets a different mechanism in treating glaucoma compared to standard options like prostaglandin analogs or beta-blockers. Most treatments reduce eye pressure by increasing fluid outflow or decreasing fluid production. However, Rhopressa works by inhibiting the Rho kinase enzyme, which improves the outflow of fluid through the eye’s trabecular meshwork, a pathway often underutilized by other treatments. Researchers are excited about Rhopressa because it offers a novel approach that can be used alone or in combination with existing treatments, potentially providing better control of intraocular pressure for patients.

What is the effectiveness track record for Rhopressa in treating glaucoma?

Research has shown that Rhopressa, which contains netarsudil eye drops, lowers eye pressure in people with glaucoma. In this trial, participants will receive either Rhopressa or artificial tears as a placebo comparator. Using Rhopressa once a day can reduce eye pressure by up to 5 mmHg in patients whose initial pressure is below 25 mmHg. This reduction is similar to that achieved by using timolol, another common glaucoma treatment, twice a day. Rhopressa is approved because it effectively manages eye pressure, which is crucial for preventing vision loss in glaucoma patients. Overall, it has a strong record of safety and effectiveness in treating this condition. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with primary open-angle glaucoma or ocular hypertension who've had SLT surgery in the last 90 days. They should have an IOP of 16-28 mmHg and could benefit from further IOP reduction. Women must use birth control if capable of pregnancy. Exclusions include more than one SLT treatment, prior MIGS, current rho kinase inhibitor use, advanced glaucoma, unreliable tonometry readings, active eye infections or inflammation, retinal disease, recent investigational drug/device involvement.

Inclusion Criteria

I have been diagnosed with glaucoma or high eye pressure in both eyes.

I had laser eye surgery in both eyes within the last 3 months.

Mean diurnal intraocular pressure (IOP) of 16 to 28 mmHg at Randomization (V2)

Exclusion Criteria

I have had SLT treatment in my eye more than once.

I have had surgery for glaucoma.

I cannot or do not want to stop my current eye pressure medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Rhopressa or placebo for IOP reduction post-SLT

6 weeks

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 ophthalmic solution 0.02%

Trial Overview The study tests Rhopressa's effect on intraocular pressure (IOP) in patients post-selective laser trabeculoplasty (SLT). Participants will receive Netarsudil ophthalmic solution 0.02% to see if it can further reduce their IOP compared to artificial tears as a control.

How Is the Trial Designed?

Group I: Rhopressa Experimental Treatment 1 Intervention

Group II: Artificial Tears Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

East Coast Institute for Research

Lead Sponsor

Trials

4

Recruited

340+

Alcon, a Novartis Company

Industry Sponsor

Trials

15

Recruited

2,600+

Florida Eye Specialists

Collaborator

Trials

2

Recruited

170+

Published Research Related to This Trial

Netarsudil ophthalmic solution 0.02% effectively lowers intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, showing significant reductions in IOP comparable to the standard treatment of twice-daily timolol over three months in phase III trials.

The most common side effect was mild conjunctival hyperemia, which did not worsen with continued use, and netarsudil had minimal serious or systemic adverse effects, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Netarsudil ophthalmic solution 0.02% for the treatment of patients with open-angle glaucoma or ocular hypertension. Kopczynski, CC., Heah, T.[2019]

Rhopressa (netarsudil) is an effective treatment for open-angle glaucoma that works by inhibiting norepinephrine transport and Rho-associated protein kinase (ROCK), but it can cause side effects like conjunctival hyperemia.

This case report highlights a unique instance of Rhopressa-induced corneal edema in a 79-year-old woman without prior corneal issues, suggesting that there may be unknown effects of the treatment that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rhopressa-induced corneal edema: a case report. Chu, MJ., Song, M., Palmares, T., et al.[2021]

Netarsudil ophthalmic solution 0.02% is a newly approved treatment for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension, working by enhancing aqueous humour outflow through the trabecular meshwork.

The recommended dosage is one drop in the affected eye(s) once daily in the evening, and further clinical development is ongoing in Europe and Japan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Netarsudil Ophthalmic Solution 0.02%: First Global Approval. Hoy, SM.[2019]

In a study of 133 glaucoma patients prescribed netarsudil, the medication led to a modest average reduction in intra-ocular pressure (IOP) of -0.8 mmHg, with 67% of eyes showing a decrease, indicating variable efficacy in this population.

However, netarsudil had a high discontinuation rate of 52%, primarily due to reasons such as the need for surgery, allergies, and cost, highlighting challenges in patient compliance and the need for careful consideration of treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pragmatic adjunctive usage of netarsudil: A retrospective chart review from a tertiary care center. Goergen, NS., Gagrani, M., Gulati, V., et al.[2022]

In a study of 340 eyes from 233 glaucoma patients, netarsudil 0.02% significantly reduced intraocular pressure (IOP) by at least 20% in 48% of eyes after one month, with effects maintained over six months, even in patients already using multiple glaucoma medications.

While netarsudil was generally safe, 27.6% of patients reported conjunctival hyperemia and 31.1% experienced blurred vision, though these did not lead to significant visual acuity loss; 15.6% discontinued due to insufficient IOP-lowering effects or side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness and safety profile of netarsudil 0.02% in glaucoma treatment: real-world 6-month outcomes. Shiuey, EJ., Mehran, NA., Ustaoglu, M., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7647436/

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%, ...

2. rhopressa.myalcon.com rhopressa.myalcon.com/ecp/efficacy/

Efficacy | RHOPRESSA® for ECPs RHOPRESSA® provided IOP reduction up to 5 mmHg in patients with baselines <25 mmHg ... RHOPRESSA® was evaluated in 3 randomized, controlled clinical trials in ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06865144

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.

4. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2017/208254Orig1s000SumR.pdf

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.

5. ophthalmologyglaucoma.org ophthalmologyglaucoma.org/article/S2589-4196(22)00098-9/abstract

Netarsudil as a Predictor of Response for MicroPulse ... From netarsudil, 44.4% of eyes were successful; from MPTLT, 55.3% of eyes were successful. The mean IOP reductions were 2.83 ± 5.74 mmHg from ...

6. fda.gov fda.gov/media/108389/download

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 ...

7. rhopressa.myalcon.com rhopressa.myalcon.com/ecp/safety-and-dosing/

Safety and Dosing | RHOPRESSA® for ECPs The most common ocular adverse reaction observed in controlled clinical studies with Rhopressa® dosed once daily was conjunctival hyperemia, reported in 53% of ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06394973

NCT06394973 | Efficacy and Safety Assessment of T4090 ... Efficacy and Safety Assessment of T4090 Ophthalmic Solution Versus Rhopressa® Ophthalmic Solution in Patients with Open-angle Glaucoma or Ocular Hypertension.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7755039/

Safety and efficacy of topically administered netarsudil ... Netarsudil 0.02% (Rhopressa™) was developed and optimized for human application. Studies in humans showed stable, long-term IOP reductions between 3.9–6.9 mmHg ...