Netarsudil for Glaucoma and Ocular Hypertension

Overseen By Brett J King, OD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Indiana University

Disqualifiers: Corneal disease, Intolerance to netarsudil, others

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

Compensation: Varies

Number of Visits: 3

Duration: 2-3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This study evaluates the effects of netarsudil (Rhopressa) on the trabecular meshwork in subjects with ocular hypertension or open-angle glaucoma. Participants will be randomized to receive either netarsudil or placebo (artificial tears). High-resolution imaging using adaptive optics gonioscopy, anterior segment optical coherence tomography (AS-OCT), and OCT gonioscopy will be performed at baseline and after approximately 14 days of treatment. The primary objective is to assess changes in trabecular meshwork lamellae spacing, with secondary measures including trabecular meshwork height, width, and Schlemm's canal diameter.

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)

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

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?

Group I: Netarsudil (Rhopressa) Active Control 1 Intervention

Participants will receive netarsudil ophthalmic solution administered as one drop in the study eye once daily in the evening for approximately 14 days.

Group II: Placebo (Artificial Tears) Placebo Group 1 Intervention

Participants will receive artificial tears administered as one drop in the study eye once daily in the evening for approximately 14 days.

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

Alcon Research

Chief Medical Officer since 2022

MD from Harvard Medical School

David Endicott

Alcon Research

Chief Executive Officer since 2018

MBA from University of Southern California