Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID06865144

Prospective, Randomized, Double-Masked Study to Evaluate the Effect of Rhopressa Versus Placebo on Intraocular Pressure in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension After Selective Laser Trabeculoplasty

Led by East Coast Institute for Research · Updated on 2025-07-02

70

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

E

East Coast Institute for Research

Lead Sponsor

A

Alcon, a Novartis Company

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating how Rhopressa (netarsudil) ophthalmic solution affects intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG) or ocular hypertension who have undergone selective laser trabeculoplasty (SLT) in both eyes. This study aims to understand if starting Rhopressa after 360 degrees SLT can lower IOP more than SLT alone. The trial is a prospective, randomized, double-masked, placebo-controlled study conducted at a single center with 70 participants. Participants will be randomly assigned to receive either Rhopressa 0.02% ophthalmic solution or artificial tears as a placebo. Both treatments involve applying one drop in each eye every evening. The study duration for each participant is expected to be 6 weeks, with up to 12 weeks allowed if a medication washout period is needed before starting the trial. There are three scheduled visits during the study. During the study, participants will have their IOP measured, focusing on the mean diurnal IOP at 42 days as the primary outcome. Other assessments include monitoring adherence to the eye drop regimen and safety evaluations. This information will help healthcare providers decide on the best treatment approach for patients who have recently undergone 360 degrees SLT and may need additional IOP reduction.

CONDITIONS

Brief Title

Effect of Rhopressa on Intraocular Pressure (IOP) in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension Post-SLT

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosed with bilateral primary open-angle glaucoma or ocular hypertension
  • Completed selective laser trabeculoplasty (SLT) in both eyes within the last 90 days
  • Mean diurnal intraocular pressure between 16 and 28 mmHg at randomization
  • Considered by investigator to benefit from additional intraocular pressure reduction and be a candidate for Rhopressa
  • Completed required washout period if previously treated with intraocular pressure-lowering medications
  • If female, either unable to become pregnant, post-menopausal for at least 2 years, or willing to use effective birth control during the study
Not Eligible

You will not qualify if you...

  • History of more than one SLT treatment in either eye
  • Unable or unwilling to stop current intraocular pressure-lowering medications if needed
  • Prior or current treatment with a rho kinase inhibitor
  • Prior microinvasive glaucoma surgery
  • Advanced stage of glaucoma as determined by investigator
  • Conditions preventing reliable intraocular pressure measurement (e.g., corneal abnormalities)
  • Previous or active corneal disease affecting study outcomes
  • Active or recurrent intraocular infection, inflammation, iritis, or uveitis
  • Retinal diseases such as diabetic retinopathy or macular degeneration
  • Intraocular injection within 6 months prior to screening
  • Expected use of topical ocular steroids or nonsteroidal anti-inflammatory drugs during study
  • Current participation in other drug or device trials or recent investigational drug/device use
  • Any condition that may confound study results as judged by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 to 12 weeks

Participants receive Rhopressa or placebo eye drops every evening following selective laser trabeculoplasty (SLT) to evaluate the effect on intraocular pressure.

3 scheduled study visits

Trial Site Locations

Total: 1 location

1

East Coast Institute for Research at Florida Eye Specialists

Jacksonville, Florida, United States, 32256

Actively Recruiting

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Research Team

R

Rebecca Goldfaden, PharmD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

A multicenter, open-label study of netarsudil for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension in a real-world setting.

Fiaz Zaman, Stephen C Gieser, Gail F Schwartz...

https://pubmed.ncbi.nlm.nih.gov/33733980

Selective laser trabeculoplasty versus eye drops for first-line treatment of ocular hypertension and glaucoma (LiGHT): a multicentre randomised controlled trial.

Gus Gazzard, Evgenia Konstantakopoulou, David Garway-Heath...

https://pubmed.ncbi.nlm.nih.gov/30862377

The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma.

Michael A Kass, Dale K Heuer, Eve J Higginbotham...

https://pubmed.ncbi.nlm.nih.gov/12049574