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
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Total Duration
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Brief Title
Who Can Participate
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Sponsors
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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
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
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
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
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.
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