RECRUITING Phase 4 ClinicalTrials.gov

Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients

Sponsor: Brett King • ClinicalTrials.gov ID: NCT07847073

Registry updated: 2026-09-29

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Description

The purpose of this study is to compare how two FDA-approved eye drops: netarsudil (Rhopressa) and timolol, protect nerve cells in the eye of adults with open-angle glaucoma. Both medications lower pressure inside the eye, but researchers want to learn if Rhopressa is more effective at slowing down or preventing the loss of retinal ganglion cells. These cells are essential for sight because they carry visual signals from the eye to the brain. Participants in this study will complete a total of 6 study visits over 12 months: * Participants will spend 6 months using Rhopressa eye drops and 6 months using Timolol eye drops. The order of the two eye drops will be chosen randomly. * At scheduled study visits, researchers will examine participants' eyes and measure eye pressure. * Researchers will take detailed pictures of the back of the eye using a specialized high-resolution camera called adaptive optics optical coherence tomography (AO-OCT). * Participants will also complete specialized visual field testing to measure eye function. Researchers will count and track individual nerve cells over time to determine if one medication offers better protection against cell loss than the other.

Interventions

Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA] (Drug)
Netarsudil ophthalmic solution (Rhopressa) is an FDA-approved Rho kinase inhibitor indicated for the treatment of ocular hypertension and open-angle glaucoma. In this study, participants will instill 1 drop of netarsudil 0.02% ophthalmic solution in the study eye once daily in the evening for 6 months.
Timolol Maleate 0.25% Ophthalmic Solution (Drug)
Timolol maleate ophthalmic solution is an FDA-approved non-selective beta-adrenergic receptor blocking agent indicated for the treatment of ocular hypertension and open-angle glaucoma. In this study, participants will instill 1 drop of timolol maleate 0.25% ophthalmic solution in the study eye twice daily (in the morning and evening) for 6 months.

Eligibility criteria

Inclusion Criteria: * All subjects will be 18 years of age or older * Subjects must be diagnosed with open-angle glaucoma and have had an eye exam within the past year * Subjects with glaucoma will have structural (optic nerve and retinal nerve fiber layer) and functional (visual field testing) defects consistent with the diagnosis of glaucoma * Subjects will have a corrected acuity of 20/50 or better and be able to fixate * Naïve to medication subjects or post washout IOP between 18 and 34 mmHg * Spherical equivalent from +3 diopters to -6 diopters, with a cylinder of \<-3 diopters * Subject is willing and able to comply with the protocol requirements and to remain in the study for its full duration, including all scheduled visits and follow-up assessments Exclusion Criteria: * Subjects with a known intolerance to netarsudil ophthalmic solution * Subjects with a known intolerance to, or contraindication for, timolol maleate * Any subject whom the investigator determines to be at unacceptable risk for the washout or believes is unlikely to complete the study * Subjects with retinal disease or optic neuropathies other than glaucoma that, in the opinion of the investigator, could confound the study assessments or outcome * Female subjects who are pregnant, breastfeeding, or of childbearing age who are not sterile or using an acceptable method of contraception during the study

Conditions

Open Angle Glaucoma (OAG) Glaucoma

Locations

Indiana University School Of Optometry — Bloomington, Indiana, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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