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RecruitingPhase 4

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 6 visits
  • Time periods mentioned: 12 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two approved eye drops, Rhopressa and timolol, in adults with open-angle glaucoma. Researchers want to learn if Rhopressa better protects the eye’s nerve cells, which send sight signals to the brain. Participants use each drop for 6 months and have 6 study visits over 12 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 or older.
  • Have open-angle glaucoma and have had an eye exam in the past year.
  • Have damage to the eye’s nerve and nerve fiber layer, plus vision test results that match glaucoma.
  • Have vision of 20/50 or better with glasses or contacts, and be able to keep looking at one spot.
  • Have eye pressure between 18 and 34 mmHg before starting medicine or after a break from eye pressure medicine.
  • Have a glasses prescription within the study’s limits: +3 to -6 diopters overall, with a cylinder value below -3 diopters. These numbers measure lens strength and correction for uneven eye shape.
  • Be willing and able to follow study rules and attend all visits and follow-up tests.

Who can't join

  • Have a known problem tolerating netarsudil (Rhopressa) eye drops.
  • Have a known problem tolerating timolol, or a medical reason you cannot safely use it.
  • The study doctor thinks a break from eye pressure medicine would be too risky, or that you are unlikely to finish the study.
  • Have another disease of the retina (the light-sensing layer at the back of the eye) or eye nerve that could affect the study results.
  • Be pregnant or breastfeeding, or be able to become pregnant without using an acceptable birth control method during the study.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

IN