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Measuring the Effects of Netarsudil, Latanoprost, and Combination Therapy on Episcleral and Retinal Blood Flow in Ocular Hypertension and Glaucoma Suspects

Measuring the Effects of Netarsudil, Latanoprost, and Combination Therapy on Episcleral and Retinal Blood Flow in Ocular Hypertension and Glaucoma Suspects Using Erythrocyte Mediated Angiography In Vivo

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

Not stated in the study description — ask the study team about visits and procedures.

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 latanoprost with Rocklatan, which combines netarsudil and latanoprost, in adults with high eye pressure or possible glaucoma. It tests whether Rocklatan improves blood flow in veins near the eye’s surface more than latanoprost alone, and whether two imaging methods can reliably measure these changes.

The goal of this clinical trial is to compare participants treated with latanoprost to those treated with Rocklatan (netarsudil/latanoprost) to determine whether the addition of netarsudil results in greater improvements in episcleral venous blood flow in adults with glaucoma or ocular hypertension. Episcleral venous blood flow will be measured using erythrocyte-mediated angiography (EMA) and laser speckle contrast imaging (LSCI). The main questions this study aims to answer are: * Does Rocklatan produce greater increases in episcleral venous blood flow than latanoprost alone? * Can EMA and LSCI reliably detect changes in episcleral venous blood flow following treatment with these medications? Participants will: * Be randomized to receive either latanoprost or Rocklatan * Undergo imaging of the episcleral veins using EMA and LSCI before, during, and after treatment, and * Complete study visits that include standard ophthalmic examinations and intraocular pressure measurements. Hypothesis: The investigators hypothesize that latanoprost, which primarily increases uveoscleral outflow, will not significantly affect the distal episcleral circulation. In contrast, Rocklatan, through its netarsudil component, is expected to produce measurable increases in episcleral venous flow.

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

Eligibility

Who can join

  • You are at least 18 years old.
  • You have high eye pressure or signs of possible glaucoma.
  • You have not used any medicine to lower eye pressure in the past 6 months, including eye drops or medicines taken by mouth.
  • An eye exam shows that your eye’s drainage angles are open.
  • You have at least one recorded visual field test from within 6 months before joining. This test checks how well you see across your field of view.

Who can't join

  • You are in another research study involving drugs or substances that could affect this study’s results or eye vein blood flow. The study doctor decides whether this applies.
  • You have had surgery inside the eye, other than cataract surgery without complications.
  • You have an allergy or past bad reaction to ICG dye, shellfish, or iodine.
  • You have serious liver disease or uremia, a buildup of waste in the blood.
  • You have glaucoma caused by another eye condition, including exfoliation or pigmentary glaucoma, or a history of sudden closure of the eye’s drainage angle.
  • You have moderate or severe loss of your field of vision, based on the study’s grading rules.
  • You have a condition that prevents reliable eye tests, eye pictures, or use of study treatments. Examples include cloudiness inside the eye or a tilted optic nerve head.
  • You are pregnant or breastfeeding.

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

Official eligibility criteria

Inclusion: * Patients are at least 18 years of age. * Patients must have ocular hypertension or be a glaucoma suspect. * Patient must not have used any IOP-lowering medication (topical or systemic) within the past 6 months * Patients must have open angles on gonioscopy. * All patients will have at least one recorded visual field examination within 6 months of enrollment in the study. Visual fields will be assessed using the Hodapp-Andersen-Parish criteria. Exclusion: * Participation in other investigational studies, unless such participation does not involve the administration of any drugs or agents that could impact the results of this study or have an effect on episcleral flow, as determined by the Investigator. * Prior intraocular surgery other than uncomplicated cataract surgery. * Allergy or history of adverse reaction to ICG, shellfish, or Iodine. * Significant liver disease or uremia. * Secondary glaucoma including exfoliation glaucoma, pigmentary glaucoma, or history of acute angle closure. * Moderate or severe visual field deficits as per Hodapp-Anderson-Parish criteria. * Any condition precluding imaging including reliable visual fields, disc photography, or use of study treatments including media opacity or tilted optic disk * Pregnant or nursing patients.

Study sites (4)

MD