About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Single group
Treatments tested in this trial
Rocklatan (Netarsudil 0.02%/ latanoprost 0.005)
DrugRocklatan (Netarsudil 0.02%/ latanoprost 0.005) one drop nightly for 14-28 days, if randomized to Rocklatan after 28-35 days on Latanoprost.
Latanoprost (0.005%)
DrugLatanoprost 0.005% one drop nightly for 28-35 days, then 14-28 days if randomized to continue on latanoprost.
Treatment groups
Trial outcomes
Primary outcomes
Change in Episcleral Venous Blood Flow Measured by Erythrocyte-Mediated Angiography (EMA)
Change in episcleral venous blood flow following treatment with latanoprost 0.005% and/or Rocklatan, as measured by erythrocyte-mediated angiography (EMA). EMA will be used to quantify episcleral blood flow through measurement of erythrocyte velocity and vessel diameter, allowing calculation of absolute blood flow at baseline (T0), after 28-35 days of latanoprost treatment (T1), and after an additional 14-28 days of either continued latanoprost or switching to Rocklatan (T2).
Change in Retinal Arteriolar and Venular Blood Flow Measured by Erythrocyte-Mediated Angiography (EMA)
Change in retinal blood flow within arterioles and venules less than 100 microns in diameter following treatment with latanoprost 0.005% and/or Rocklatan, as measured by erythrocyte-mediated angiography (EMA). EMA will be used to quantify retinal blood flow through measurement of erythrocyte velocity and vessel diameter at baseline (T0), after 28-35 days of latanoprost treatment (T1), and after an additional 14-28 days of either continued latanoprost or switching to Rocklatan (T2).
Sponsors and contacts
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University of Maryland, Baltimore
Lead sponsor
Alcon Research
Collaborator