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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

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Phase: Not specified to Phase 4v4 Show 11 more changesShow less
    • Enrollment target: 10 to 50
    • Primary and study completion dates: Feb 22, 2022 to Mar 17, 2027
    • Start date: Mar 15, 2021 to Jul 2, 2026
    • Primary endpoints revised (2)
    • Trial status: Completed to Recruiting
    • Interventions: Netarsudil ophthalmic solution 0.02% one drop nightly for 1-2 weeks (Drug) to Latanoprost (0.005%) (Drug), Rocklatan (Netarsudil 0.02%/ latanoprost 0.005) (Drug)
    • Eligibility criteria revised
    • Study description expanded, about 120 words
    • Site details revised at 4 of 4 sites
    • Collaborator revised
    • Study title expanded, about 4 words
  2. Trial status: Recruiting to Completed
    • Primary and study completion dates changed from estimate of Mar 15, 2022 to Feb 22, 2022
    • Site details revised at 4 of 4 sites
    v3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary and study completion dates: Jun 2021 to Mar 15, 2022
    • Start date changed from estimate of Jun 2020 to Mar 15, 2021
    • Study sites: 5 to 4
    • Study description expanded, about 4 words
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04401982
Lead Sponsor University of Maryland, Baltimore
Collaborators: Alcon Research
Conditions
(from sponsor)		 Ocular Hypertension, Suspect Glaucoma
Related terms Ocular Hypertension
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov