Recruiting

Latanoprost vs. Rocklatan

Sponsor:

University of Maryland, Baltimore

Code:

NCT04401982

Conditions

Ocular Hypertension

Suspect Glaucoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rocklatan (Netarsudil 0.02%/ latanoprost 0.005)

Latanoprost (0.005%)

Study Details

Brief summary:

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.

Conditions

Ocular Hypertension

Suspect Glaucoma

Study ID

NCT04401982

Start date

Jul 2, 2026

Status verified date

Jun, 2026

Completion date

Mar 17, 2027

Anticipated

Primary completion date

Mar 17, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Glaucoma Suspect

Individuals with a diagnosis of glaucoma suspect

Interventions

Rocklatan (Netarsudil 0.02%/ latanoprost 0.005)

Rocklatan (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%)

Latanoprost 0.005% one drop nightly for 28-35 days, then 14-28 days if randomized to continue on latanoprost.

Primary outcome measure

  • Change in Episcleral Venous Blood Flow Measured by Erythrocyte-Mediated Angiography (EMA) [ Time Frame: Baseline (T0), 28-35 days from baseline (T1), 14-28 days from T1 (T2) ]
  • Change in Retinal Arteriolar and Venular Blood Flow Measured by Erythrocyte-Mediated Angiography (EMA) [ Time Frame: Baseline (T0), 28-35 days from baseline (T1), 14-28 days from T1 (T2) ]

Central Contacts and Locations

Central contacts

Osamah Saeedi, MD

(410) 328-5929osaeedi@som.umaryland.edu

Zaina L Maharoof, BS

(667) 214-1463eyeresearch@som.umaryland.edu

Locations

University of Maryland Medical Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Osamah Saeedi

osaeedi@som.umaryland.edu

University Physicians Inc.

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Alfred L Vinnett, BS

(667) 214-1232eyeresearch@som.umaryland.edu

UM Faculty Physicians, Inc. | 5900 Waterloo Crossing

Recruiting

Columbia, Maryland, United States, 21045

Contacts

Osamah Saeedi, MD

410-328-3865

Principal Investigator:

Osamah Saeedi, MD

Maryland Eye Consultants and Surgeons

Recruiting

Silver Spring, Maryland, United States, 20902

Principal Investigator:

Osamah Saeedi, MD

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Jul 2, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-12. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-07-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.