Effect of Netarsudil vs Brimonidine in NTG Patients on Latanoprost

Effect of the Addition of Netarsudil 0.02% vs. Brimonidine 0.1% in Normal Tension Glaucoma Patients Currently on Latanoprost 0.005%

A randomized, multicenter, investigator-masked prospective study of NTG patients currently on latanoprost 0.005% monotherapy, to study the effect of IOP change with the introduction of netarsudil 0.02% vs brimonidine 0.1%. Subjects will be assessed at a screening visit, and 1 follow-up visit. Clinical evaluations will include visual acuity and IOP .

Study Overview

• Status: Completed
• Conditions: Normal Tension Glaucoma
• Intervention / Treatment: Drug: Netarsudil; Drug: Brimonidine

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78746
      • Westlake Eye Specialists - Austin Office
    • Killeen, Texas, United States, 76549
      • Westlake Eye Specialists - Killeen Office
    • Kyle, Texas, United States, 78640
      • Westlake Eye Specialists - Kyle Office
    • New Braunfels, Texas, United States, 78130
      • Westlake Eye Specialists - New Braunfels Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients 18 years and older

• Diagnosed with normal tension glaucoma based on the following:

  • IOP ≤ 21mmHg
  • Optic nerve rim thinning and/or retinal nerve fiber layer (RNFL) loss consistent with glaucoma
  • Normal visual field OR visual field loss consistent with optic nerve or RNFL defects within the last year
  • Open angles assessed by gonioscopy
• Have been on latanoprost monotherapy for at least 6 weeks

Exclusion Criteria:

If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

• Patients with angle closure glaucoma or secondary forms of glaucoma due to neovascularization of the angle, uveitic glaucoma, congenital glaucoma, or glaucoma due to congenital anomalies.
• Other forms of secondary glaucoma.
• Patients with abnormal anterior segment examination other than cataract will be excluded from the study.
• Patients who have had incisional surgery for glaucoma (eg: MIGs).
• Patients with refractory CME or CME persisting 3 months or more.
• Children, cognitive impaired and critically ill subjects will not be enrolled.
• Central Corneal Thickness (CCT) ≤ 500.
• Prior allergy to brimonidine or netarsudil, and known to have previously failed either brimonidine or netarsudil.
• Ocular surgery (e.g., cataract, laser, refractive) during the study or 1 year prior to entering the study.

The principal investigator reserves the right to declare a patient ineligible or non- evaluable based on medical evidence that indicates they are unsuitable for the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Netarsudil; netarsudil 0.02%	Drug: Netarsudil; netarsudil 0.02%
Active Comparator: Brimonidine; brimonidine 0.1%	Drug: Brimonidine; brimonidine 0.1%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean diurnal intraocular pressure	Intraocular pressure will be measure at 8am, 12pm, and 4pm	After 6 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean intraocular pressure at 8am		After 6 weeks of treatment
Mean intraocular pressure at 12pm		After 6 weeks of treatment
Mean intraocular pressure at 4pm		After 6 weeks of treatment
Percentage of diurnal intraocular pressure reduction	Intraocular pressure will be measure at 8am, 12pm, and 4pm	After 6 weeks of treatment

Collaborators and Investigators

• Sponsor: Westlake Eye Specialists
• Collaborators: Sengi
• Investigators: Principal Investigator: Zarmeena Vendal, MD, Westlake Eye Specialists

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2024
• Primary Completion (Actual): September 22, 2025
• Study Completion (Actual): September 22, 2025

Study Registration Dates

• First Submitted: June 3, 2024
• First Submitted That Met QC Criteria: June 3, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Estimated): October 22, 2025
• Last Update Submitted That Met QC Criteria: October 21, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Optic Nerve Diseases; Ocular Hypertension; Glaucoma; Low Tension Glaucoma; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quinoxalines; Brimonidine Tartrate; netarsudil
• Other Study ID Numbers: ZV-24-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes