Effect of Netarsudil vs Brimonidine in NTG Patients on Latanoprost

Last updated: June 25, 2024
Sponsor: Westlake Eye Specialists
Overall Status: Active - Recruiting

Phase

4

Condition

Glaucoma

Treatment

Brimonidine

Netarsudil

Clinical Study ID

NCT06449352
ZV-24-01
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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 .

Eligibility Criteria

Inclusion

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) lossconsistent with glaucoma

  • Normal visual field OR visual field loss consistent with optic nerve or RNFLdefects within the last year

  • Open angles assessed by gonioscopy

  • Have been on latanoprost monotherapy for at least 6 weeks

Exclusion

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 toneovascularization of the angle, uveitic glaucoma, congenital glaucoma, or glaucomadue to congenital anomalies.

  • Other forms of secondary glaucoma.

  • Patients with abnormal anterior segment examination other than cataract will beexcluded 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 failedeither brimonidine or netarsudil.

  • Ocular surgery (e.g., cataract, laser, refractive) during the study or 1 year priorto 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 Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Brimonidine
Phase: 4
Study Start date:
June 13, 2024
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Westlake Eye Specialists - Austin Office

    Austin, Texas 78746
    United States

    Active - Recruiting

  • Westlake Eye Specialists - Killeen Office

    Killeen, Texas 76549
    United States

    Active - Recruiting

  • Westlake Eye Specialists - Kyle Office

    Kyle, Texas 78640
    United States

    Active - Recruiting

  • Westlake Eye Specialists - New Braunfels Office

    New Braunfels, Texas 78130
    United States

    Active - Recruiting

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