Effect of Netarsudil vs Brimonidine in NTG Patients on Latanoprost

Phase 4

Recruiting

• Conditions: Normal Tension Glaucoma
• Interventions: Drug: Brimonidine; Drug: Netarsudil

• Registration Number: NCT06449352
• Lead Sponsor: Westlake Eye Specialists

Brief 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 .

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-03
• Study First Submitted QC: 2024-06-03
• Study First Posted: 2024-06-10
• Study Start: 2024-06-13
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-26
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brimonidine	Brimonidine	brimonidine 0.1%
Netarsudil	Netarsudil	netarsudil 0.02%

Primary Outcome Measures

Name	Time	Method
Mean diurnal intraocular pressure	After 6 weeks of treatment	Intraocular pressure will be measure at 8am, 12pm, and 4pm

Secondary Outcome Measures

Name	Time	Method
Percentage of diurnal intraocular pressure reduction	After 6 weeks of treatment	Intraocular pressure will be measure at 8am, 12pm, and 4pm
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

Trial Locations

Locations (4)

Westlake Eye Specialists - New Braunfels Office; 🇺🇸 New Braunfels, Texas, United States

Westlake Eye Specialists - Kyle Office; 🇺🇸 Kyle, Texas, United States

Westlake Eye Specialists - Austin Office; 🇺🇸 Austin, Texas, United States

Westlake Eye Specialists - Killeen Office; 🇺🇸 Killeen, Texas, United States