Effect of Netarsudil vs Brimonidine in NTG Patients on Latanoprost

Westlake Eye Specialists

Status and phase: Completed; Phase 4

Conditions: Normal Tension Glaucoma

Treatments: Drug: Brimonidine; Drug: Netarsudil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06449352

ZV-24-01

Details and patient eligibility

About

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 .

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

100 participants in 2 patient groups

Netarsudil

Experimental group

Description:

netarsudil 0.02%

Treatment:

Drug: Netarsudil

Brimonidine

Active Comparator group

Description:

brimonidine 0.1%

Treatment:

Drug: Brimonidine