Effect of Netarsudil vs Brimonidine in NTG Patients on Latanoprost

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-13

Study Completion Date

2025-09-22

Brief Summary

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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 .

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Detailed Description

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Conditions

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Normal Tension Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Netarsudil

netarsudil 0.02%

Group Type EXPERIMENTAL

Netarsudil

Intervention Type DRUG

netarsudil 0.02%

Brimonidine

brimonidine 0.1%

Group Type ACTIVE_COMPARATOR

Brimonidine

Intervention Type DRUG

brimonidine 0.1%

Interventions

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Netarsudil

netarsudil 0.02%

Intervention Type DRUG

Brimonidine

brimonidine 0.1%

Intervention Type DRUG

Eligibility Criteria

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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

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes