NCT06449352

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 10, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

June 13, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2025

Completed
Last Updated

October 22, 2025

Status Verified

October 1, 2025

Enrollment Period

1.3 years

First QC Date

June 3, 2024

Last Update Submit

October 21, 2025

Conditions

Normal Tension Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Mean diurnal intraocular pressure

    Intraocular pressure will be measure at 8am, 12pm, and 4pm

    After 6 weeks of treatment

Secondary Outcomes (4)

  • 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

    After 6 weeks of treatment

Study Arms (2)

Netarsudil

EXPERIMENTAL

netarsudil 0.02%

Drug: Netarsudil

Brimonidine

ACTIVE COMPARATOR

brimonidine 0.1%

Drug: Brimonidine

Interventions

NetarsudilDRUG

netarsudil 0.02%

Netarsudil
BrimonidineDRUG

brimonidine 0.1%

Brimonidine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Westlake Eye Specialists - Austin Office

Austin, Texas, 78746, United States

Location

Westlake Eye Specialists - Killeen Office

Killeen, Texas, 76549, United States

Location

Westlake Eye Specialists - Kyle Office

Kyle, Texas, 78640, United States

Location

Westlake Eye Specialists - New Braunfels Office

New Braunfels, Texas, 78130, United States

Location

MeSH Terms

Conditions

Low Tension Glaucoma

Interventions

netarsudilBrimonidine Tartrate

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye DiseasesOptic Nerve Diseases

Intervention Hierarchy (Ancestors)

QuinoxalinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Zarmeena Vendal, MD

    Westlake Eye Specialists

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2024

First Posted

June 10, 2024

Study Start

June 13, 2024

Primary Completion

September 22, 2025

Study Completion

September 22, 2025

Last Updated

October 22, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(4)