Clinical trial NCT06449352: Effect of Netarsudil vs Brimonidine in NTG Patients on Latanoprost
Official title: Effect of the Addition of Netarsudil 0.02% vs. Brimonidine 0.1% in Normal Tension Glaucoma Patients Currently on Latanoprost 0.005%
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Normal Tension Glaucoma
Lead sponsor: Westlake Eye Specialists
Sponsor class: OTHER
Collaborators: name: Sengi
First posted: 2024-06-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 .


Eligibility criteria: 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.

Primary outcomes:
measure: Mean diurnal intraocular pressure
timeFrame: After 6 weeks of treatment
Secondary outcomes:
measure: Mean intraocular pressure at 8am
timeFrame: After 6 weeks of treatment
measure: Mean intraocular pressure at 12pm
timeFrame: After 6 weeks of treatment
measure: Mean intraocular pressure at 4pm
timeFrame: After 6 weeks of treatment
measure: Percentage of diurnal intraocular pressure reduction
timeFrame: After 6 weeks of treatment
Other outcomes:
Locations:
city: Austin
country: United States
facility: Westlake Eye Specialists - Austin Office
state: Texas
city: Killeen
country: United States
facility: Westlake Eye Specialists - Killeen Office
state: Texas
city: Kyle
country: United States
facility: Westlake Eye Specialists - Kyle Office
state: Texas
city: New Braunfels
country: United States
facility: Westlake Eye Specialists - New Braunfels Office
state: Texas
Study officials:
affiliation: Westlake Eye Specialists
name: Zarmeena Vendal, MD
role: PRINCIPAL_INVESTIGATOR
References: