Effect of Netarsudil vs Brimonidine in NTG Patients on Latanoprost

Normal Tension Glaucoma Clinical Trial

Official title:

Effect of the Addition of Netarsudil 0.02% vs. Brimonidine 0.1% in Normal Tension Glaucoma Patients Currently on Latanoprost 0.005%

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06449352
• Other study ID #: ZV-24-01
• Status: Recruiting
• Phase: Phase 4
• Start date: June 30, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: Westlake Eye Specialists
• Contact: Zarmeena Vendal, MD
• Phone: 512-472-4011
• Email: zvendal[@]westlakeeyes.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Low Tension Glaucoma
• Normal Tension Glaucoma

Intervention

Drug:
• Netarsudil
netarsudil 0.02%
• Brimonidine
brimonidine 0.1%

Locations

Country	Name	City	State
United States	Westlake Eye Specialists - Austin Office	Austin	Texas
United States	Westlake Eye Specialists - Killeen Office	Killeen	Texas
United States	Westlake Eye Specialists - Kyle Office	Kyle	Texas
United States	Westlake Eye Specialists - New Braunfels Office	New Braunfels	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Westlake Eye Specialists	Sengi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean diurnal intraocular pressure	Intraocular pressure will be measure at 8am, 12pm, and 4pm	After 6 weeks of treatment
Secondary	Mean intraocular pressure at 8am		After 6 weeks of treatment
Secondary	Mean intraocular pressure at 12pm		After 6 weeks of treatment
Secondary	Mean intraocular pressure at 4pm		After 6 weeks of treatment
Secondary	Percentage of diurnal intraocular pressure reduction	Intraocular pressure will be measure at 8am, 12pm, and 4pm	After 6 weeks of treatment