Normal Tension GlaucomaPhase 4NCT06449352
Effect of Netarsudil vs Brimonidine in NTG Patients on Latanoprost
A Phase 4 study testing Netarsudil and Brimonidine in people with Normal Tension Glaucoma, run by Westlake Eye Specialists at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Normal Tension Glaucoma
- What is being tested?
- Netarsudil and Brimonidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesUnited States
- Study dates
- 13 Jun 2024to 22 Sep 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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 locations and contacts
4 sites in 1 country.
United States4 sites
Westlake Eye Specialists - Austin Office
Austin, Texas, 78746
Westlake Eye Specialists - Killeen Office
Killeen, Texas, 76549
Westlake Eye Specialists - Kyle Office
Kyle, Texas, 78640
Westlake Eye Specialists - New Braunfels Office
New Braunfels, Texas, 78130
About this study
Official title: Effect of the Addition of Netarsudil 0.02% vs. Brimonidine 0.1% in Normal Tension Glaucoma Patients Currently on Latanoprost 0.005%
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 .
- Conditions
- Normal Tension Glaucoma
- Being tested
- Netarsudil, Brimonidine
- Medical subject headings
- Low Tension Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NetarsudilDrug
netarsudil 0.02%
BrimonidineDrug
brimonidine 0.1%
| Study group | Role | What they receive |
|---|---|---|
| Netarsudil | Experimental | netarsudil 0.02% Receives: Drug: Netarsudil |
| Brimonidine | Active comparator | brimonidine 0.1% Receives: Drug: Brimonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean diurnal intraocular pressure
Intraocular pressure will be measure at 8am, 12pm, and 4pm
Measured: After 6 weeks of treatment
Secondary outcomes (4)
Mean intraocular pressure at 8am
Measured: After 6 weeks of treatment
Mean intraocular pressure at 12pm
Measured: After 6 weeks of treatment
Mean intraocular pressure at 4pm
Measured: After 6 weeks of treatment
Percentage of diurnal intraocular pressure reduction
Intraocular pressure will be measure at 8am, 12pm, and 4pm
Measured: After 6 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start13 Jun 2024
- Primary completion22 Sep 2025
- Study completion22 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Tension GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Westlake Eye Specialists
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- Zarmeena Vendal, MD, Principal investigator, Westlake Eye Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449352
- Sponsor's protocol ID
- ZV-24-01
- Status last verified
- Oct 2025
- First submitted
- 3 Jun 2024
- Last updated
- 22 Oct 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Addition of Netarsudil 0.02% vs. Brimonidine 0.1% in Normal Tension Glaucoma Patients Currently on Latanoprost 0.005%
- ClinicalTrials.gov ID
- NCT06449352
- Acronym / sponsor ID
- ZV-24-01
- Conditions
- Normal Tension Glaucoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Westlake Eye SpecialistsUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 22 Sep 2025 (actual)
- Study completion
- 22 Sep 2025 (actual)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Netarsudil | Experimental | Drug: Netarsudilnetarsudil 0.02% |
| Brimonidine | Active comparator | Drug: Brimonidinebrimonidine 0.1% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients 18 years and older
- Diagnosed with normal tension glaucoma based on the following:
- Have been on latanoprost monotherapy for at least 6 weeks
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Netarsudilnetarsudil 0.02% | Drug | Netarsudil |
| Brimonidinebrimonidine 0.1% | Drug | Brimonidine |
Primary outcome
Mean diurnal intraocular pressure
Time frame: After 6 weeks of treatment
Intraocular pressure will be measure at 8am, 12pm, and 4pm
4 secondary outcomes
Mean intraocular pressure at 8am
Time frame: After 6 weeks of treatment
Mean intraocular pressure at 12pm
Time frame: After 6 weeks of treatment
Mean intraocular pressure at 4pm
Time frame: After 6 weeks of treatment
Percentage of diurnal intraocular pressure reduction
Time frame: After 6 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zarmeena Vendal, MD principal investigator
Westlake Eye Specialists
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Netarsudil and Brimonidine in people with Normal Tension Glaucoma, run by Westlake Eye Specialists at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean diurnal intraocular pressure (time frame: After 6 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2025.