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Rho Kinase Inhibitor
Netarsudil vs Brimonidine for Normal Tension Glaucoma
Phase 4
Recruiting
Led By Zarmeena Vendal, MD
Research Sponsored by Westlake Eye Specialists
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Be older than 18 years old
Must not have
Other forms of secondary glaucoma
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 6 weeks of treatment
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial will compare the effects of adding netarsudil or brimonidine to the eye drops of patients with glaucoma who are already using latanoprost. The study will measure changes
Who is the study for?
This trial is for patients with Normal Tension Glaucoma (NTG) who are already using latanoprost. Participants should be stable on their current treatment and available for a screening visit and at least one follow-up. Specific inclusion or exclusion criteria were not provided.
What is being tested?
The study compares the effect of adding netarsudil versus brimonidine to NTG patients' existing latanoprost regimen on intraocular pressure (IOP). It's a randomized, multicenter trial where participants won't know which additional medication they're receiving.
What are the potential side effects?
Possible side effects of netarsudil include eye redness, cornea deposits, and allergy symptoms. Brimonidine may cause dry mouth, fatigue, or allergic reactions. Side effects can vary based on individual patient response.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have normal tension glaucoma and have been on latanoprost for 6 weeks.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a type of glaucoma that is not primary.
Select...
I have a specific type of glaucoma not caused by high eye pressure alone.
Select...
I am an adult without cognitive impairments and not critically ill.
Select...
I am allergic to or have not responded to brimonidine or netarsudil.
Select...
I have had surgery for glaucoma.
Select...
My eye swelling has not improved for 3 months or more.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after 6 weeks of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 6 weeks of treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean diurnal intraocular pressure
Secondary study objectives
Percentage of diurnal intraocular pressure reduction
Side effects data
From 2019 Phase 3 trial • 120 Patients • NCT0324803723%
Ocular irritation considered related to study drug use
21%
Air re-injection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Netarsudil
Placebo
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: NetarsudilExperimental Treatment1 Intervention
netarsudil 0.02%
Group II: BrimonidineActive Control1 Intervention
brimonidine 0.1%
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Netarsudil
2017
Completed Phase 3
~120
Find a Location
Who is running the clinical trial?
Westlake Eye SpecialistsLead Sponsor
SengiIndustry Sponsor
25 Previous Clinical Trials
1,913 Total Patients Enrolled
1 Trials studying Glaucoma
54 Patients Enrolled for Glaucoma
Zarmeena Vendal, MDPrincipal InvestigatorWestlake Eye Specialists
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