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Prostaglandin Analog

Group 2: Normal tension glaucoma subjects with thick corneas for Glaucoma (NTG Trial)

Phase 4
Waitlist Available
Research Sponsored by Salus University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post-treatment
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

Glaucoma is the second leading cause of blindness and the first leading cause of irreversible vision loss worldwide. The intraocular pressure (IOP) is the only modifiable risk factor for all the spectrum of glaucoma. Reducing IOP in glaucoma increases the likelihood of preventing progression of the disease and preserving the quality of life of the patient. Although prostaglandin analogs (PGAs) and prostamides (PMs) are de facto first-line treatment options for managing glaucoma, it is a common clinical experience to see their treatment effects plateau to a level beyond which no clinically significant IOP reduction is likely. It is also common to find minimal IOP treatment effects in the following conditions: patients with normal tension glaucoma (NTG), patients with thicker central corneal thickness (CCT), and patients with higher levels of corneal hysteresis (CH). CH is a possible proxy for the ability of the scleral tissue around the optic nerve to dissipate energy away from the optic nerve fibers. Netarsudil, a rho-kinase inhibitor was recently approved by the FDA for the treatment of glaucoma and ocular hypertension. There is a paucity of research on the efficacy of netarsudil in patients with NTG, thicker CCT, and higher levels of CH. This study aims to investigate the above issues by evaluating the efficacy of netarsudil and bimatoprost in subjects with NTG, thicker corneas, and higher levels of CH. Hypotheses * Netarsudil will have non-inferior efficacy compared to Bimatoprost in treating NTG. * Corneal thickness and corneal hysteresis will reduce the efficacy of netarsudil similar to bimatoprost in NTG. * Netarsudil will change corneal thickness and corneal hysteresis similar to bimatoprost in NTG.

Eligible Conditions
  • Glaucoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Post-treatment IOP
Secondary study objectives
Post-treatment IOP change by CCT
Post-treatment IOP change by CH
Post-treatment change in CCT
+1 more

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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
Group I: Group 2: Normal tension glaucoma subjects with thick corneasExperimental Treatment2 Interventions
NTG subjects with CCT \> 540 nm will be randomized to receive either netarsudil or bimatoprost.
Group II: Group 1: Normal tension glaucoma subjects with thin corneasExperimental Treatment2 Interventions
NTG subjects with CCT ≤ 540 nm will be randomized to receive either netarsudil or bimatoprost.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Netarsudil
FDA approved
Bimatoprost
FDA approved

Find a Location

Who is running the clinical trial?

Salus UniversityLead Sponsor
14 Previous Clinical Trials
862 Total Patients Enrolled
Jingyun Wang, Ph.DStudy DirectorSalus University
~27 spots leftby Nov 2025