Imaging the Effects of Netarsudil (Rhopressa) on the Trabecular Meshwork in Glaucoma and Ocular Hypertension

Adaptive Optics Gonioscopy In Vivo Imaging of the Effects of Rhopressa on the Trabecular Meshwork in Patients With Ocular Hypertension or Glaucoma

This study evaluates the effects of netarsudil (Rhopressa) on the trabecular meshwork in subjects with ocular hypertension or open-angle glaucoma. Participants will be randomized to receive either netarsudil or placebo (artificial tears). High-resolution imaging using adaptive optics gonioscopy, anterior segment optical coherence tomography (AS-OCT), and OCT gonioscopy will be performed at baseline and after approximately 14 days of treatment. The primary objective is to assess changes in trabecular meshwork lamellae spacing, with secondary measures including trabecular meshwork height, width, and Schlemm's canal diameter.

Study Overview

• Status: Recruiting
• Conditions: Ocular Hypertension; Glaucoma
• Intervention / Treatment: Drug: Netarsudil Ophthalmic Solution (Rhopressa); Other: Artificial Tears (AT)

Detailed Description

Glaucoma is a leading cause of irreversible blindness and is characterized by progressive optic neuropathy. A major modifiable risk factor is elevated intraocular pressure, which is largely regulated by aqueous humor outflow through the trabecular meshwork. Netarsudil (Rhopressa), a Rho kinase inhibitor, lowers intraocular pressure in part by increasing trabecular outflow and has been shown in preclinical studies to induce structural changes in trabecular meshwork cells and tissues. However, in vivo human data evaluating these effects remain limited.

This prospective, randomized, single-masked study will enroll approximately 50 subjects with ocular hypertension or open-angle glaucoma. Participants will be randomized in a 2:1 ratio to receive either netarsudil ophthalmic solution or placebo (artificial tears). Subjects may undergo a washout period if currently treated with glaucoma medications.

Imaging will be performed using adaptive optics gonioscopy to visualize trabecular meshwork microstructure, as well as anterior segment optical coherence tomography (AS-OCT) and OCT gonioscopy to assess clinically relevant anatomical parameters. Imaging will occur at baseline and after approximately 14-21 days of treatment.

The primary outcome is the change in trabecular meshwork lamellae spacing. Secondary outcomes include changes in trabecular meshwork height and width. Exploratory outcomes include Schlemm's canal diameter and trabecular meshwork endothelial cell counts. These measurements aim to provide in vivo evidence of the structural effects of netarsudil on the aqueous outflow pathway and improve understanding of its mechanism of action in humans.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Brett J King, OD; Phone Number: (812) 855-1344; Email: kingbrj@iu.edu

Study Locations

• United States
  • Indiana
    • Bloomington, Indiana, United States, 47405
      • Recruiting
      • Indiana Universtiy School of Optometry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18 years or older
• Diagnosis of ocular hypertension or open-angle glaucoma
• Eye examination within the past year
• For glaucoma subjects: structural (optic nerve and/or retinal nerve fiber layer) and functional (visual field) findings consistent with glaucoma
• Best-corrected visual acuity of 20/100 or better
• Open anterior chamber angle as confirmed by gonioscopy and anterior segment optical coherence tomography (AS-OCT)
• Intraocular pressure between 18 and 34 mmHg (treatment-naïve or after washout, if applicable)

Exclusion Criteria:

• Known intolerance to netarsudil ophthalmic solution
• Corneal scarring or active corneal disease that would interfere with imaging
• Inability to tolerate gonioscopy procedures
• Females of childbearing potential who are not using effective contraception or are not sterile
• Any condition that, in the opinion of the investigator, would place the subject at increased risk or interfere with study completion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Netarsudil (Rhopressa); Participants will receive netarsudil ophthalmic solution administered as one drop in the study eye once daily in the evening for approximately 14 days.	Drug: Netarsudil Ophthalmic Solution (Rhopressa); Netarsudil ophthalmic solution is an FDA-approved Rho kinase inhibitor indicated for the treatment of ocular hypertension and open-angle glaucoma. In this study, it will be administered once daily in the evening for approximately 14 days.
Placebo Comparator: Placebo (Artificial Tears); Participants will receive artificial tears administered as one drop in the study eye once daily in the evening for approximately 14 days.	Other: Artificial Tears (AT); Artificial tears will be used as a placebo control and administered once daily in the evening for approximately 14 days. These drops are not expected to lower intraocular pressure or alter trabecular meshwork structure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Trabecular Meshwork Lamellae Spacing	Mean change in trabecular meshwork lamellae spacing measured using adaptive optics gonioscopy. Measurements will be obtained from baseline (after washout if applicable) and compared to measurements after treatment.	Baseline to 14-21 days after initiation of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Trabecular Meshwork Height	Mean change in trabecular meshwork height measured using anterior segment optical coherence tomography (AS-OCT) and OCT gonioscopy. Height is defined as the distance between the scleral spur and Schwalbe's line.	Baseline to 14-21 days after initiation of treatment
Change in Trabecular Meshwork Width	Mean change in trabecular meshwork width measured using AS-OCT and OCT gonioscopy. Width is defined as the thickness of the trabecular meshwork from the inner wall of Schlemm's canal to the inner surface of the trabecular meshwork.	Baseline to 14-21 days after initiation of treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Schlemm's Canal Diameter	Mean change in Schlemm's canal cross-sectional diameter measured using AS-OCT and OCT gonioscopy.	Baseline to 14-21 days after initiation of treatment
Trabecular Meshwork Endothelial Cell Counts	Trabecular meshwork endothelial cell counts measured using adaptive optics gonioscopy. Cell counts will be assessed at baseline and may be compared between groups and correlated with intraocular pressure changes.	Baseline and 14-21 days after initiation of treatment

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: May 8, 2026
• First Submitted That Met QC Criteria: May 8, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Ocular Hypertension; Ophthalmic Solutions; Pharmaceutical Solutions; Pharmaceutical Preparations; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Solutions; Specialty Uses of Chemicals; Lubricants; Lubricant Eye Drops
• Other Study ID Numbers: 31537

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No