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

NCT07588152 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 31537
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Trabecular Meshwork Height

  Baseline to 14-21 days after initiation of treatment

• Change in Trabecular Meshwork Width

  Baseline to 14-21 days after initiation of treatment

Other Outcomes (2)

• Change in Schlemm's Canal Diameter

  Baseline to 14-21 days after initiation of treatment

• Trabecular Meshwork Endothelial Cell Counts

  Baseline and 14-21 days after initiation of treatment

Study Arms (2)

Netarsudil (Rhopressa)

ACTIVE COMPARATOR

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)

Placebo (Artificial Tears)

PLACEBO COMPARATOR

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)

Interventions

Netarsudil Ophthalmic Solution (Rhopressa) DRUG

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.

Netarsudil (Rhopressa)

Artificial Tears (AT) OTHER

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.

Placebo (Artificial Tears)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Alcon Research: collaborator

Study Sites (1)

Indiana Universtiy School of Optometry

Bloomington, Indiana, 47405, United States

Location

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Interventions

Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Central Study Contacts

Brett J King, OD

CONTACT

(812) 855-1344; kingbrj@iu.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 14, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)