Imaging the Effects of Netarsudil (Rhopressa) on the Trabecular Meshwork in Glaucoma and Ocular Hypertension
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndiana University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Netarsudil Ophthalmic Solution (Rhopressa)
DrugNetarsudil 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.
Artificial Tears (AT)
Other interventionArtificial 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Netarsudil (Rhopressa)Active comparator 1 intervention
Group B: Placebo (Artificial Tears)Placebo comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline to 14-21 days after initiation of treatmentSecondary outcomes
1
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.
Time frame
Baseline to 14-21 days after initiation of treatment2
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.
Time frame
Baseline to 14-21 days after initiation of treatmentOther outcomes
1
Change in Schlemm's Canal Diameter
Mean change in Schlemm's canal cross-sectional diameter measured using AS-OCT and OCT gonioscopy.
Time frame
Baseline to 14-21 days after initiation of treatment2
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.
Time frame
Baseline and 14-21 days after initiation of treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Indiana University
Lead sponsor
Alcon Research
Collaborator
Source ClinicalTrials.gov