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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brett J King, OD | Contact | (812) 855-1344 | kingbrj@iu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana Universtiy School of Optometry | Recruiting | Bloomington | Indiana | 47405 | United States |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D009883 | Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| 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. |
|
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 |
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 |
| D045506 |
| Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |