Adaptive Optics Gonioscopy In Vivo Imaging of the Effects of Rhopressa on the Trabecular Meshwork in Patients with Ocular Hypertension or Glaucoma
Study on Effects of Investigational Eye Drops on Eye Pressure and Structure
Brett Joseph King
Primary Investigator
Brief description of study
This is a prospective, randomized, single-masked study investigating the mechanism of action of Rhopressa (netarsudil) topical ophthalmic medication compared to a placebo drop (artificial tear).
Detailed description of study
Subjects will be randomized to either an active medication or placebo eye drop in a 2 to 1 randomization (33 to active agent and 17 to placebo). Subjects will be imaged using an adaptive optics ophthalmoscope with a gonioscopy lens to visualize the trabecular meshwork lamellae (primary outcome) and endothelial cells (exploratory outcome). Measurements of spacing between lamellae will be and endpoint of the study. Trabecular meshwork endothelial cells will be counted on subjects as an exploratory outcome measure.
AS-OCT and OCT gonioscopy will also be performed for the secondary outcome of trabecular meshwork height and width, and the exploratory outcome of Schlemm’s canal diameter. Measurements to be compared between treatment and placebo groups will include trabecular meshwork height and width as well as Schelmm’s canal diameter. Artificial tears will be used as a placebo which is not expected to lower eye pressure or make any structural changes to enhance drainage. These measurements will be considered secondary and exploratory but are clinically applicable measurements, since most clinics do not have access to adaptive optics, but do have access to clinical OCT systems.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Ocular Hypertension, Glaucoma
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Age: 18 years or above
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Gender: All
Inclusion Criteria
• All adult (≥ 18 year old) subjects will have been diagnosed with either ocular hypertension or open-angle glaucoma and have had an eye exam within the past year.
• Subjects with glaucoma will have structural (optic nerve and/or retinal nerve fiber layer) and functional (visual field testing) consistent with the diagnosis of glaucoma.
• Subjects with ocular hypertension will have had an eye exam within the past year.
• Subjects will have corrected acuity of 20/100 or better.
• Subjects with an open angle as visualized via AS-OCT and gonioscopy
• Naïve to medication subjects or post washout IOP between 18 and 34 mmHg
Exclusion Criteria
• Subjects known to be unable to tolerate netarsudil ophthalmic solution.
• Subjects with scarring of the cornea or active corneal disease that would prevent imaging.
• Subjects unable to tolerate gonioscopy.
• Female subjects of childbearing age will need to be sterile or using a preventative option to pregnancy during the study.
• Any subject the investigator feels is too high of a risk for the washout or in which believes cannot finish the study.
This study investigates the effects of an investigational eye drop on patients with ocular hypertension or glaucoma. Ocular hypertension means having high pressure in the eye, and glaucoma is a condition that can damage the optic nerve, often due to high eye pressure. The investigational eye drop will be compared to a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine.
Participants will receive either the investigational eye drop or a placebo. Researchers will use special imaging tools to look at parts of the eye called the trabecular meshwork and endothelial cells. They will measure different features of the eye to understand how the investigational eye drop works compared to the placebo.
- Who can participate: Adults 18 years and older with ocular hypertension or open-angle glaucoma are eligible. Participants must have had an eye exam within the past year and meet specific eye health criteria. Women of childbearing age must use birth control during the study.
- Study details: Participants will be randomly assigned to receive either the investigational eye drop or a placebo. Special imaging will be used to examine the eye's structures. The placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine.
Interested in the study?
This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.
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