A Controlled Study of the Aqueous Humor Dynamics of AR-13324 Ophthalmic Solution in Healthy Adult Volunteers

Study Overview
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Brief Summary
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To evaluate the effect of netarsudil (AR-13324) ophthalmic solution on aqueous humor dynamics relative to its placebo.

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: Netarsudil (AR-13324) Ophthalmic Solution
* Drug: Netarsudil (AR-13324) Ophthalmic Solution Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult male or female subjects at least 18 years of age. Local area resident, existing patient or employee of Mayo Clinic. Medically healthy subjects with clinically insignificant screening results. Subjects with two normal (non-diseased) eyes. Intraocular pressure between 14 and 21 mm Hg (inclusive) in each eye at screening. Best-corrected visual acuity in each eye of +0.4 (20/50) or better. Able and willing to give signed informed consent and follow study instructions. Exclusion Criteria: Chronic or acute ophthalmic disease including glaucoma, macular degeneration, uveitis clinically significant cataract. Known hypersensitivity to any component of the formulation or to topical anesthetics. Previous intraocular surgery, retina laser procedures or refractive surgery. Myopia greater than -4.00 D spherical equivalent. Hyperopia greater than +2.00 D spherical equivalent. Ocular trauma within the past six months. Evidence of ocular infection, inflammation, cystoid macular edema, clinically significant blepharitis or conjunctivitis, or a history of herpes simplex keratitis. Ocular medication of any kind within 30 days of screening. Any abnormality preventing reliable applanation tonometry of either eye. Central corneal thickness less than 500 μm or greater than 600 μm. Cannot demonstrate proper delivery of the eye drop. Clinically significant systemic disease which might interfere with the study. Participation in any investigational study within the past 30 days prior to screening. Use of systemic medication that could have a substantial effect on intraocular pressure within 30 days prior to screening, or anticipated during the study. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a physician-supervised form of birth control for at least the last 2 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Netarsudil (AR-13324) Ophthalmic Solution | Drug: Netarsudil (AR-13324) Ophthalmic Solution<br>* Topical ophthalmic solution<br>|
| Placebo Comparator: Placebo<br>Netarsudil (AR-13324) Ophthalmic Solution Placebo | Drug: Netarsudil (AR-13324) Ophthalmic Solution Placebo<br>* Ophthalmic solution once a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in aqueous humor flow rate measured by non-contact fluorophotometer | Aqueous humor flow rate measured by non-contact fluorophotometer; change from baseline | Day 1 compared to Day 8 | 
| Change in outflow facility measured non-invasively by tonography | Outflow facility measured non-invasively by tonography; change from baseline | Day 1 compared to Day 8 | 
| Change in episcleral venous pressure measured non-invasively by slit-lamp exam | Episcleral venous pressure measured non-invasively by slit-lamp exam; change from baseline | Day 1 compared toDay 8 | 
| Change in visual acuity measured using eye chart | Visual acuity measured using eye chart; change from baseline | Day 1 compared to Day 8 | 
| Change in biomicroscopy exam using non-invasive slit-lamp to evaluate cornea, conjunctiva, and anterior chamber of eye | Biomicroscopy exam using non-invasive slit-lamp to evaluate cornea, conjunctiva, and anterior chamber of eye; change from baseline | Day 1 compared to Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Number of participants with adverse events | Number of participants with adverse events as a measure of safety and tolerability | Day 1 compared to Day 8 |