Nocturnal/Diurnal Intraocular Pressure-Lowering Effect of Netarsudil Ophthalmic Solution

Study Overview
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Brief Summary
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To evaluate effect of Netarsudil Ophthalmic Solution 0.02% on Nocturnal and Diurnal Intraocular Pressure.

Official Title
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A Double-masked, Randomized, Placebo-controlled Study of the Nocturnal and Diurnal IOP-lowering Effect of Netarsudil Ophthalmic Solution 0.02% in Habitual Positions Over a 24-hour Period.

Conditions
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Ocular Hypertension, Open Angle Glaucoma

Intervention / Treatment
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* Drug: Netarsudil ophthalmic solution 0.02%
* Other: Netarsudil Ophthalmic Solution Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older. Ocular hypertension or open-angle glaucoma in both eyes. Unmedicated intraocular pressure > 17 mmHg in one or both eyes and < 30 mmHg in both eyes. Corrected visual acuity in each eye equivalent to 20/200 or better. Able and willing to give signed informed consent and follow study instructions. Exclusion Criteria: Glaucoma with pseudoexfoliation or pigment dispersion component, history of angle closure, narrow angles. Intraocular pressure ≥ 30 mmHg. Use of ocular medications within 30 days. Known hypersensitivity to any component of the test formulations or to medications used routinely during a clinical eye examination. Previous eye surgery (other than cataract). Ocular trauma within 6 months. Clinically significant ocular disease that might interfere with the study. Central corneal thickness greater than 620 µm.

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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No

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: Netarsudil Ophthalmic Solution 0.02%<br>1 drop in each eye (OU) daily | Drug: Netarsudil ophthalmic solution 0.02%<br>* Once daily in both eyes (OU) in the evening (PM) for 7 days<br>* Other names: AR-13324;|
| Placebo Comparator: Netarsudil Ophthalmic Solution Vehicle<br>1 drop in each eye (OU) daily | Other: Netarsudil Ophthalmic Solution Vehicle<br>* Once daily in both eyes (OU) in the evening (PM) for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Intraocular Pressure (IOP) Over Nocturnal Time Period | The primary efficacy endpoint was the mean change from baseline in mean nocturnal IOP (defined as the mean of the 4 nocturnal time points: 21:00, 00:00, 03:00, and 06:00 hours) on Day 8/Day 9 | Assessed over 24 hours at 9 pm, midnight, 3 am and 6 am on days 1/2 and 8/9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability |  | 7 days (day 1/2 to day 8/9) |