Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension

Study Overview
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Brief Summary
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To evaluate ocular hypotensive efficacy and safety of Netarsudil (AR-13324) Ophthalmic Solution compared to Timolol Maleate Ophthalmic Solution.

Official Title
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A Double-masked, Randomized, Multi-center, Active-controlled, Parallel Group, 6-month Study With a 3-month Interim Analysis Assessing the Ocular Hypotensive Efficacy and Safety of AR-13324 Ophthalmic Solution, 0.02% QD Compared to Timolol Maleate Ophthalmic Solution, 0.5% BID in Patients With Elevated Intraocular Pressure

Conditions
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Open-angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: AR-13324 Ophthalmic Solution 0.02%
* Drug: Timolol Maleate Ophthalmic Solution 0.5% BID
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Diagnosis of open angle glaucoma or ocular hypertension in both eyes Post-washout intraocular pressure >20mmHg and <30mmHg in 1 or both eyes at 2 qualification visits Corrected visual acuity equivalent to 20/200 Able to give informed consent and follow study instructions Exclusion Criteria: Clinically significant ocular disease Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure or narrow angles Unmedicated intraocular pressure ≥30mmHg Use of more than 2 ocular hypotensive medications within 30 days of screening Known hypersensitivity to any component of the formulation Previous glaucoma surgery or refractive surgery Ocular trauma within 6 months prior to screening Any ocular surgery or non-refractive laser treatment within 3 months prior to screening Recent or current ocular infection or inflammation in either eye Used ocular medication in either eye of any kind within 30 days of screening Mean central corneal thickness >620µm at screening Any abnormality preventing reliable applanation tonometry of either eye Clinically significant abnormalities in lab tests at screening Known hypersensitivity or contraindication to beta-adrenoceptor antagonists Clinically significant systemic disease Participation in any investigational study within 60 days prior to screening Used any systemic medication that could have a substantial effect in intraocular pressure within 30 days prior to screening Women who are pregnant, nursing, planning a pregnancy or not using a medically acceptable form of birth control

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: AR-13324 Ophthalmic Solution 0.02% & placebo<br>1 drop AR-13324 in the evening (PM) & 1 drop placebo in the morning (AM) in both eyes (OU) | Drug: AR-13324 Ophthalmic Solution 0.02%<br>* 1 drop once daily (QD), PM, OU<br>* Other names: Netarsudil;Other: Placebo<br>* 1 drop QD, AM, OU<br>|
| Active Comparator: Timolol Maleate Ophthalmic Solution 0.5% BID<br>1 drop twice daily (BID) in the morning (AM) & evening (PM) in both eyes (OU) | Drug: Timolol Maleate Ophthalmic Solution 0.5% BID<br>* 1 drop BID, AM/PM, OU<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP (Intraocular Pressure) | The primary efficacy outcome is mean IOP | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of Exposure | Exposure to study medication in days for all treatment groups | 6 months |