Study of Netarsudil Ophthalmic Solution in Japanese/Japanese-American Subjects With Open-angle Glaucoma or Ocular Hypertension

Study Overview
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Brief Summary
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To test the safety and effectiveness of AR-13324 0.02% and 0.04% ophthalmic solution relative to placebo in Japanese/Japanese-American subjects with open-angle glaucoma or ocular hypertension in US.

Official Title
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A Prospective, Double-masked, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Assessing the Safety and Ocular Hypotensive Efficacy and Optimum Concentration to be Used Clinically of Netarsudil Ophthalmic Solution in Japanese/Japanese-American Subjects With Open-angle Glaucoma or Ocular Hypertension in the United States

Conditions
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Primary Open Angle Glaucoma or Ocular Hypertension

Intervention / Treatment
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* Drug: AR-13324 Ophthalmic Solution 0.02%
* Drug: AR-13324 Ophthalmic Solution 0.04%
* Drug: AR-13324 Ophthalmic Solution Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be 18 years or older Be of Japanese ethnicity within the 2nd generation defined as (a) 1st generation born in Japan, immigrated to US and (b) 2nd generation - parents are 1st generation and patient was born in US as an American citizen Diagnosis of open-angle glaucoma or ocular hypertension in both eyes Medicated intraocular pressure >/= 15 mmHg and < 30 mmHg in both eyes at screening OAG eyes - unmedicated IOP >/= 15 mmHg and < 35 mmHg at 2 qualification visits at 08:00, 10:00 and 16:00 OHT eyes - unmedicated IOP >/= 22 mmHg and < 35mmHg at 08:00, 10:00 and 16:00 Best corrected visual acuity + 1.0 logMAR or better by ETDRS in each eye Able to give signed informed consent and follow instructions Exclusion Criteria: Clinically significant ocular disease Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma or narrow angles Intraocular pressure >/=35 mmHg in either eye Ocular hyperemia score of moderate (+2) at qualification visit #2 Previous glaucoma intraocular surgery Refractive surgery in either eye Ocular injury within 6 months prior to screening or ocular surgery or non-refractive laser treatment within 3 months prior to screening Recent or current ocular infection or inflammation in either eye Use of ocular medication in either eye of any kind within 30 days of screening and throughout the study Mean central corneal thickness > 620 µm in either eye Any abnormality preventing reliable applanation tonometry of either eye Known hypersensitivity to benzalkonium chloride or excipients of netarsudil ophthalmic solution Clinically significant abnormalities in screening lab tests Clinically significant systemic disease that might interfere with the study Participated in any investigational study within 30 days prior to screening Systemic medication that could have a substantial effect on IOP within 30 days prior to screening or anticipated during the study Women of child-bearing potential 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AR-13324 Ophthalmic Solution 0.02%<br>Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days | Drug: AR-13324 Ophthalmic Solution 0.02%<br>* Administered to each eye, once daily (QD) in the evening (PM) for 28 days<br>|
| Experimental: AR-13324 Ophthalmic Solution 0.04%<br>Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days | Drug: AR-13324 Ophthalmic Solution 0.04%<br>* Administered to each eye, once daily (QD) in the evening (PM) for 28 days<br>|
| Placebo Comparator: Placebo Comparator<br>Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days | Drug: AR-13324 Ophthalmic Solution Placebo<br>* Administered to each eye, once daily (QD) in the evening (PM) for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Diurnal IOP (Intraocular Pressure) (mmHg) | Mean diurnal intraocular pressure (IOP) at week 4, measured by Goldman Applanation Tonometry (GAT). | 28 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of Exposure | Exposure to study medication in days for all treatment groups | 28 Days |