Double-masked Study of PG324 Ophthalmic Solution in Patients 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 PG324 Ophthalmic Solution compared to Netarsudil (AR-13324) Ophthalmic Solution and Latanoprost Ophthalmic Solution. Following completion of the Month 12 study visit procedures, subjects will be offered the opportunity to participate in a 2-month observational (i.e., non-interventional) trial extension.

Official Title
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A Prospective, Double-masked, Randomized, Multi-center, Active-controlled, Parallel-group 12-month Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution Compared to AR-13324 Ophthalmic Solution, 0.02% and Latanoprost Ophthalmic Solution, 0.005% in Subjects With Elevated Intraocular Pressure

Conditions
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Open-angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: PG324 Ophthalmic Solution 0.02%/0.005%
* Drug: Netarsudil (AR-13324) Ophthalmic Solution 0.02%
* Drug: Latanoprost Ophthalmic Solution 0.005%


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 Unmedicated intraocular pressure >20mmHg and <36mmHg in both eyes at 2 qualification visits. Both eyes had to qualify at all qualification visits Corrected visual acuity equivalent to 20/200 Snellen or better 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 ≥36mmHg 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 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 on 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PG324 Ophthalmic Solution 0.02%/0.005%<br>Fixed combination of netarsudil 0.02%, latanoprost 0.005% ophthalmic solution | Drug: PG324 Ophthalmic Solution 0.02%/0.005%<br>* 1 drop once daily (QD), in the evening (PM) in both eyes (OU)<br>|
| Active Comparator: AR-13324 Ophthalmic Solution 0.02%<br>Netarsudil 0.02% ophthalmic solution | Drug: Netarsudil (AR-13324) Ophthalmic Solution 0.02%<br>* 1 drop once daily (QD), in the evening (PM) in both eyes (OU)<br>|
| Active Comparator: Latanoprost Ophthalmic Solution 0.005%<br>Latanoprost 0.005% ophthalmic solution | Drug: Latanoprost Ophthalmic Solution 0.005%<br>* 1 drop once daily (QD), in the evening (PM) in both eyes (OU)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure (IOP) | The primary efficacy variable was mean IOP at 08:00, 10:00 and 16:00 hours at Day 15, Day 43 and Day 90, as measured by Goldmann applanation tonometry. Secondary analysis were conducted as a part of safety measurements to month 12 on treatment. | Primary efficacy endpoint measured for 3 months (data collected at 08:00, 10:00 and 16:00 hours at Day 15, Day 43 and Day 90) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of Exposure | Exposure to study medication in days for all treatment groups | 12 months |