Study Assessing Safety and Efficacy of PG324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure

Study Overview
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Brief Summary
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To evaluate the ocular hypotensive efficacy of PG324 ophthalmic solution relative to its individual components in patients with open angle glaucoma or ocular hypertension.

Official Title
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A Double-masked, Randomized, Controlled Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution, 0.01% and PG324 Ophthalmic Solution, 0.02%, Compared to AR-13324 Ophthalmic Solution, 0.02% and Latanoprost Ophthalmic Solution, 0.005% in Patients With Elevated Intraocular Pressure

Conditions
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Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: PG324 Ophthalmic Solution 0.01%
* Drug: PG324 Ophthalmic Solution 0.02%
* 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 greater. Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT) 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: Ophthalmic: Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles. Intraocular pressure >36 mmHg Known hypersensitivity to any component of the formulation, latanoprost, or to topical anesthetics. Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s) Refractive surgery in study eye(s) Ocular trauma within the six months prior to screening, or ocular surgery or laser treatment within the three months prior to screening. Evidence of ocular infection and inflammation Clinically significant ocular disease, which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications for one month is not judged safe Central corneal thickness greater then 600 μm Any abnormality preventing reliable applanation tonometry of either eye Systemic: Clinically significant abnormalities (as determined by the investigator) in laboratory tests at screening. Clinically significant systemic disease Participation in any investigational study within 30 days prior to screening Changes in systemic medication Women of childbearing 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PG324 Ophthalmic Solution 0.01%<br>Netarsudil 0.01%, Latanoprost 0.005% fixed combination ophthalmic solution | Drug: PG324 Ophthalmic Solution 0.01%<br>* 1 drop in the evening (PM), once daily (QD), both eyes (OU)<br>|
| Experimental: PG324 Ophthalmic Solution 0.02%<br>Netarsudil 0.02%, Latanoprost 0.005% fixed combination ophthalmic solution | Drug: PG324 Ophthalmic Solution 0.02%<br>* 1 drop in the evening (PM), once daily (QD), both eyes (OU)<br>|
| Active Comparator: Netarsudil (AR-13324) Ophthalmic Solution 0.02%<br>Netarsudil 0.02% ophthalmic solution | Drug: Netarsudil (AR-13324) Ophthalmic Solution 0.02%<br>* 1 drop in the evening (PM), once daily (QD), 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 in the evening (PM), once daily (QD), 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 endpoint was the mean diurnal IOP across subjects within treatment group at Day 29. | Study treatment was administered for 28 days, and outcome measures collected on Day 29 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AR13324, Open Angle Glaucoma, Ocular Hypertension, Intraocular Pressure, PG324