Double-masked Study of PG324 Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
To evaluate ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to netarsudil (AR-13324) ophthalmic solution 0.02% and latanoprost ophthalmic solution 0.005%

Official Title
-----------------
A Prospective, Double-masked, Randomized, Multi-center, Active Controlled, Parallel-group, 3-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
-----------------
Open-angle Glaucoma, Ocular Hypertension

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older (19 years of age or older in Canada) Diagnosis of open angle glaucoma (OAG) or ocular hypertension(OHT) in both eyes Unmedicated intraocular pressure >20mmHg and <36mmHg in both eyes at 2 qualification visits Best corrected visual acuity (BCVA) equivalent to 20/200 Snellen or better Able to give informed consent and follow study instructions Exclusion Criteria: Ophthalmic: Clinically significant ocular disease Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure or narrow angles Unmedicated intraocular pressure ≥36mmHg in either eye or use of more than 2 ocular hypotensive medications within 30 days of screening Known hypersensitivity to any component of the formulation or latanoprost 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 Use of ocular medication in either eye of any kind within 30 days of screening and throughout of the study Mean central corneal thickness >620µm at screening in either eye Any abnormality preventing reliable applanation tonometry of either eye Systemic: Clinically significant abnormalities in lab tests at screening Clinically significant systemic disease Participation in any investigational study within 60 days prior to screening Systemic medication that could have had a substantial effect on IOP within 30 days prior to screening, or anticipated to be used during the study Women of childbearing potential who were pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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 daily in the evening (PM) in 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 daily 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 daily in the evening (PM) in both eyes (OU)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure (IOP) | Mean intraocular pressure(IOP) at 08:00, 10:00 and 16:00 hours, at Day 15, Day 43 and Day 90, as measured by Goldmann applanation tonometry. | 3 months |