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

Aerie Pharmaceuticals1 site in 1 country750 target enrollmentFebruary 2016

ConditionsOpen-angle Glaucoma Ocular Hypertension

InterventionsPG324 Ophthalmic Solution 0.02%/0.005%Netarsudil (AR-13324) ophthalmic solution 0.02%Latanoprost ophthalmic solution 0.005%

DrugsPG324 Ophthalmic Solution 0.02%/0.005%Netarsudil (AR-13324) ophthalmic solution 0.02%Latanoprost ophthalmic solution 0.005%

Overview

Phase: Phase 3
Intervention: PG324 Ophthalmic Solution 0.02%/0.005%
Conditions: Open-angle Glaucoma
Sponsor: Aerie Pharmaceuticals
Enrollment: 750
Locations: 1
Primary Endpoint: Intraocular Pressure (IOP)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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%

Registry

clinicaltrials.gov

Start Date

February 2016

End Date

March 2017

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Aerie Pharmaceuticals

Responsible Party

Sponsor

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