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
Overview
- Phase
- Phase 3
- Intervention
- Netarsudil (AR-13324) Ophthalmic Solution 0.02%
- Conditions
- Open-angle Glaucoma
- Sponsor
- Aerie Pharmaceuticals
- Enrollment
- 718
- Locations
- 1
- Primary Endpoint
- Intraocular Pressure (IOP)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
AR-13324 Ophthalmic Solution 0.02%
Netarsudil 0.02% ophthalmic solution
Intervention: Netarsudil (AR-13324) Ophthalmic Solution 0.02%
PG324 Ophthalmic Solution 0.02%/0.005%
Fixed combination of netarsudil 0.02%, latanoprost 0.005% ophthalmic solution
Intervention: PG324 Ophthalmic Solution 0.02%/0.005%
Latanoprost Ophthalmic Solution 0.005%
Latanoprost 0.005% ophthalmic solution
Intervention: Latanoprost Ophthalmic Solution 0.005%
Outcomes
Primary Outcomes
Intraocular Pressure (IOP)
Time Frame: 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)
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.
Secondary Outcomes
- Extent of Exposure(12 months)