Double-masked Study of PG324 Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Phase 3
Completed
- Conditions
- Ocular HypertensionOpen-angle Glaucoma
- Interventions
- Drug: PG324 Ophthalmic Solution 0.02%/0.005%
- Registration Number
- NCT02558400
- Lead Sponsor
- Aerie Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 718
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AR-13324 Ophthalmic Solution 0.02% Netarsudil (AR-13324) Ophthalmic Solution 0.02% Netarsudil 0.02% ophthalmic solution Latanoprost Ophthalmic Solution 0.005% Latanoprost Ophthalmic Solution 0.005% Latanoprost 0.005% ophthalmic solution PG324 Ophthalmic Solution 0.02%/0.005% PG324 Ophthalmic Solution 0.02%/0.005% Fixed combination of netarsudil 0.02%, latanoprost 0.005% ophthalmic solution
- Primary Outcome Measures
Name Time Method Intraocular Pressure (IOP) 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 Outcome Measures
Name Time Method Extent of Exposure 12 months Exposure to study medication in days for all treatment groups
Trial Locations
- Locations (1)
Aerie Pharmaceuticals
🇺🇸Bedminster, New Jersey, United States