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
Overview
- Phase
- Phase 2
- Intervention
- PG324 Ophthalmic Solution 0.01%
- Conditions
- Open Angle Glaucoma
- Sponsor
- Aerie Pharmaceuticals
- Enrollment
- 298
- Locations
- 23
- Primary Endpoint
- Intraocular Pressure (IOP)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
To evaluate the ocular hypotensive efficacy of PG324 ophthalmic solution relative to its individual components in patients with open angle glaucoma or ocular hypertension.
Investigators
Eligibility Criteria
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
Arms & Interventions
PG324 Ophthalmic Solution 0.01%
Netarsudil 0.01%, Latanoprost 0.005% fixed combination ophthalmic solution
Intervention: PG324 Ophthalmic Solution 0.01%
PG324 Ophthalmic Solution 0.02%
Netarsudil 0.02%, Latanoprost 0.005% fixed combination ophthalmic solution
Intervention: PG324 Ophthalmic Solution 0.02%
Netarsudil (AR-13324) Ophthalmic Solution 0.02%
Netarsudil 0.02% ophthalmic solution
Intervention: Netarsudil (AR-13324) Ophthalmic Solution 0.02%
Latanoprost Ophthalmic Solution 0.005%
Latanoprost 0.005% ophthalmic solution
Intervention: Latanoprost Ophthalmic Solution 0.005%
Outcomes
Primary Outcomes
Intraocular Pressure (IOP)
Time Frame: Study treatment was administered for 28 days, and outcome measures collected on Day 29
The primary efficacy endpoint was the mean diurnal IOP across subjects within treatment group at Day 29.