Study Assessing Safety and Efficacy of PG324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure

Aerie Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Open Angle Glaucoma; Ocular Hypertension

Treatments: Drug: PG324 Ophthalmic Solution 0.01%; Drug: PG324 Ophthalmic Solution 0.02%; Drug: Latanoprost Ophthalmic Solution 0.005%; Drug: Netarsudil (AR-13324) Ophthalmic Solution 0.02%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02057575

PG324-CS201

Details and patient eligibility

About

To evaluate the ocular hypotensive efficacy of PG324 ophthalmic solution relative to its individual components in patients with open angle glaucoma or ocular hypertension.

Enrollment: 298 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• Any abnormality preventing reliable applanation tonometry of either eye

Systemic:

• Clinically significant abnormalities (as determined by the investigator) in laboratory tests at screening.
• Clinically significant systemic disease
• Participation in any investigational study within 30 days prior to screening
• Changes in systemic medication
• Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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298 participants in 4 patient groups

PG324 Ophthalmic Solution 0.01%

Experimental group

Description:

Netarsudil 0.01%, Latanoprost 0.005% fixed combination ophthalmic solution

Treatment:

Drug: PG324 Ophthalmic Solution 0.01%

PG324 Ophthalmic Solution 0.02%

Experimental group

Description:

Netarsudil 0.02%, Latanoprost 0.005% fixed combination ophthalmic solution

Treatment:

Drug: PG324 Ophthalmic Solution 0.02%

Netarsudil (AR-13324) Ophthalmic Solution 0.02%

Active Comparator group

Description:

Netarsudil 0.02% ophthalmic solution

Treatment:

Drug: Netarsudil (AR-13324) Ophthalmic Solution 0.02%

Latanoprost Ophthalmic Solution 0.005%

Active Comparator group

Description:

Latanoprost 0.005% ophthalmic solution

Treatment:

Drug: Latanoprost Ophthalmic Solution 0.005%