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

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aerie Pharmaceuticals
• Treatments: Latanoprost; Ophthalmic Solutions; Pharmaceutical Solutions

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

• 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.