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

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.