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 or ocular hypertension
• Corrected visual acuity in each eye equivalent to 20/200
• Able and willing to give signed informed consent and follow study instructions.
• Additional protocol-specific criteria may apply

Exclusion Criteria:

• Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles.
• Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), 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.
• Clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications for one month is not judged safe
• Clinically significant abnormalities (as determined by the investigator) in laboratory tests at screening.
• Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.
• Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. An adult woman is considered to be of childbearing potential unless she is one year post-menopausal or three months post-surgical sterilization. All females of childbearing potential must have a negative urine pregnancy test result at the screening examination and must not intend to become pregnant during the study.
• Additional protocol-specific criteria may apply