Double-masked Study of PG324 Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension

Inclusion criteria

• 18 years of age or older (19 years of age or older in Canada)
• Diagnosis of open angle glaucoma (OAG) or ocular hypertension(OHT) in both eyes
• Unmedicated intraocular pressure >20mmHg and <36mmHg in both eyes at 2 qualification visits
• Best corrected visual acuity (BCVA) equivalent to 20/200 Snellen or better
• Able to give informed consent and follow study instructions

Exclusion criteria

Ophthalmic:

• Clinically significant ocular disease
• Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure or narrow angles
• Unmedicated intraocular pressure ≥36mmHg in either eye or use of more than 2 ocular hypotensive medications within 30 days of screening
• Known hypersensitivity to any component of the formulation or latanoprost
• Previous glaucoma surgery or refractive surgery
• Ocular trauma within 6 months prior to screening
• Any ocular surgery or non-refractive laser treatment within 3 months prior to screening
• Recent or current ocular infection or inflammation in either eye
• Use of ocular medication in either eye of any kind within 30 days of screening and throughout of the study
• Mean central corneal thickness >620µm at screening in either eye
• Any abnormality preventing reliable applanation tonometry of either eye

Systemic:

• Clinically significant abnormalities in lab tests at screening
• Clinically significant systemic disease
• Participation in any investigational study within 60 days prior to screening
• Systemic medication that could have had a substantial effect on IOP within 30 days prior to screening, or anticipated to be used during the study
• Women of childbearing potential who were pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control