Safety and Efficacy of T-2345 Compared to Xalatan in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

Inclusion Criteria

• Age 18 years or older.
• POAG or OH with IOP treated and adequately controlled (IOP ≤ 18 mm Hg) with latanoprost 0.005% ophthalmic solution monotherapy for at least 4 weeks prior to Screening.
• Each eye being treated with latanoprost 0.005% ophthalmic solution monotherapy must have mean IOP ≤ 18 mm Hg at Screening and mean IOP ≤ 28 mm Hg at Baseline; measurements will be taken at each visit at 8 AM, 10 AM, and 4 PM (each ± 30 minutes) with AM measurements of IOP at least 2 hours apart. If only one eye qualifies but both eyes have glaucoma and the fellow eye will require antiglaucoma medications, the subject does not qualify for the trial.
• Stable visual field (VF), defined as no sign of VF degradation between two consecutive 30-2 or two consecutive 24-2 VF examinations. For subjects with no VF defect (eg, those with OH), a single, normal VF examination performed ˂ 6 months prior to the screening visit is allowed to determine eligibility. For patients who have an abnormal VF examination, the following criteria apply:
• Two VF (most recent VF and past VF) examinations performed at least ≥ 6 months and ≤ 18 months apart must be compared;
• The most recent VF examination should be performed 2 weeks prior to Screening. Inhaled and intranasal steroids are acceptable.
• Use of topical nonsteroidal anti-inflammatory drug (NSAID) within 2 weeks prior to Baseline.
• Use of any ophthalmic medications during the study period (nonpreserved artificial tears are allowed).
• Ocular surgery or laser treatment of any kind in the study eye within 3 months prior to Baseline.
• History of ocular allergy/inflammation and/or severe blepharitis and/or uveitis. Seasonal allergic conjunctivitis is acceptable (avoid enrollment of subjects who may experience seasonal flare-up during the study period). Mild blepharitis/blepharoconjunctivitis, typically associated with prostaglandin usage, on the lid is acceptable.
• History of ocular trauma or ocular infection within 3 months of Screening.
• History of herpes simplex keratitis.
• Current proliferative diabetic retinopathy or age-related macular degeneration, unless deemed not clinically significant by the Investigator.
• Severe dry eye (eg, clinically relevant superficial punctate keratitis, epithelial erosions of the cornea, and/or use of dry eye medication [including artificial tears] with a frequency exceeding 8 instillations per day).
• Contact lens wear during the study period. Contact lens wear in an untreated fellow eye is allowed.
• Any secondary glaucoma or OH (eg, congenital glaucoma, closed-angle glaucoma, uveitic glaucoma, or pseudoexfoliation syndrome).
• Any severe glaucoma defined by cupping (cup-to-disc ratio ≥ 0.8).
• Any non-laser glaucoma surgery.
• Any abnormality preventing accurate assessment (eg, resulting in unreliable applanation tonometry or VF examination).

General:

• Pregnancy or lactation.
• Uncontrolled asthma (defined as asthma that does not respond to the maximum guideline-directed therapy).
• Allergy to benzalkonium chloride.
• History of moderate or severe renal or hepatic impairment.
• Participation in any study of an investigational product within 30 days prior to Screening or at any time during the study period.