Study to Compare the Safety and Efficacy of ALZ-1101 to Latanoprost in Patients With Intraocular Pressure Inadequately Controlled by Latanoprost

Exclusion Criteria

• •1. A mean deviation of \< -20 dB on visual field (VF) assessment.
• •2. Presence of a scotoma within 5°of fixation on VF.
• •3. Aphakia.
• •4. Use of any antiglaucoma medication in addition to latanoprost QD within 2 weeks prior to Visit 1 or during the study period.
• •5. Use of any topical ophthalmic steroid or nonsteroidal anti-inflammatory drug (NSAID) within 2 weeks prior to Visit 1 or during the study period.
• •6. Use of systemic carbonic anhydrase inhibitor within 2 weeks prior to Visit 1 or during the study period.
• •7. Ocular surgery or ocular laser treatment of any kind within 3 months prior to Visit 1 or during the study period.
• •8. Any history of glaucoma surgery (laser or non-laser).
• •9. 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, is acceptable.
• •10. History of ocular trauma or ocular infection within 3 months of Visit 1.
• •11. History of herpes simplex keratitis.
• •12. Current proliferative diabetic retinopathy or age-related macular degeneration, unless deemed not clinically significant by the Investigator.
• •13. 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 applications per day).
• •14. Contact lens wear within one week prior to Visit 1 or during the study period (contact lens wear in an untreated fellow eye is allowed).
• •15. Angle closure or occludable angles (Shaffer gonioscopic grade of \< 3).
• •16. Cataract that compromises visualization of the fundus.
• •17. Cup-to-disc (C/D) ratio of \> 0.8.
• •18. Any secondary glaucoma or OH (eg, congenital glaucoma, closed-angle glaucoma, uveitic glaucoma, or pseudoexfoliation syndrome).
• •19. Pregnancy or lactation.
• •20. Uncontrolled asthma (defined as asthma that does not respond to the maximum guideline directed therapy).
• •21. Allergy to prostaglandin analogues or carbonic anhydrase inhibitors.
• •22. Allergy to benzalkonium chloride.
• •23. History of moderate or severe renal or hepatic impairment.
• •24. Participation in any study of an investigational product within 30 days prior to Visit 1 or at any time during the study period.