Safety and Efficacy of Adding AZARGA® Adjunctive to Prostaglandin Therapy

Exclusion Criteria

• •Known medical history of allergy, hypersensitivity or poor tolerance to any component of AZARGA® that is deemed clinically significant in the opinion of the investigator.
• •A history of, or at risk for uveitis or cystoid macular edema (CME).
• •History of ocular herpes simplex.
• •Corneal dystrophies in either eye.
• •Concurrent infectious/non infectious conjunctivitis, keratitis or uveitis in either eye (excluding Blepharitis or non-clinically significant conjunctival hyperemia).
• •Intraocular conventional surgery or laser surgery in study eye(s) less than 3 months prior to Visit 1.
• •Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
• •Progressive retinal or optic nerve disease from any cause apart from glaucoma.
• •Use of systemic medications known to affect IOP (e.g. oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for 7 days prior to Visit 1 or an anticipated change in the dosage during the course of the study.
• •Use of corticosteroids (oral, topical ocular or nasal) within 30 days of Visit 1 and during the course of the study.
• •Bronchial asthma or a history of bronchial asthma, bronchial hyper reactivity, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
• •History of severe allergic rhinitis.
• •A condition, which in the opinion of the principal investigator, would interfere with optimal participation in the study, or which would present a special risk to the subject.
• •Use of any systemic carbonic anhydrase inhibitors (CAI) (e.g. methazolamide \[Neptazane\], acetazolamide \[Diamox\]).
• •Severely impared renal function.
• •History of an allergy to sulphonamides.
• •Bronchial asthma or a history of bronchial asthma, bronchial hyper reactivity, severe allergic rhinitis or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
• •Pregnant, lactating, or of childbearing potential and not using a reliable method of birth control.
• •Any clinically significant, serious, or severe medical condition.
• •Participation in any other investigational study within 30 days prior to the screening/baseline visit.