safety and efficacy of adding azarga® adjunctive to prostaglandin therapy

Conditions: Glaucoma; Ocular Hypertension

Summary: the purpose of this study was to evaluate the safety and efficacy of adding azarga® as a single agent to prostaglandin monotherapy in patients with either ocular hypertension or primary open-angle glaucoma.

this study consisted of 3 study visits (screening/baseline, week 4, and week 12). eligible patients self-administered the study medication (azarga® eye drops), adjunct to their current prostaglandin monotherapy for 3 months.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of ocular hypertension, primary open angle (including pigment dispersion) glaucoma in both eyes. * iop considered to be safe, in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period. * treated with, and in the investigator's judgment demonstrated an inadequate response to, prostaglandin monotherapy for a minimum of 4 weeks at visit 1. last dose of prostaglandin instilled correctly to put patient within the dosing cycle at visit 1. * at visit 1, have an iop of ≥ 20 mmhg in at least one eye and ≤ 35 mmhg in both eyes treated with prostaglandin monotherapy. * best corrected visual acuity of 1.0 logmar or better in each eye. * in any eye not qualifying as a study eye, iop should be able to be controlled on no pharmacologic therapy or on prostaglandin monotherapy alone. * willing to sign an informed consent form. * able to follow instructions and willing and able to attend required study visits. * other protocol-defined inclusion criteria may apply. 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. * other protocol-defined exclusion criteria may apply.

Keywords: azarga® open angle glaucoma prostaglandin therapy