Safety and Efficacy of Adding AZARGA® Adjunctive to Prostaglandin Therapy

Launched by ALCON RESEARCH · Dec 17, 2010

Keywords

ClinConnect Summary

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.

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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.