Safety and Efficacy of Adding AZARGA® Adjunctive to Prostaglandin Therapy

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Bimatoprost; Brinzolamide; Latanoprost; Timolol; Travoprost

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.