Safety and Efficacy of Adding AZARGA® Adjunctive to Prostaglandin Therapy
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension
Intervention: Brinzolamide 1% / timolol 0.5% Fixed Combination; Habitual prostaglandin monotherapy
Intervention description: Topical ocular therapy used daily as prescribed
Intervention MeSH terms: Timolol; Bimatoprost; Travoprost; Latanoprost; Brinzolamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: AZARGA®; Open angle glaucoma; Prostaglandin Therapy

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.
    

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.