Efficacy and Tolerability of AZARGA® as Replacement Therapy in Patients on COMBIGAN® Therapy in Canada
Condition: Glaucoma; Ocular Hypertension; Open-angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Brinzolamide 1% / timolol 0.5% maleate fixed combination
Intervention MeSH terms: Timolol; Brinzolamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Glaucoma; Ocular hypertension; Intraocular pressure (IOP); Open angle glaucoma; Pigment dispersion glaucoma; Pigmentary

Summary:

      The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA®
      from prior brimonidine 0.2%/timolol 0.5% fixed combination (COMBIGAN®) therapy in patients
      with open-angle glaucoma or ocular hypertension and uncontrolled intraocular pressure (IOP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing to sign an Informed Consent form.

          -  Clinical diagnosis of ocular hypertension, exfoliative open-angle or pigment
             dispersion glaucoma in at least one eye (study eye).

          -  Be on a stable IOP lowering regimen within 30 days of Screening Visit.

          -  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.

          -  Willing to discontinue the use of COMBIGAN® prior to receiving the study drug at Visit
             1.

          -  IOP of between 19 and 35 mmHg in at least one eye (which would be the study eye) while
             on brimonidine/timolol fixed combination therapy.

          -  Best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 logMAR) or better in each
             eye.

          -  Willing to follow instructions and able to attend required study visits.

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Known history of hypersensitivity to any component of the preparations used in this
             study.

          -  Presence of primary or secondary glaucoma not listed in inclusion criterion #2.

          -  History of ocular herpes simplex.

          -  Abnormality preventing reliable applanation tonometry.

          -  Corneal dystrophies.

          -  Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either
             eye. Blepharitis or non-clinically significant conjunctival injection is allowed.

          -  Intraocular conventional surgery or laser surgery in study eye(s) less than 3 months
             prior to the Screening Visit.

          -  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.

          -  Women of childbearing potential not using reliable means of birth control for at least
             1 month prior to the Screening/Baseline Visit.

          -  Pregnant or lactating.

          -  Other protocol-defined exclusion criteria may apply.