Fixed Combination Brinzolamide 1%/Timolol 0.5% Versus Brinzolamide 1% + Timolol 0.5% in Open-Angle Glaucoma or Ocular Hypertension
Condition: Open-Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension; Brinzolamide 1% ophthalmic suspension; Timolol 0.5% ophthalmic solution
Intervention MeSH terms: Timolol; Ophthalmic Solutions; Brinzolamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 328.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Glaucoma; Open-angle glaucoma; Ocular hypertension; OAG; OH

Summary:

      The purpose of this study was to compare the intraocular pressure (IOP)-lowering efficacy and
      safety of AZARGA™ (Brinzolamide 1%/Timolol 0.5% Ophthalmic Suspension), dosed twice daily
      versus AZOPT® (Brinzolamide 1% Ophthalmic Suspension) and Timolol 0.5% Ophthalmic Solution,
      each dosed twice daily, in Chinese patients with open-angle glaucoma or ocular hypertension
      who were insufficiently responsive to monotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with open angle glaucoma and/or ocular hypertension and not sufficiently
             responsive to monotherapy.

          -  Meet qualifying IOP criteria in at least 1 eye, including 21-35 mmHg at the
             Eligibility visit.

          -  Willing to sign an Informed Consent form.

          -  Contact lens wearer who is willing to remove lenses before instillation of study
             medication and wait a minimum of 15 minutes following drug instillation before
             re-inserting the lenses.

          -  Able to discontinue use of current IOP-lowering medications per the minimum washout
             period.

          -  Other protocol-specific inclusion criteria may apply.

        Exclusion Criteria:

          -  Women of childbearing potential if pregnant, test positive for pregnancy at
             Screening/Enrollment visit, breastfeeding, or not in agreement to use adequate birth
             control methods to prevent pregnancy throughout the study.

          -  Diagnosed with any form of glaucoma other than open-angle glaucoma and/or ocular
             hypertension.

          -  Diagnosed with severe central visual field loss in either eye.

          -  History of chronic, recurrent, or severe ocular infection, inflammatory eye disease in
             either eye.

          -  History of ocular trauma within the past 6 months in either eye.

          -  Current ocular infection or ocular inflammation within the past 3 months in either
             eye.

          -  Ocular laser surgery within the past 3 months.

          -  Intraocular surgery within the past 3 months.

          -  Best-corrected visual acuity score worse than 55 ETDRS letters read (equivalent to
             approximately 20/80 Snellen, 0.60 logMAR or 0.25 decimal).

          -  History of, or current clinically relevant or progressive retinal disease in either
             eye.

          -  History of, or current other severe ocular pathology (including severe dry eye) in
             either eye, that would preclude the administration of a topical carbonic anhydrase
             inhibitor (CAI) or beta-blocker.

          -  Any abnormality preventing reliable applanation tonometry.

          -  History of, or current condition or disease that would preclude the safe
             administration of a topical beta blocker or topical beta-adrenergic blocking agent.

          -  History of spontaneous or current hypoglycemia or uncontrolled diabetes.

          -  History of severe or serious hypersensitivity to CAIs, beta-blockers, or to any
             components of the study medication.

          -  Less than 30 days stable dosing regimen before the Screening Visit of any medications
             or substances administered by any route and used on a chronic basis that may have
             affected IOP.

          -  Recent use of high-dose salicylate therapy.

          -  Anticipated use of any additional topical or systemic ocular hypotensive medication
             during the study.

          -  Not safely able to discontinue all glucocorticoid medications administered by any
             route.

          -  Currently on therapy or have been on therapy with another investigational agent within
             30 days prior to the Screening Visit.

          -  History of, or current evidence of severe illness or any other conditions which would,
             in the opinion of the Investigator, make the subject unsuitable for the study.

          -  Other protocol-specific exclusion criteria may apply.