Fixed Combination Brinzolamide 1%/Timolol 0.5% Versus Brinzolamide 1% + Timolol 0.5% in Open-Angle Glaucoma or Ocular Hypertension

Comparison of Efficacy and Safety of Brinzolamide/Timolol Fixed Combination (AZARGA™) vs Brinzolamide (AZOPT®) and Timolol in Chinese Subjects With Open-Angle Glaucoma or Ocular Hypertension

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.

The study consisted of 2 sequential phases. Phase I was the Screening/Eligibility Phase, with a Screening Visit followed by an Eligibility Visit. Phase II was the treatment phase and included Week 1, Week 2, Week 4, and Week 8 visits. Eligible subjects were randomized in a 1:1 ratio to receive Brinzolamide 1%/Timolol 0.5% or Brinzolamide 1% plus Timolol 0.5% two times a day for 8 weeks.

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.