fixed combination brinzolamide 1%/timolol 0.5% versus brinzolamide 1% + timolol 0.5% in open-angle glaucoma or ocular hypertension

Conditions: Open-Angle Glaucoma; Ocular Hypertension

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.

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.

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.

Keywords: glaucoma open-angle glaucoma ocular hypertension oag oh