efficacy and safety of brinzolamide/brimonidine fixed combination bid compared to brinzolamide bid plus brimonidine bid in subjects with open-angle glaucoma (oag) or ocular hypertension (oht)

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Summary: the purpose of this study is to compare the fixed combination (bid) \[brinzolamide 10 mg/ml / brimonidine 2 mg/ml eyes drops, suspension\] to the unfixed combination (bid) \[brinzolamide 10 mg/ml eye drops, suspension plus brimonidine 2 mg/ml eyes drops, solution\] with respect to intraocular pressure (iop)-lowering efficacy.

this study is divided into 2 phases conducted in sequence for a total of 6 visits: phase i (screening/eligibility) which includes a screening visit, followed by 2 eligibility visits (e1 and e2) and phase ii (treatment/follow-up) which includes 3 visits at week 2, week 6, and month 3. following washout of any iop-lowering medication, subjects who meet all inclusion/exclusion criteria at both eligibility visits and had iop measurements within the specified range during this period will be randomized to phase ii.

Eligibility criteria:
inclusion criteria: * diagnosis of open-angle glaucoma or ocular hypertension insufficiently controlled on monotherapy or currently on multiple iop-lowering medications; * mean iop measurements within guidelines specified in the protocol. must not be \> 36 mmhg at any time point; * able to understand and sign an informed consent form; * other protocol-specified inclusion criteria may apply. exclusion criteria: * women of childbearing potential who are pregnant, test positive for pregnancy, intend to become pregnant during the study period, breast-feeding, or not in agreement to use adequate birth control methods throughout the study; * severe central visual field loss in either eye; * unable to safely discontinue all iop-lowering ocular medication(s) for a minimum of 5 (± 1) to 28 (± 1) days prior to e1 visit; * chronic, recurrent or severe inflammatory eye disease; * ocular trauma within the past 6 months; * ocular infection or ocular inflammation within the past 3 months; * clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment; * best-corrected visual acuity (bcva) score worse than 55 etdrs letters (equivalent to approximately 0.60 logmar, 20/80 snellen, or 0.25 decimal); * other ocular pathology (including severe dry eye) that may preclude the administration of α-adrenergic agonist and/or topical carbonic anhydrase inhibitor (cai); * intraocular surgery within the past 6 months; * ocular laser surgery within the past 3 months; * any abnormality preventing reliable applanation tonometry; * any conditions including severe illness which would make the subject, in the opinion of the investigator, unsuitable for the study; * history of active, severe, unstable or uncontrolled cardiovascular, cerebrovascular, hepatic, or renal disease that would preclude safe administration of a topical α-adrenergic agonist or cai; * recent (within 4 weeks of the e1 visit) use of high-dose (\> 1 g daily) salicylate therapy; * current or anticipated treatment with any psychotropic drugs that augment adrenergic response (eg, desipramine, amitriptyline); * concurrent use of monoamine oxidase inhibitors (maoi); * concurrent use of glucocorticoids administered by any route; * therapy with another investigational agent within 30 days prior to the screening visit; * hypersensitivity to α-adrenergic agonist drugs, topical or oral cais, sulfonamide derivatives, or to any component of the study medications; * less than 30 days stable dosing regimen before the screening visit of any medications (excluding iop-lowering treatments) or substances administered by any route and used on a chronic basis that may affect iop, including but not limited to β-adrenergic blocking agents; * use of any additional topical or systemic ocular hypotensive medication during the study; * other protocol-specified exclusion criteria may apply.

Keywords: oag oht