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Clinical Trials |

Three-Month Randomized Trial of Fixed-Combination Brinzolamide, 1%, and Brimonidine, 0.2%

Gregory Katz, MD; Harvey DuBiner, MD; John Samples, MD; Steven Vold, MD; Kenneth Sall, MD
JAMA Ophthalmol. 2013;131(6):724-730. doi:10.1001/jamaophthalmol.2013.188.
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Importance This study evaluates the contribution of the individual components of an investigational non–β-antagonist fixed combination of brinzolamide, 1%, and brimonidine, 0.2%. This study and its sister study provide the first randomized data showing the intraocular pressure (IOP)-lowering activity and the toxicity profile of this novel topical antihypertensive fixed combination.

Objective To compare IOP-lowering efficacy of fixed-combination brinzolamide, 1%, and brimonidine, 0.2%, with that of its components in patients with open-angle glaucoma or ocular hypertension.

Design In this phase 3, double-masked, parallel-group, multicenter study, eligible patients were randomized 1:1:1 to treatment with fixed-combination brinzolamide, 1%, and brimonidine, 0.2%; brinzolamide, 1%; or brimonidine, 0.2%, 3 times daily for 3 months.

Setting Sixty-six academic and private practice study sites throughout the United States.

Participants A total of 660 adults with a clinical diagnosis of open-angle glaucoma or ocular hypertension from a referred sample were enrolled. Thirty-four patients discontinued participation due to treatment-related nonserious adverse events.

Intervention Topical administration of study medication (fixed-combination brinzolamide, 1%, and brimonidine, 0.2%; brinzolamide, 1%; or brimonidine, 0.2%) 1 drop 3 times daily for 3 months.

Main Outcomes and Measures Mean IOP at the 3-month visit at all time points (8 AM, 10 AM, 3 PM, and 5 PM).

Results A total of 660 patients were enrolled. Baseline mean IOP values were similar among treatment groups at all 4 time points. At 3 months, the mean IOP of the brinzolamide-brimonidine group (16.3-19.8 mm Hg) was significantly lower than that of either the brinzolamide group (19.3-20.9 mm Hg; P ≤ .002) or the brimonidine group (17.9-22.5 mm Hg; P < .001) across all time points. One of 10 serious adverse events (chest pain, brinzolamide group) was judged as treatment related. A total of 129 patients experienced at least 1 treatment-related adverse effect (brinzolamide-brimonidine, 22.9%; brinzolamide, 18.6%; and brimonidine, 17.3%; P = .31), most of which were ocular.

Conclusions and Relevance This registrational study provides evidence that the fixed combination of brinzolamide, 1%, and brimonidine, 0.2%, can safely and effectively lower IOP in patients with open-angle glaucoma or ocular hypertension, showing significantly superior IOP-lowering activity compared with either brinzolamide or brimonidine monotherapy while providing a safety profile consistent with that of its individual components.

Trial Registration clinicaltrials.gov Identifier: NCT01297517

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Figures

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Figure 1. Participant flowchart. Patients receiving an incorrect study drug were included in the safety population of the actual drug received and in the intent-to-treat (ITT) population of the intended drug. BBFC indicates brinzolamide, 1%, and brimonidine, 0.2%, in a fixed combination; IOP, intraocular pressure.

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Figure 2. Percentage reduction in mean intraocular pressure (IOP) from the baseline visit to the 3-month visit across treatment groups and time points. BBFC indicates a fixed combination of brinzolamide, 1%, and brimonidine, 0.2%.

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