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Clinical Trial
. 2013 Apr;29(3):290-7.
doi: 10.1089/jop.2012.0235. Epub 2013 Feb 20.

Phase 3 randomized 3-month trial with an ongoing 3-month safety extension of fixed-combination brinzolamide 1%/brimonidine 0.2%

Quang H Nguyen  1 , Matthew G McMenemy, Tony Realini, Jess T Whitson, Stephen M Goode
Affiliations
Clinical Trial

Phase 3 randomized 3-month trial with an ongoing 3-month safety extension of fixed-combination brinzolamide 1%/brimonidine 0.2%

Quang H Nguyen et al. J Ocul Pharmacol Ther. 2013 Apr.

Abstract

Purpose: This study compared the intraocular pressure (IOP)-lowering efficacy of fixed-combination brinzolamide 1%/brimonidine 0.2% (BBFC) with that of its component medications, brinzolamide and brimonidine, in patients with open-angle glaucoma or ocular hypertension.

Patients and methods: In this phase 3, multicenter, double-masked, parallel-group, 3-month study with a 3-month safety extension, eligible patients were randomized 1:1:1 to treatment with BBFC, brinzolamide, or brimonidine thrice daily after a washout period, during which any IOP-lowering medications were discontinued. The primary objectives of this study were to determine whether the IOP-lowering efficacy of BBFC was superior to that of brinzolamide alone and, separately, of brimonidine alone. IOP was assessed at 8:00 AM, 10:00 AM, 3:00 PM, and 5:00 PM at 2 weeks, 6 weeks, and 3 months after study drug initiation.

Results: A total of 690 patients were enrolled in the study, and 615 completed the 3-month visit. Baseline mean IOP levels were similar among the 3 treatment groups at each of the 4 time points assessed. At the 3-month primary endpoint, mean IOP of the BBFC group was significantly lower than that of either the brinzolamide group or the brimonidine group (P≤0.005) across all time points. At the 2- and 6-week supportive endpoints, mean IOP of the BBFC group was significantly lower at all time points than the mean IOP of either the brinzolamide group (P≤0.01) or the brimonidine group (P<0.0001). A total of 143 patients experienced at least 1 treatment-related adverse event (AE; BBFC group, n=58, 26.2%; brinzolamide group, n=44, 18.8%; brimonidine group, n=41, 17.4%), the majority of which were ocular AEs.

Conclusions: This study demonstrated that BBFC has significantly superior IOP-lowering activity compared with either brinzolamide 1% or brimonidine 0.2% in patients with open-angle glaucoma or ocular hypertension while providing a safety profile which is consistent with that of the individual components.

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Figures

FIG. 1.
FIG. 1.
Percent reduction in mean intraocular pressure (IOP) from the baseline visit to the 3-month visit across treatment groups and time points.
FIG. 2.
FIG. 2.
Distribution of systolic and diastolic blood pressures at 10:00 AM: baseline visit versus exit visit.
See this image and copyright information in PMC

References

    1. The Advanced Glaucoma Intervention Study (AGIS): 7. The relationship between control of intraocular pressure and visual field deterioration. The AGIS Investigators. Am. J. Ophthalmol. 2000;130:429–440. - PubMed
    1. Leske M.C. Heijl A. Hussein M., et al. Factors for glaucoma progression and the effect of treatment: the early manifest glaucoma trial. Arch. Ophthalmol. 2003;121:48–56. - PubMed
    1. Musch D.C. Gillespie B.W. Niziol L.M. Lichter P.R. Varma R. Intraocular pressure control and long-term visual field loss in the Collaborative Initial Glaucoma Treatment Study. Ophthalmology. 2011;118:1766–1773. - PMC - PubMed
    1. Kass M.A. Heuer D.K. Higginbotham E.J., et al. The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch. Ophthalmol. 2002;120:701–713. - PubMed
    1. Kass M.A. Gordon M.O. Gao F., et al. Delaying treatment of ocular hypertension: the ocular hypertension treatment study. Arch. Ophthalmol. 2010;128:276–287. - PMC - PubMed

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