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Gregory Katz, Matthew Mcmenemy, Douglas Hubatsch, Tony Realini, Robert M Feldman; Demographic Subgroup Analysis in a Study Comparing the Additive Effect of Brinzolamide 1%/Brimonidine 0.2% in Patients with Open-Angle Glaucoma or Ocular Hypertension Treated with TRAVATAN Z® (NCT01937299). Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):5700.
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Brinzolamide 1%/Brimonidine 0.2% fixed combination (BBFC) has been shown to provide superior IOP-lowering efficacy when added to TRAVATAN Z® in comparison to TRAVATAN Z® monotherapy in a recently completed study.1 In this report, subgroups based on age, race and gender have been analyzed to detect differences in efficacy of BBFC+TRAVATAN Z® as compared to TRAVATAN Z®.<br /> 1Abstract submitted to American Glaucoma Society 2015.
NCT01937299 was a 2-arm, phase 4, randomized, double-masked study that evaluated the additive effect of BBFC in patients on TRAVATAN Z® monotherapy. The primary efficacy endpoint was mean diurnal IOP at 6 weeks, which was the measure used to compare the efficacy of BBFC+TRAVATAN Z® and TRAVATAN Z® monotherapy in demographic subgroups. Subgroups with n ≤ 10 have been excluded in this report. The comparison was made with descriptive statistics.
In the full intent-to-treat study population, the mean diurnal IOP at 6 weeks was 17.6 mmHg ±0.4 (Standard Error [SE]) in the BBFC+TRAVATAN Z® group (n=113) and 20.7 mmHg (±0.4 SE) in the TRAVATAN Z® group (n=116); P<0.0001. This improved IOP-lowering efficacy in the BBFC+TRAVATAN Z® group in comparison to the TRAVATAN Z® group was maintained irrespective of age, race and gender. The numerical comparisons of mean diurnal IOP at week 6 in the two treatment groups are shown in Table 1.
The efficacy of BBFC in lowering mean diurnal IOP, when added to TRAVATAN Z® monotherapy, was maintained at levels similar to the full cohort, in most subgroups, when analyzed by age, race and gender.
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