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Jonathan S Myers, Harvey Dubiner, Donald L Budenz, Douglas Hubatsch, Robert Fechtner; Effect of Prostaglandin Analog Type in a Study Comparing the Additive Effect of Brinzolamide 1%/Brimonidine 0.2% in Patients with Open-Angle Glaucoma or Ocular Hypertension Treated with a Prostaglandin Analog. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):5808.
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Brinzolamide 1%/brimonidine 0.2% fixed combination (BBFC) has been evaluated as an adjunct to prostaglandin analog (PGA) therapy in a 6-week study, and has proven efficacious in producing further IOP lowering in this recently completed study.1 Here, we report results of an analysis done to determine differences in IOP-lowering efficacy of BBFC when added to TRAVATAN Z®, XALATAN® or LUMIGAN® monotherapy.<br /> 1 Accepted for presentation at the 2015 Annual Meeting of the American Glaucoma Society
NCT01937312 is a 2-arm, phase 4, randomized, double-masked study, which evaluated the additive effect of BBFC in patients on PGA monotherapy (TRAVATAN Z®, XALATAN® and LUMIGAN®). The primary efficacy endpoint was mean diurnal IOP at 6 weeks; which was the measure used to compare the effect of the individual PGAs on IOP-lowering in combination with BBFC. Descriptive statistics were provided.
In the full ITT cohort, the mean diurnal IOP at 6 weeks was 17.1 mmHg (±0.4 SE) in the BBFC+PGA group (n=88) and 20.5 mmHg (±0.4 SE) in the Vehicle + PGA group (n=94). When analyzed by PGA-monotherapy subgroups, the mean diurnal IOP in the BBFC+PGA and Vehicle + PGA groups respectively was 17.45 mmHg (±0.53 SE; n=23) vs 20.40 mmHg (±0.69 SE; n=23) for TRAVATAN Z®; 16.78 mmHg (±0.50 SE; n=31) vs 19.99 mmHg (±0.69 SE; n=37) for XALATAN® and 16.9 mmHg (±0.62 SE; n=29) vs 20.78 mmHg (±0.71 SE; n=32) for LUMIGAN® (Figure 1).
The additive effect of BBFC in lowering mean diurnal IOP, when added to PGA monotherapy was maintained at levels similar to the full cohort, when analyzed by type of PGA (TRAVATAN Z®, XALATAN® or LUMIGAN®) used.
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