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RD Williams, M Dirks, AL Batoosingh, C Felix, SM WhitcupBrimonidine--Purite Study Group; A 3-month Comparison of Brimonidine-Purite 0.15% BID With Brimonidine 0.2% BID in Patients Successfully Treated With Brimonidine 0.2% BID . Invest. Ophthalmol. Vis. Sci. 2002;43(13):284.
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Purpose: A new formulation of brimonidine preserved with Purite® instead of BAK has lead to improved ocular penetration. Pharmacokinetic studies have shown similar aqueous humor concentrations of brimonidine following dosing of brimonidine-Purite 0.15% (BrimP 0.15%) and brimonidine 0.2%. The purpose of this study was to compare the efficacy and safety of these two formulations. Methods: 3-month, randomized, double-masked, multi-center, parallel group study was performed. Glaucoma or ocular hypertensive patients who were already successfully treated (IOP at Hour 0 of less than or equal to 21 mm Hg) with brimonidine 0.2% BID for at least 6 weeks were randomized to receive either BrimP 0.15% (n=203) or brimonidine 0.2% BID (n = 204) with no wash-out period. Visits were scheduled at pre-study, day 0 (baseline), and weeks 2, 6, and 12. IOP, the primary efficacy variable, was measured at hour 0 and hour 2. The primary safety variable was incidence of adverse events. Results: There were no statistically significant differences between the two treatment groups in mean IOP at baseline or at any follow-up timepoint. The mean IOP at Hour 0 ranged from 19.3±2.4 to 19.5±2.8 for BrimP 0.15% BID and from 19.5±2.9 to 19.7±3.3 for brimonidine 0.2% BID with between-treatment differences of < 0.26 mm Hg. At hour 2 mean IOP ranged from 16.5±2.6 to 16.6±2.8 for BrimP 0.15% BID and from 16.4±3.0 to 16.7±2.9 for brimonidine 0.2% BID with between-treatment differences of < 0.13 mm Hg. Discontinuations due to adverse events were low in both groups: 2.0% for BrimP 0.15% and 2.5% for brimonidine 0.2%. Conclusion: BrimP 0.15% dosed BID has the same IOP lowering efficacy as brimonidine 0.2% BID.
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