PURPOSE: To compare the efficacy and safety of brimonidine Purite 0.15% (ALPHAGAN P) BID with brimonidine 0.2% (ALPHAGAN) BID in patients with glaucoma or ocular hypertension. METHODS: 3-month, multicenter, randomized, double-masked trial. Eligible patients were taking brimonidine 0.2% BID for at least 6 weeks prior to study entry and their intraocular pressure (IOP) was < or = 21 mm Hg. Patients were randomly assigned to receive either brimonidine Purite 0.15% BID (n = 203) or brimonidine 0.2% BID (n = 204). Scheduled visits were prestudy, baseline, and weeks 2, 6 and 12. IOP was measured at hour 0 and hour 2 to evaluate efficacy. Safety was measured by monitoring adverse events. Patient satisfaction and comfort were also evaluated at all visits. RESULTS: There was no statistically significant difference between the brimonidine 0.2% and brimonidine Purite 0.15% groups with respect to mean IOP at baseline. The IOP-lowering efficacy of brimonidine Purite 0.15% was equivalent to that of brimonidine 0.2% and both study treatments maintained IOP-lowering effects of brimonidine 0.2%. There were no significant between-group differences in mean IOP. The differences in the mean IOPs were < or = 0.26 mm Hg and the mean change from baseline IOP was < or = 0.35 mm Hg at all follow-up time points. There were no statistically significant differences between the two groups in the overall incidence of adverse events. The most commonly reported treatment-related adverse events were conjunctival hyperemia and allergic conjunctivitis: both were mild in severity. CONCLUSION:Brimonidine Purite 0.15% dosed BID provides equal IOP-lowering efficacy to brimonidine 0.2% BID. Patients previously controlled on brimonidine 0.2% can be successfully switched to brimonidine Purite 0.15%.
RCT Entities:
PURPOSE: To compare the efficacy and safety of brimonidine Purite 0.15% (ALPHAGAN P) BID with brimonidine 0.2% (ALPHAGAN) BID in patients with glaucoma or ocular hypertension. METHODS: 3-month, multicenter, randomized, double-masked trial. Eligible patients were taking brimonidine 0.2% BID for at least 6 weeks prior to study entry and their intraocular pressure (IOP) was < or = 21 mm Hg. Patients were randomly assigned to receive either brimonidine Purite 0.15% BID (n = 203) or brimonidine 0.2% BID (n = 204). Scheduled visits were prestudy, baseline, and weeks 2, 6 and 12. IOP was measured at hour 0 and hour 2 to evaluate efficacy. Safety was measured by monitoring adverse events. Patient satisfaction and comfort were also evaluated at all visits. RESULTS: There was no statistically significant difference between the brimonidine 0.2% and brimonidine Purite 0.15% groups with respect to mean IOP at baseline. The IOP-lowering efficacy of brimonidine Purite 0.15% was equivalent to that of brimonidine 0.2% and both study treatments maintained IOP-lowering effects of brimonidine 0.2%. There were no significant between-group differences in mean IOP. The differences in the mean IOPs were < or = 0.26 mm Hg and the mean change from baseline IOP was < or = 0.35 mm Hg at all follow-up time points. There were no statistically significant differences between the two groups in the overall incidence of adverse events. The most commonly reported treatment-related adverse events were conjunctival hyperemia and allergic conjunctivitis: both were mild in severity. CONCLUSION:Brimonidine Purite 0.15% dosed BID provides equal IOP-lowering efficacy to brimonidine 0.2% BID. Patients previously controlled on brimonidine 0.2% can be successfully switched to brimonidine Purite 0.15%.