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Abstract #8754 Published in IGR 5-1
A 3-month comparison of efficacy and safety of brimonidine-Purite 0.15% and brimonidine 0.2% in patients with glaucoma or ocular hypertension
Mundorf T; Williams R; Whitcup S; Felix C; Batoosingh AJournal of Ocular Pharmacology and Therapeutics 2003; 19: 37-44
PURPOSE: To compare the efficacy and safety of brimonidine Purite 0.15% (ALPHAGANR P) BID with brimonidine 0.2% (ALPHAGANR) BID in patients with glaucoma or ocular hypertension. METHODS: A three-month, multicenter, randomized, double-masked trial. Eligible patients were taking brimonidine 0.2% BID for at least six weeks prior to study entry and their intraocular pressure (IOP) was ≤ 21 mmHg. 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 hours 0 and 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 ≤ 0.26 mmHg and the mean change from baseline IOP was ≤ 0.35 mmHg 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. CONCLUSIONS: 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%.
Dr. T. Mundorf, Presbyterian Medical Tower, 1718 E 4th Street, Charlotte, NC 28204, USA. tommundorf@aol.com
Classification:
11.3.3 Apraclonidine, brimonidine (Part of: 11 Medical treatment > 11.3 Adrenergic drugs)