Safety and tolerability of brimonidine purite 0.1% and brimonidine purite 0.15%: a meta-analysis of two phase 3 studies

ABSTRACT Objective: To compare the safety and tolerability of two formulations of brimonidine ophthalmic solution, brimonidine Purite* (P) 0.1% and brimonidine P 0.15%, for reducing intraocular pressure in patients with glaucoma or ocular hypertension (OHT). *Purite is a registered trademark of Allergan, Inc., Irvine, CA, USA Study design and methods: Meta-analysis of safety and tolerability results from two previously reported prospective, randomized, 12-month, double-masked, multicenter, parallel-group clinical studies with similar entry criteria and protocols. In study 1 (two clinical trials), after washout of previous medications, patients with glaucoma or OHT were randomized to thrice-daily treatment with brimonidine P 0.15% (n = 381), brimonidine P 0.2% (n = 383), or brimonidine 0.2% (n = 383). In study 2 (one clinical trial), the treatment arms were thrice-daily brimonidine P 0.1% (n = 215) and brimonidine 0.2% (n = 218). Main outcome measure: Treatment-related adverse events (AEs) and discontinuations due to AEs. Results: Treatment-related AEs were significantly reduced with brimonidine P 0.15% compared with brimonidine 0.2% in study 1 (p