Brimonidine-purite 0.1% versus brimonidine-purite 0.15% twice daily in glaucoma or ocular hypertension: a 12-month randomized trial^*

ABSTRACT

Objective: To compare the safety and intraocular pressure (IOP)-lowering effects of brimonidine-purite^‡ 0.1% with the marketed formulation of brimonidine-purite 0.15% (Alphagan P^§ 0.15%) when used twice daily (BID) by patients with glaucoma or ocular hypertension previously treated with brimonidine-purite 0.15% for at least 6 weeks.

Methods: In a 12-month, randomized, double-masked, multicenter, parallel group, non-inferiority study, patients with glaucoma or ocular hypertension who were treated with brimonidine-purite 0.15% BID were randomly assigned to continue brimonidine-purite 0.15% (n = 102) or to administer brimonidine-purite 0.1% (n = 105) BID for 12 months. IOP was measured at approximately 8 a.m. (hour 0) and 10 a.m. (hour 2).

Main outcome measures: Mean change from baseline IOP and adverse events.

Results: Demographics and baseline characteristics were similar between treatment groups. Treated-baseline mean IOPs at both timepoints were similar between groups (p ≥ 0.606). Brimonidine-purite 0.1% provided IOP-lowering that was non-inferior to brimonidine-purite 0.15% at each of the 12 follow-up timepoints, and there were no statistically significant between-group differences at any timepoint. The most commonly reported adverse event was conjunctival hyperemia (13.5% for brimonidine-purite 0.1%; 10.8% for brimonidine-purite 0.15%). No significant differences in the incidence of adverse events were noted between the two formulations.

Conclusions: Brimonidine-purite 0.1% BID is as effective as brimonidine-purite 0.15% BID in lowering IOP in patients with glaucoma or ocular hypertension who were previously treated with brimonidine-purite 0.15%, and both formulations are well tolerated. Limitations of the study include enrollment of only patients who were already on treatment with brimonidine-purite 0.15%. The 0.1% formulation of brimonidine-purite allows for decreased exposure to brimonidine while providing an IOP-lowering effect comparable to that of the 0.15% formulation. Clinical trial registered at clinicaltrials.gov; identifier: NCT00168363.

Key words: :

• Brimonidine
• Eye
• Glaucoma
• Intraocular pressure (IOP)

Acknowledgments

Declaration of interest: This study was funded by Allergan, Inc. LBC has no proprietary interest in the study drugs. Medical writing assistance was provided by Elizabeth Davis, PhD, Pacific Communications, Costa Mesa, CA. The other authors are employees of Allergan, Inc.

The investigators (in alphabetical order): L. Cantor, J. Corwin, R. Gross, A. Kent, T. Mundorf, G. Nardin, K. Sall, H. Schenker, S. Simmons, S. Sonty, R. Sturm, R. Williams, and D. Wirta. Clinical trial registered at clinicaltrials.gov, identifier: NCT00168363.

Notes

* Alphagan is a registered trade name of Allergan, Inc., Irvine, CA, USA

† Purite is a registered trade name of Allergan, Inc., Irvine, CA, USA

‡ Alphagan P is a registered trade name of Allergan, Inc., Irvine, CA, USA