This Article  • Full text  • PDF  • Reply to article  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on ISI (10)  • Contact me when this article is cited  Related Content  • Related letters  • Similar articles in this journal  Topic Collections  • Drug Therapy, Other  • Hypertension  • Articles for Residents  • Glaucoma  • Ophthalmological Disorders, Other  • Drug Therapy  • Alert me on articles by topic

A 12-Month Randomized Trial

Mark B. Sherwood, MD; E. Randy Craven, MD; Connie Chou, PhD; Harvey B. DuBiner, MD; Amy L. Batoosingh, BA; Rhett M. Schiffman, MD, MS, MHSA; Scott M. Whitcup, MD; for the Combigan Study Groups I and II

Arch Ophthalmol. 2006;124:1230-1238.

Objective  To evaluate the intraocular pressure (IOP)–lowering efficacy and safety of a fixed combination of 0.2% brimonidine tartrate and 0.5% timolol maleate (fixed brimonidine-timolol) compared with the component medications.

Methods  In 2 identical, 12-month, randomized, double-masked multicenter trials, patients with ocular hypertension or glaucoma were treated with fixed brimonidine-timolol twice daily (n = 385), 0.2% brimonidine tartrate 3 times daily (n = 382), or 0.5% timolol maleate twice daily (n = 392).

Main Outcomes Measures  Mean change from baseline IOP and incidence of adverse events.

Results  The mean decrease from baseline IOP during 12-month follow-up was 4.4 to 7.6 mm Hg with fixed brimonidine-timolol, 2.7 to 5.5 mm Hg with brimonidine, and 3.9 to 6.2 mm Hg with timolol. Mean IOP reductions were significantly greater with fixed brimonidine-timolol compared with timolol at all measurements (P.002) and brimonidine at 8 AM, 10 AM, and 3 PM (P<.001) but not at 5 PM. The incidence of treatment-related adverse events in the fixed-combination group was lower than that in the brimonidine group (P = .006) but higher than that in the timolol group (P<.001). The rate of discontinuation for adverse events was 14.3% with the fixed combination, 30.6% with brimonidine, and 5.1% with timolol.

Conclusions  Twice-daily fixed brimonidine-timolol therapy provides sustained IOP lowering superior to monotherapy with either thrice-daily brimonidine or twice-daily timolol and is better tolerated than brimonidine but less well tolerated than timolol.

Application to Clinical Practice  Fixed brimonidine-timolol is an effective and convenient IOP-lowering therapy.

Author Affiliations: Department of Ophthalmology, University of Florida College of Medicine, Gainesville (Dr Sherwood); Glaucoma Consultants of Colorado, Littleton (Dr Craven); Allergan Inc, Irvine, Calif (Drs Chou, Schiffman, and Whitcup and Ms Batoosingh); and Clayton Eye Center, Morrow, Ga (Dr DuBiner).

RELATED LETTERS

Reduced Ocular Allergy With Fixed-Combination 0.2% Brimonidine–0.5% Timolol
Jorge A. Alvarado
Arch Ophthalmol. 2007;125(5):717.
EXTRACT | FULL TEXT  

Reduced Ocular Allergy With Fixed-Combination 0.2% Brimonidine–0.5% Timolol—Reply
Mark B. Sherwood, E. Randy Craven, Connie Chou, Harvey B. DuBiner, Amy L. Batoosingh, Rhett M. Schiffman, and Scott M. Whitcup
Arch Ophthalmol. 2007;125(5):717-718.
EXTRACT | FULL TEXT  

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Reduced Ocular Allergy With Fixed-Combination 0.2% Brimonidine-0.5% Timolol
Alvarado
Arch Ophthalmol 2007;125:717-717.
FULL TEXT  

Reduced Ocular Allergy With Fixed-Combination 0.2% Brimonidine-0.5% Timolol--Reply
Sherwood et al.
Arch Ophthalmol 2007;125:717-718.
FULL TEXT