Control of intraocular pressure and fluctuation with fixed-combination brimonidine-timolol versus brimonidine or timolol monotherapy.

Author(s): Spaeth GL, Bernstein P, Caprioli J, Schiffman RM

Affiliation(s): Wills Eye Institute, Philadelphia, Pennsylvania 19107-5109, USA. gspaeth@willseye.org

Publication date & source: 2011-01, Am J Ophthalmol., 151(1):93-99.e4.

Publication type: Clinical Trial, Phase III; Comparative Study; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

PURPOSE: To evaluate control of intraocular pressure (IOP) and IOP fluctuation in patients with ocular hypertension or glaucoma treated with fixed-combination brimonidine-timolol compared with brimonidine or timolol monotherapy. DESIGN: Post hoc analysis of data from 2 identical, 12-month, randomized, double-masked, multicenter trials. METHODS: Patients were treated bilaterally with fixed brimonidine-timolol twice a day (n = 385), brimonidine tartrate 0.2% 3 times a day (n = 382), or timolol 0.5% twice a day (n = 392). Diurnal IOP was measured at follow-up visits at weeks 2 and 6 and months 3, 6, 9, and 12. IOP fluctuation was defined as the standard deviation of IOP measurements. RESULTS: The percentage of patients with mean diurnal IOP <18 mm Hg and short-term (daily) IOP fluctuation </=2 mm Hg was statistically significantly higher in the brimonidine-timolol group than in the brimonidine or timolol group at each follow-up visit (at month 12, brimonidine-timolol 43.0%; brimonidine 18.9%, timolol 33.5%, P </= .017). At each hour (8 AM, 10 AM, 3 PM, and 5 PM), the percentage of patients with mean IOP <18 mm Hg and long-term (intervisit) IOP fluctuation </=2 mm Hg was statistically significantly higher with brimonidine-timolol than with brimonidine or timolol alone (at 8 AM, brimonidine-timolol 41.0%, brimonidine 11.3%, timolol 23.7%, P < .001). CONCLUSIONS: Patients treated with fixed-combination brimonidine-timolol were more likely than patients treated with either brimonidine or timolol alone to achieve a combination of low mean IOP and low short-term (daily) or long-term (intervisit) IOP fluctuation. Copyright (c) 2011 Elsevier Inc. All rights reserved.