Alpern L, Bacharach J, Beck A, Brandt J, Brodstein D, Cantor L, Cooke D, Craven ER, Day D, Dirks M, DuBiner H, Duzman E, Evans R, Feldman R, Foerster R, Foley J, Fried W, Gendelman P, Gross R, Gurevich L, Park O, Hayes B, Katz J, Krishna R, Krug J, Lewis RA, Lin C, Lozier J, Mandell A, McGarey D, Mundorf T, Nardin G, Nussdorf J, Perez B, Price M, Realini A, Michael R, Sall K, Schenker H, Sharpe E, Sheppard J, Sherwood M, Shields R, Simmons S, Sokol J, Solish A, Sturm R, Tepedino M, Thorne G, Tibbetts JH, Walters T, Whiteside S, Wilensky J, Williams R, Williamson C, Rouge B, Wirta D, Wohl L, Blondeau P, Hutnik C.
Source
University of California, Davis, Sacramento, CA 95817-2307, USA. jdbrandt@ucdavis.edu
Abstract
PURPOSE:
To evaluate the safety and efficacy of a fixed combination (FC) of bimatoprost (BIM) and timolol (TIM) compared with each of the active components for 3 months.
PATIENTS AND METHODS:
Two double-masked, randomized, multicenter parallel studies of FC (once-daily, mornings), BIM (once-daily, evenings), or TIM (twice-daily) were conducted in 1061 patients with glaucoma or ocular hypertension.
RESULTS:
Mean diurnal decreases from baseline intraocular pressure (IOP) at month 3 were 8.1, 7.9, and 6.4 mm Hg for the FC, BIM, and TIM groups, respectively. The proportion of patients with a mean diurnal percent reduction from baseline in IOP of more than 20% across all visits was 81.8% (436/533), 72.1% (191/265), and 49.8% (131/263) for the FC, BIM, and TIM groups, respectively (P<0.001 for FC vs. BIM and FC vs. TIM). The proportion of patients achieving an IOP of less than 18 mm Hg at all time points was 39.2% (209/533), 28.7% (76/265), and 12.2% (32/263) for the FC, BIM, and TIM groups, respectively (P=0.003 for FC vs. BIM, and P<0.001 for FC vs. TIM). The most commonly reported treatment-related adverse event was conjunctival hyperemia, with the greatest incidence in BIM (38.5%, 102/265), followed by FC (22.7%, 121/533, P<0.0001 vs. BIM) and TIM (6.8%, 18/263; P<0.001 vs. FC).
CONCLUSIONS:
FC was statistically significantly more effective than BIM or TIM for most comparisons, and safer than BIM with respect to common ocular adverse events. FC represents a convenient, therapeutic advantage over separate bottles.