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One-Year, Randomized Study Comparing Bimatoprost and Timolol in Glaucoma and Ocular Hypertension
Eve J. Higginbotham, MD;
Joel S. Schuman, MD;
Ivan Goldberg, MBBS, FRANZCO;
Ronald L. Gross, MD;
Amanda M. VanDenburgh, PhD;
Kuankuan Chen, MS;
Scott M. Whitcup, MD;
for the Bimatoprost Study Groups 1 and 2
Arch Ophthalmol. 2002;120:1286-1293.
Objective To compare bimatoprost with timolol maleate in patients with glaucoma
or ocular hypertension.
Methods In 2 identical, multicenter, randomized, double-masked, 1-year clinical
trials, patients were treated with 0.03% bimatoprost once daily (QD) (n =
474), 0.03% bimatoprost twice daily (BID) (n = 483), or 0.5% timolol maleate
BID (n = 241).
Main Outcome Measures Diurnal intraocular pressure (IOP) at 8 AM, 10 AM, and 4 PM and safety
variables (IOP was also measured at 8 PM at selected sites).
Results Bimatoprost QD provided significantly lower mean IOP than timolol at
every time of the day at each study visit (P<.001).
This was also true for bimatoprost BID at most time points, but the efficacy
was not as good as that of the QD regimen. At 10 AM (peak timolol effect)
at month 12, the mean reduction in IOP from baseline was 7.6 mm Hg (30%) with
bimatoprost and 5.3 mm Hg (21%) with timolol (P<.001).
A significantly higher percentage of patients receiving bimatoprost QD (58%)
than timolol (37%) achieved IOPs at or below 17 mm Hg (10 AM, month 12; P<.001). The most common adverse effect with bimatoprost
was hyperemia (significantly higher with bimatoprost QD than timolol; P<.001).
Conclusions Bimatoprost QD provides sustained IOP lowering superior to timolol or
bimatoprost BID and achieves low target IOPs in significantly more patients.
From the Department of Ophthalmology, University of Maryland at Baltimore
(Dr Higginbotham); the New England Eye Center, New England Medical Center,
Tufts University School of Medicine, Boston, Mass (Dr Schuman); the Eye Associates
and Sydney Eye Hospital, Sydney, New South Wales (Dr Goldberg); the Department
of Ophthalmology, Baylor College of Medicine, Houston, Tex (Dr Gross); and
Allergan Inc, Irvine, Calif (Drs VanDenburgh and Whitcup and Mr Chen). Drs
Higginbotham, Schuman, Goldberg, Gross and the members of the study groups
were paid evaluators and do not have any financial or proprietary interest
in any of the drugs used in the study or in the study sponsor.
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