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Latanoprost and Timolol Combination Therapy vs Monotherapy
One-Year Randomized Trial
Eve J. Higginbotham, MD;
Robert Feldman, MD;
Michael Stiles, MD;
Harvey Dubiner, MD;
for the Fixed Combination Investigative Group
Arch Ophthalmol. 2002;120:915-922.
Objective To compare the efficacy and safety of a fixed combination of 0.005%
latanoprost and 0.5% timolol maleate administered once daily vs monotherapy
with either 0.005% latanoprost once daily or 0.5% timolol twice daily.
Methods Patients with either primary or secondary open-angle glaucoma or ocular
hypertension participated in a 6-month, randomized, double-masked, multicenter
study with 3 parallel treatment groups. The double-masked period was preceded
by a 2- to 4-week "run-in" treatment with timolol. Subjects could receive
fixed combination therapy during a 6-month open-label extension.
Main Outcome Measure The difference between groups in mean diurnal intraocular pressure reduction
in study eye(s) from baseline through 6 months of treatment.
Results Overall, 418 patients were enrolled in the study; 332 completed the
open-label phase. Diurnal intraocular pressure levels were similar at baseline,
but at week 26, they were 19.9 ± 3.4 mm Hg in the fixed combination
therapy group, 20.8 ± 4.6 mm Hg in latanoprost-treated patients, and
23.4 ± 5.4 mm Hg in timolol-treated patients (data are given as mean
± SD). The mean change from baseline was greater among patients receiving
fixed combination therapy compared with each monotherapy group (P<.01). Fixed combination therapy effectively lowered intraocular
pressure levels for up to 1 year. All treatments were well tolerated.
Conclusion The combination of 0.005% latanoprost and 0.5% timolol administered
once daily is effective and well tolerated for up to 12 months.
From the Department of Ophthalmology, The University of Maryland School
of Medicine, Baltimore (Dr Higginbotham), and the Department of Ophthalmology
and Visual Sciences, The University of TexasHouston Medical School
(Dr Feldman). Drs Stiles and Dubiner are in private practice in Kansas City,
Mo, and Morrow, Ga, respectively.
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