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  • Title: Latanoprost and timolol combination therapy vs monotherapy: one-year randomized trial.
    Author: Higginbotham EJ, Feldman R, Stiles M, Dubiner H, Fixed Combination Investigative Group.
    Journal: Arch Ophthalmol; 2002 Jul; 120(7):915-22. PubMed ID: 12096962.
    Abstract:
    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.
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