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J. A. Stewart, B. Cvenkel, L. A. Nelson, W. C. Stewart; Dorzolamide/Timolol Maleate Fixed Combination Given Twice Daily versus Latanoprost/Timolol Maleate Fixed Combination Given Once Every Morning in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension. Invest. Ophthalmol. Vis. Sci. 2007;48(13):5562.
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To evaluate the efficacy and safety of dorzolamide/timolol maleate fixed combination (DTFC) given twice daily versus latanoprost/timolol maleate fixed combination (LTFC) given once every morning following a run-in period with timolol maleate gel forming solution given once daily in patients with primary open-angle glaucoma or ocular hypertension.
A prospective, double-masked, randomized, active-controlled, two-period, crossover comparison in which eligible patients were begun on timolol maleate gel forming solution given once daily and returned in six weeks for baseline examinations. Patients underwent diurnal curve testing following the 8 AM trough intraocular pressure (IOP) measurement every two hours until 8 PM. Patients with an 8 AM IOP of 20 to 32 mm Hg inclusive after dosing with timolol maleate gel forming solution prior to the 8 AM dose were randomized to either DTFC given twice daily or LTFC given every morning and placebo in the evening for six weeks. Patients returned for the end of Period 1 diurnal curve. Patients were then switched to opposite treatment for Period 2 for six weeks and returned for the end of Period 2 diurnal curve.
Twenty-six patients were included in this study. The primary efficacy variable, the diurnal IOP, was 19.0 ± 2.9 mm Hg for DTFC and 18.5 ± 2.8 mm Hg for LTFC (P = 0.18). The IOPs for each time point are shown in the Table. There was no significant difference found between DTFC and LTFC using a paired t-test within the ANOVA model for each time point following a Bonferroni correction of α/4. The most common side effects were blurring (n = 1) and burning (n = 1) both with LTFC. There were no patient discontinuations.
This study suggests that patients treated with DTFC given twice daily and LTFC given once every evening have statistically similar efficacy and safety.Table: Intraocular pressures (mm Hg ± standard deviation)
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