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Enyr S. Arcieri, Ana Cláudia A. Pereira, Antônio E. Pereira, Rafael S. Arcieri; Efficacy and Safety of Fixed Combinations of Prostaglandin Analogues with Timolol Maleate in Primary Open Angle Glaucoma and Ocular Hypertension. Invest. Ophthalmol. Vis. Sci. 2011;52(14):232.
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To evaluate the efficacy and safety of three fixed combination of prostaglandin analogues with timolol maleate currently available in Brazil [bimatoprost with timolol (BT) - Ganfort, latanoprost with timolol (LT) - Xalacom, and travoprost with timolol (TT) - Duo-Travatran] in primary open angle glaucoma (POAG) or ocular hypertension (OHT) subjects.
Forty-six phakic patients (92 eyes) with POAG or OHT were enrolled in this prospective, randomized, masked-observer, parallel group study. Patients were randomized to use BT, LT or DT once daily for 2 months. Patients in each group were also randomized to instill the fixed combination at 8:00 am or 8:00 pm during the first 30-days period and after that they started the opposite medication time for the second 30-days period. Intraocular pressure (IOP) was measured at 8:00 am, 12:00 pm, and 4:00 pm at baseline and at the end of each treatment period. Unsolicited ocular adverse events were also recorded.
The baseline mean diurnal IOP was 21.84 ± 3.84 mmHg for BT, 21.82 ± 4.04 mmHg for LT, and 22.42 ± 3.90 mmHg for TT (p=0.7972). All fixed combinations significantly reduced IOP compared with baseline (p<0.00001). The mean diurnal IOP following therapy was 14.31 ± 1.71 mmHg for BT, 14.47 ± 2.39 mmHg for LT, and 14.27 ± 2.01 mmHg for TT at one month (p=0.9200); and 14.45 ± 1.81 mmHg for BT, 14.51 ± 2.62 mmHg for LT, and 14.13 ± 2.01 mmHg for TT at two months (p=0.7675). The IOP reduction did not differ statistically between groups at all time intervals (p>0.2015). Overall, 15 subjects complained about ocular adverse events at one month (6 for BT, 3 for LT and 6 for TT - p=0.1172), and 10 at two months (3 for BT, 2 for LT and 5 for TT - p=0.1334). The most commonly reported treatment-related adverse event was conjunctival hyperemia. At two months, BT (2) and TT (4) caused more ocular hyperemia than LT (0) (p=0.0356). There were no statistically significant differences between IOP reduction or incidence of treatment-related adverse event according to time of instilling the eye drops (morning or evening) among the groups (p>0.0676).
This study suggests that BT, LT and TT, regardless if instilled at morning or at evening, have similar efficacy in POAG or OHT subjects.
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