Baiza-Durán Leopoldo Martín, Llamas-Moreno Juan Francisco, Ayala-Barajas Clotilde
Clinical Research Department, Laboratorios Sophia, SA de CV Guadalajara, Jalisco, México.
Clin Ophthalmol. 2012;6:1051-5. doi: 10.2147/OPTH.S33578. Epub 2012 Jul 11.
The purpose of this study was to evaluate the efficacy and safety of two fixed combinations, ie, timolol 0.5% + brimonidine 0.2% + dorzolamide 2% (TBD) versus timolol 0.5% + brimonidine 0.2% (TB) in patients with primary open-angle glaucoma or ocular hypertension.
We performed a 3-month, randomized, double-blind study in patients with primary open-angle glaucoma or ocular hypertension and an intraocular pressure of 21-30 mmHg. Patients were randomly assigned to receive one drop of TBD or TB twice a day. The primary efficacy endpoint was change in intraocular pressure after 3 months of treatment. Safety measures were assessed by the presence of adverse events.
Mean baseline intraocular pressure was similar at 8 am and 4 pm in the treatment groups (TBD 22.3 ± 0.9 mmHg, TB 22.4 ± 1.8 mmHg, P = 0.558; TBD 19.02 ± 1.3, TB 19.08 ± 1.2, P = 0.536, respectively). At the end of the study, the mean intraocular pressure was significantly lower in the TBD group at both 8 am (16.19 ± 2.0 mmHg versus 18.35 ± 1.4 mmHg, P = 0.000) and 4 pm (14.74 ± 2.4 mmHg versus 16.77 ± 1.4 mmHg, P = 0.000).
Fixed-combination TBD was more effective than fixed-combination TB for reducing IOP in patients with primary open-angle glaucoma.
本研究旨在评估两种固定复方制剂，即0.5%噻吗洛尔+0.2%溴莫尼定+2%多佐胺（TBD）与0.5%噻吗洛尔+0.2%溴莫尼定（TB）治疗原发性开角型青光眼或高眼压症患者的疗效和安全性。
我们对原发性开角型青光眼或高眼压症且眼压为21 - 30 mmHg的患者进行了为期3个月的随机双盲研究。患者被随机分配，每天两次，每次一滴TBD或TB。主要疗效终点是治疗3个月后的眼压变化。通过不良事件的发生情况评估安全性指标。
治疗组上午8点和下午4点的平均基线眼压相似（TBD组为22.3±0.9 mmHg，TB组为22.4±1.8 mmHg，P = 0.558；TBD组为19.02±1.3，TB组为19.08±1.2，P = 0.536）。研究结束时，TBD组上午8点（16.19±2.0 mmHg对18.35±1.4 mmHg，P = 0.000）和下午4点（14.74±2.4 mmHg对16.77±1.4 mmHg，P = 0.000）的平均眼压均显著更低。
在原发性开角型青光眼患者中，固定复方制剂TBD在降低眼压方面比固定复方制剂TB更有效。
