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首页> 外文期刊>Acta ophthalmologica Scandinavica >Efficacy and safety of tafluprost 0.0015% versus latanoprost 0.005% eye drops in open-angle glaucoma and ocular hypertension: 24-month results of a randomized, double-masked phase III study
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Efficacy and safety of tafluprost 0.0015% versus latanoprost 0.005% eye drops in open-angle glaucoma and ocular hypertension: 24-month results of a randomized, double-masked phase III study

机译：tafluprost 0.0015％与latanoprost 0.005％滴眼剂在开角型青光眼和高眼压中的疗效和安全性：一项随机，双掩蔽的III期研究的24个月结果

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Purpose: The objective of the study was to compare the long-term efficacy and safety of tafluprost 0.0015% with latanoprost 0.005% eye drops in patients with open-angle glaucoma or ocular hypertension.Methods: This double-masked, active-controlled, parallel-group, multinational, multicentre, phase III study was conducted at 49 centres in 8 countries. Eligible patients were assigned to treatment administered once daily at 20:00 hrs for up to 24 months. Change from baseline intraocular pressure (IOP) was the primary efficacy variable. Adverse events were recorded and ocular safety was evaluated. Both tafluprost and latanoprost were preserved with benzalkonium chloride.Results: From 533 patients randomized, 402 patients completed 24 months of therapy. Both treatments had a substantial IOP-lowering effect which persisted throughout the study (-7.1 mmHg for tafluprost and -7.7 mmHg for latanoprost at 24 months). Although the IOP-lowering effect during the study was slightly larger with latanoprost, this difference was clinically small and the noninferiority of tafluprost to latanoprost over all diurnal IOP measurements was shown with anova and almost reached with ancova (upper limits of the 95% confidence intervals 1.38 and 1.52 for the overall period, respectively). The noninferiority limit was 1.5 mmHg.Conclusions: Tafluprost is a new effective and well-tolerated treatment for glaucoma and ocular hypertension.
机译：目的：本研究的目的是比较0.0015％的tafluprost和0.005％的拉坦前列素0.005％滴眼剂在开角型青光眼或高眼压患者中的长期疗效和安全性。在8个国家的49个中心进行了小组，跨国，多中心的第三阶段研究。符合条件的患者被分配到每天20:00进行一次治疗，长达24个月。与基线眼压（IOP）相比的变化是主要的疗效变量。记录不良事件并评估眼睛安全性。他克前列素和拉坦前列素均用苯扎氯铵保存。结果：从533例随机患者中，有402例患者完成了24个月的治疗。两种治疗均具有显着降低IOP的作用，并在整个研究过程中持续存在（在24个月时，tafluprost为-7.1 mmHg，latanoprost为-7.7 mmHg）。尽管拉坦前列素在研究过程中降低IOP的作用稍大，但这种差异在临床上很小，并且在所有昼夜IOP测量中，tafluprost对拉坦前列素的非劣效性均由方差分析显示，几乎与ancova达到（95％置信区间的上限）整个期间分别为1.38和1.52）。非劣效性限值为1.5 mmHg。结论：塔夫普罗斯特是一种治疗青光眼和高眼压症的有效且耐受良好的新疗法。

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