An Evaluation of Therapeutic Noninferiority of 0.005% Latanoprost Ophthalmic Solution and Xalatan in Patients With Glaucoma or Ocular Hypertension
An Evaluation of Therapeutic Noninferiority of 0.005% Latanoprost Ophthalmic Solution and Xalatan in Patients With Glaucoma or Ocular Hypertension
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DOI：
10.1097/ijg.0b013e318259b47c
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发表时间：
2013-12-01
影响因子：
2
通讯作者：
Rossetti, Luca
中科院分区：
文献类型：
--
作者：
Digiuni, Maurizio;Manni, Gianluca;Rossetti, Luca
目的：评估0.005%拉坦前列素滴眼液与Xalatan在治疗原发性开角型青光眼或高眼压症患者中的非劣效性。患者和方法：这是一项双盲、随机、多中心研究。共184例诊断为单侧或双侧原发性开角型青光眼或高眼压症的患者被随机分配至0.005%拉坦前列素滴眼液或Xalatan治疗12周。主要终点是两组在12周时眼内压（IOP）的变化。如果调整后的治疗平均值之间的差异的双侧95%置信区间（CI）完全在-1.5至+1.5 mmHg的区间内，则达到非劣效性。（95% CI：-0.47，0.71），符合方案人群中为0 mmHg（95% CI：-0.58，0.57）。在药物相关不良事件方面，两组之间无统计学显著差异。最常报告的药物相关的局部不良事件是：眼充血，睫毛生长，和眼睛irritation.Conclusions：这项研究表明，0.005%拉坦前列素滴眼液是非劣效于Xalatan在降低眼压，一般耐受性良好。
Purpose:To assess the therapeutic noninferiority of 0.005% latanoprost ophthalmic solution versus Xalatan in the treatment of patients with primary open-angle glaucoma or ocular hypertension.Patients and Methods:This was a double-masked, randomized, multicenter study. A total of 184 patients with a diagnosis of unilateral or bilateral primary open-angle glaucoma or ocular hypertension were randomly assigned to either 0.005% latanoprost ophthalmic solution or Xalatan for 12 weeks. The primary end-point was the change in intraocular pressure (IOP) at 12 weeks in the 2 groups. Noninferiority was reached if the 2-sided 95% confidence intervals (CI) for the difference between adjusted treatment means were entirely within the interval from -1.5 to +1.5 mm Hg.Results:The difference between treatments in the change of IOP from baseline to the end of treatment was 0.12 mm Hg (95% CI: -0.47, 0.71) in the intention-to-treat population and 0 mm Hg (95% CI: -0.58, 0.57) in the per protocol population. There was no statistically significant difference between the 2 groups in terms of drug-related adverse events. The most commonly reported drug-related local adverse events were: ocular hyperemia, eyelashes growth, and eye irritation.Conclusions:This study demonstrates that 0.005% latanoprost ophthalmic solution is noninferior to Xalatan in lowering IOP and is generally well tolerated.