A comparative clinical trial of the efficacy of two different aqueous solutions of cyclosporine for the treatment of moderate-to-severe dry eye syndrome

A comparative clinical trial of the efficacy of two different aqueous solutions of cyclosporine for the treatment of moderate-to-severe dry eye syndrome
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DOI:
10.1136/bjo.2008.150011
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发表时间:
2010-10-01
影响因子:
4.1
通讯作者:
Felix Alaniz-de la O, J.
Felix Alaniz-de la O, J.
中科院分区:
医学2区
文献类型:
--
作者:
Baiza-Duran, Leopoldo;Medrano-Palafox, Javier;Felix Alaniz-de la O, J.

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目的 评价两种不同浓度的环孢素 A (CsA) 水溶液与赋形剂相比对干眼综合征患者的疗效和安全性。设计多中心、随机、双盲、赋形剂对照临床试验。方法 共有 183 名患者入组,并随机分为 CsA 1%(A 组)、CsA 0.05%(B 组)或仅赋形剂(C 组)。主要目的是评估 CsA 水溶液在减少中度至重度干眼病患者体征和症状方面的功效。 结果 早期(第 21 天)统计显着改善(p
Objective To evaluate the efficacy and safety of two different concentrations of cyclosporine A (CsA) in aqueous solution compared to vehicle in patients with dry eye syndrome.Design Multicentre, randomised, double-masked, vehicle-controlled, clinical trial.Methods A total of 183 patients were enrolled and randomised to either CsA 1% (group A), CsA 0.05% (group B) or vehicle only (group C). The main objective was to evaluate the efficacy of CsA aqueous solution in the reduction of signs and symptoms in patients with moderate to severe dry eye disease.Results An early (day 21) statistically significant improvement (p