A multicenter, randomized, parallel-group, clinical trial comparing the safety and efficacy of loteprednol etabonate 0.5%/tobramycin 0.3% with dexamethasone 0.1%/tobramycin 0.3% in the treatment of Chinese patients with blepharokeratoconjunctivitis
A multicenter, randomized, parallel-group, clinical trial comparing the safety and efficacy of loteprednol etabonate 0.5%/tobramycin 0.3% with dexamethasone 0.1%/tobramycin 0.3% in the treatment of Chinese patients with blepharokeratoconjunctivitis
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DOI：
10.1185/03007995.2012.659723
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发表时间：
2012-03-01
影响因子：
2.3
通讯作者：
Zhong, Xingwu
中科院分区：
文献类型：
--
作者：
Chen, Minjie;Gong, Lan;Zhong, Xingwu
目的：比较0.5%依替泼诺/妥布霉素0.3%(LE/T)和地塞米松0.1%/妥布霉素0.3%(DM/T)滴眼液治疗眼部炎症相关性睑角化结膜炎(BKC)的疗效和安全性。研究设计与方法：本研究为多中心、随机、研究者掩蔽、平行分组临床试验。年龄>；=18岁且至少有一只眼临床诊断为BKC的患者接受了LE/T或DM/T治疗，每天4次，持续2周。在基线以及第3、8和15天(就诊2、3和4次)，对双眼的眼部体征和症状、视力(VA)、生物显微镜和眼压(IOP)进行临床评估。主要观察指标：主要疗效终点是指定研究眼的体征和症状综合评分从基线(CFB)变为就诊4分，使用非劣势指标比较LE/T和DM/T。安全性评估包括不良事件、生物显微镜检查结果以及VA和IOP的变化。临床试验登记：NCT编号，结果：共纳入308例患者(156例LE/T，152例DM/T)。在每次随访中，两种治疗方法的综合体征和症状均可见明显的CFB(p
Objective:To compare the efficacy and safety of loteprednol etabonate 0.5%/tobramycin 0.3% (LE/T) and dexamethasone 0.1%/tobramycin 0.3% (DM/T) ophthalmic suspensions in a Chinese population with ocular inflammation associated with blepharokeratoconjunctivitis (BKC).Research design and methods:This study was a multicenter, randomized, investigator-masked, parallel-group clinical trial. Patients aged >= 18 years with a clinical diagnosis of BKC in at least one eye received LE/T or DM/T administered 4 times daily for 2 weeks. At baseline and on days 3, 8, and 15 (visits 2, 3, and 4), clinical assessments of ocular signs and symptoms, visual acuity (VA), biomicroscopy, and intraocular pressure (IOP) were performed in both eyes.Main outcome measures:The primary efficacy endpoint was the change from baseline (CFB) to visit 4 in the signs and symptoms composite score in designated study eyes using a non-inferiority metric to compare LE/T to DM/T. Safety evaluation included adverse events, biomicroscopy findings, and changes in VA and IOP.Clinical trial registration:NCT number, NCT01028027.Results:A total of 308 patients were included in the per protocol population (n = 156 LE/T, n = 152 DM/T). A significant CFB in composite signs and symptoms was seen with both treatments at each follow-up visit (p