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首页> 外文期刊>Clinical ophthalmology >A randomized, double-masked, parallel-group, comparative study to evaluate the clinical efficacy and safety of 1% azithromycin–0.1% dexamethasone combination compared to 1% azithromycin alone, dexamethasone 0.1% alone, and vehicle in the treatment of subjects with blepharitis
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A randomized, double-masked, parallel-group, comparative study to evaluate the clinical efficacy and safety of 1% azithromycin–0.1% dexamethasone combination compared to 1% azithromycin alone, dexamethasone 0.1% alone, and vehicle in the treatment of subjects with blepharitis

机译：一项随机，双掩盖，平行组的对比研究，评估1％阿奇霉素-0.1％地塞米松联合用药与单独使用1％阿奇霉素，单独使用地塞米松0.1％和溶媒治疗睑缘炎患者的临床疗效和安全性

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Purpose: To evaluate the clinical efficacy and safety of a 1% azithromycin–0.1% dexamethasone combination in DuraSite (“combination”) compared to 0.1% dexamethasone in DuraSite, 1% azithromycin in DuraSite, and vehicle in the treatment of subjects with blepharitis. Materials and methods: This was a Phase III, double-masked, vehicle-controlled, four-arm study in which 907 subjects with blepharitis were randomized to combination (n=305), 0.1% dexamethasone (n=298), 1% azithromycin (n=155), or vehicle (n=149). Ten study visits were scheduled: screening visit, days 1 and 4 (dosing phase) and 15, and months 1–6 (follow-up phase). On day 1, subjects applied one drop of the study drug to the eyelid of the inflamed eye(s) twice daily, and continued with twice-daily dosing for 14 days. After completing 14 days of dosing, subjects were followed for 6 months for efficacy and safety. Results: A total of 57 subjects (6.3%) had complete clinical resolution at day 15: 25 (8.2%), 17 (5.7%), 8 (5.2%), and 7 (4.7%) subjects in the combination-, 0.1% dexamethasone-, 1% azithromycin-, and vehicle-treatment groups, respectively. The combination was superior to 1% azithromycin and vehicle alone, but not to 0.1% dexamethasone alone. Mean composite (total) clinical sign and symptom scores improved in all four treatment groups during the posttreatment evaluation phase for the intent-to-treat population, but outcomes were superior when a drop containing 0.1% dexamethasone was utilized. Clinical response was noted as early as day 4, and persisted as long as 6 months. Most adverse events were considered mild in severity and not related to the study drug. Conclusion: A higher percentage of subjects in the combination group achieved complete clinical resolution of the signs and symptoms of blepharitis at day 15 than with 1% azithromycin and vehicle, but outcomes were similar to treatment with 0.1% dexamethasone alone. The combination was well tolerated.
机译：目的：评价DuraSite中1％阿奇霉素-0.1％地塞米松组合（“组合”）与DuraSite中0.1％地塞米松，DuraSite中1％阿奇霉素和媒介物治疗睑缘炎的临床疗效和安全性。材料和方法：这是一项III期，双掩蔽，车辆控制的四臂研究，其中907例睑缘炎患者随机分组（n = 305），0.1％地塞米松（n = 298），1％阿奇霉素（n = 155）或车辆（n = 149）。计划进行10次研究访问：筛查访问，第1天和第4天（给药阶段）和第15天以及第1-6个月（随访阶段）。在第1天，受试者每天两次将一滴研究药物滴入发炎的眼睛的眼睑，并继续每天两次给药，持续14天。在完成14天的给药后，为了有效性和安全性对受试者进行6个月的随访。结果：在第15天，共有57位受试者（6.3％）拥有完全的临床缓解：组合中的25位（25％（8.2％），17位（5.7％），8位（5.2％）和7位（4.7％））- ％地塞米松，1％阿奇霉素和媒介物治疗组。该组合优于单独使用1％阿奇霉素和赋形剂，但不优于单独使用0.1％地塞米松。在意向治疗人群的治疗后评估阶段，所有四个治疗组的平均综合（总）临床体征和症状评分均得到改善，但当使用含0.1％地塞米松的滴剂时，结局则更好。最早在第4天就注意到了临床反应，并持续了长达6个月。大多数不良事件的严重程度被认为是轻度的，与研究药物无关。结论：与1％阿奇霉素和赋形剂相比，组合组在第15天达到眼睑炎症状和体征的完全临床解决的百分比更高，但结局与仅使用0.1％地塞米松治疗相似。该组合耐受良好。

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