Two multicenter, randomized studies of the efficacy and safety of cyclosporine ophthalmic emulsion in moderate to severe dry eye disease
Two multicenter, randomized studies of the efficacy and safety of cyclosporine ophthalmic emulsion in moderate to severe dry eye disease
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DOI：
10.1016/s0161-6420(99)00176-1
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发表时间：
2000-04-01
期刊：
影响因子：
13.7
通讯作者：
Reis, BL
中科院分区：
文献类型：
--
作者：
Sall, K;Stevenson, OD;Reis, BL
目的：比较环孢菌素A（[CSA] 0.05％和0.1％眼科乳液的功效和安全性）与中度至重度干眼症患者的媒介物。 - 月经对照。参与者：总共有877例中度至重度干眼症患者（292至292至293在每个治疗组中）。方法：两项相同的临床试验；每天用CSA，0.05％或0.1％或车辆对患者进行两次治疗。这两项试验的结果合并进行分析。结果指标：疗效：角膜和脑膜染料染色，Schirmer泪液测试（有或没有麻醉），撕裂时间分解时间，眼表面疾病指数（OSDI），面部表达，，，，，面部表达患者主观评分量表，干眼症的症状，研究者对全球对治疗的反应的评估，治疗成功以及人工眼泪的日常使用。安全：发生不良事件，最校正的视力，眼压，生物显微镜和血液槽CSA浓度的发生。回报：使用CSA治疗，0.05％或0.1％，给予显着改善（P小于或等于0.05）在两个客观的眼睛疾病（角膜染色和分类的Schirmer值）中有两个客观迹象。 CSA 0.05％的治疗还可以在三种主观的干眼症（视力模糊，对伴随人造泪水的需求以及医生对全球对治疗反应的评估）中的三种主观测量中的改善（P <0.05）显着改善（P <0.05）。没有剂量反应效应。两种CSA治疗均表现出极好的安全性，并且没有明显的局部或全身不良安全发现。结论：新型眼科配方CSA 0.05％和0.1％可安全有效，可在中度至重度严重的干眼病治疗中得到改善客观和主观措施。局部CSA代表了一种基于药理学的新型治疗方法，可为干眼症疾病提供可观的患者益处。 （c）2000年美国眼科学会。
Objective: To compare the efficacy and safety of cyclosporin A ([CsA] 0.05% and 0.1% ophthalmic emulsions) to vehicle in patients with moderate to severe dry eye disease.Design: Multicenter, randomized, double-masked, parallel-group, 6-month, vehicle-controlled.Participants: A total of 877 patients with defined moderate to severe dry eye disease (292 to 293 in each treatment group).Methods: Two identical clinical trials; patients were treated twice daily with either CsA, 0.05% or 0.1%, or vehicle. The results of these two trials were combined for analysis.Main Outcome Measures: Efficacy: corneal and interpalpebral dye staining, Schirmer tear test (with and without anesthesia), tear break-up time, Ocular Surface Disease Index (OSDI), facial expression, patient subjective rating scale, symptoms of dry eye, investigator's evaluation of global response to treatment, treatment success, and daily use of artificial tears. Safety: occurrence of adverse events, best-corrected visual acuity, intraocular pressure, biomicroscopy, and blood trough CsA concentrations.Results: Treatment with CsA, 0.05% or 0.1%, gave significantly (P less than or equal to 0.05) greater improvements than vehicle in two objective signs of dry eye disease (corneal staining and categorized Schirmer values). CsA 0.05% treatment also gave significantly greater improvements (P < 0.05) in three subjective measures of dry eye disease (blurred vision, need for concomitant artificial tears, and the physician's evaluation of global response to treatment). There was no dose-response effect. Both CsA treatments exhibited an excellent safety profile, and there were no significant topical or systemic adverse safety findings.Conclusions: The novel ophthalmic formulations CsA 0.05% and 0.1% were safe and effective in the treatment of moderate to severe dry eye disease yielding improvements in both objective and subjective measures. Topical CsA represents a new pharmacologically based treatment for dry eye disease that may provide significant patient benefits. (C) 2000 by the American Academy of Ophthalmology.