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立他司特滴眼液在健康受试者体内的安全性及药代动力学特征的临床试验
[Translation] A clinical trial of the safety and pharmacokinetic characteristics of Litahast eye drops in healthy subjects
主要目的:评价立他司特滴眼液在中国健康受试者中给药后的药代动力学特征。
次要目的:评价立他司特滴眼液在中国健康受试者中给药后的安全性。
[Translation] Main objective: To evaluate the pharmacokinetic characteristics of ritazast eye drops after administration in Chinese healthy subjects.
Secondary objective: To evaluate the safety of ritazast eye drops after administration in Chinese healthy subjects.
立他司特滴眼液用于治疗干眼症的有效性和安全性的多中心、随机、双盲、安慰剂对照的 III 期临床试验
[Translation] A multicenter, randomized, double-blind, placebo-controlled phase III clinical trial of the efficacy and safety of lipastat eye drops for the treatment of dry eye
通过测量在治疗 84 天后,试验组和安慰剂组下角膜荧光素染色评分(ICSS)较基线的改变均值,评估立他司特滴眼液与安慰剂相比在改善干眼症(DED)体征方面的疗效。
[Translation] The improvement of dry eye syndrome (DED) signs of lipamilast eye drops compared with placebo was assessed by measuring the mean change from baseline in corneal fluorescein staining score (ICSS) in the experimental and placebo groups after 84 days of treatment aspect of curative effect.
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