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干眼病患者SJP-0132的有效性和安全性:一个2b期随机,双面罩,剂量检测研究

Yuichi Hori¹, Tomoyuki Wada², Kazunori Omatsu²

¹Department of Ophthalmology (Y.H.), Toho University Faculty of Medicine, Tokyo, Japan.

American journal of ophthalmology

|December 6, 2025

概括

TRPV1 抗剂 SJP-0132 眼科悬浮液在干眼疾病中表现出剂量依赖的疗效和安全性. 根据观察到的益处,确定0.3%的剂量是进一步开发的最佳剂量.

科学领域:

眼科医生眼科眼科
药理学药理学是指药理学的学科.

背景情况:

干眼病 (DED) 是一种普遍存在的眼表面疾病,其特点是不适和视觉障碍.
目前对DED的治疗方法旨在缓解症状并改善眼睛表面的完整性.

研究的目的:

为了评估SJP-0132眼科悬浮剂的疗效,安全性和最佳剂量,TRPV1抗剂,在被诊断为DED的患者中.
确定SJP-0132的剂量反应关系,以改善DED的主观和客观测量.

主要方法:

在日本进行了一项随机,双面罩,多中心,安慰剂控制的2b期研究.
344名DED的门诊患者随机分配给接受SJP-0132 (0.1%,0.3%,或1.0%) 或安慰剂,每天四次,持续4周.
主要疗效终点是从基线到第4周的角膜光素染色 (CFS) 评分的变化.

主要成果:

在SJP-0132 (0.3%) 和安慰剂之间没有观察到主要终点 (CFS得分) 的统计学上显著差异.
二级终点表明干眼症状,生活质量和客观症状的改善通常取决于剂量,在某些措施中与安慰剂有统计学上显著的差异.
SJP-0132耐受性良好,亚组分析表明,0.3%剂量在特定患者群体中具有潜在的益处.

结论:

在患有DED的患者中,SJP-0132表现出剂量依赖的疗效和有利的安全概况.
由于观察到的安全性和治疗益处,SJP-0132眼科悬浮剂的0.3%剂量被认为是进一步临床开发的最佳剂量.

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