Abstract：
OBJECTIVE: To comprehensively review the efficacy and safety of OC-01 varenicline nasal spray versus vehicle nasal spray (VNS) in the treatment in dry eye disease (DED).
METHODS: A systematic review that included full-length randomized controlled studies (RCTs), as well as post hoc analyses of RCTs reporting new findings on OC-01 VNS treatment in three databases, PubMed, Scopus and Web of Science, was performed according to the PRISMA statement. The search period included studies published between December 2021 and September 2023. The Cochrane risk of bias tool was used to analyze the quality of the studies selected.
RESULTS: A total of 8 studies were included in this systematic review. OC-01 VNS treatment achieved higher improvement than vehicle in all reported variables. The mean differences between both groups were in favor of OC-01 VNS treatment and were as follow: eye dryness score base on a visual analogue scale (EDS-VAS) of -7.5 ± 2.2 points [-11.6 to -5.6], Schirmer test (ST) with anesthesia of 6.6 ± 2.3 mm [4.9 to 11.8] and total corneal fluorescein staining (tCFS) of -1.2 ± 0.01 points [-1.2 to -1.1]. Similar improvements were reported with OC-01 VNS 0.03 mg and 0.06 mg. Adverse events (AEs) were 15.5 ± 19.4 % [-13 to 80.5] higher in the OC-01 VNS group with an overall adherence > 93 %.
CONCLUSIONS: OC-01 VNS improves dry eye symptoms and signs with a satisfactory tolerability. Therefore, OC-01 VNS seems to be a safe and effective treatment that could be recommended in patients with DED. This new treatment could be particularly useful in those patients who have difficulties with the administration of traditional topical therapies.
METHODS: A systematic review that included full-length randomized controlled studies (RCTs), as well as post hoc analyses of RCTs reporting new findings on OC-01 VNS treatment in three databases, PubMed, Scopus and Web of Science, was performed according to the PRISMA statement. The search period included studies published between December 2021 and September 2023. The Cochrane risk of bias tool was used to analyze the quality of the studies selected.
RESULTS: A total of 8 studies were included in this systematic review. OC-01 VNS treatment achieved higher improvement than vehicle in all reported variables. The mean differences between both groups were in favor of OC-01 VNS treatment and were as follow: eye dryness score base on a visual analogue scale (EDS-VAS) of -7.5 ± 2.2 points [-11.6 to -5.6], Schirmer test (ST) with anesthesia of 6.6 ± 2.3 mm [4.9 to 11.8] and total corneal fluorescein staining (tCFS) of -1.2 ± 0.01 points [-1.2 to -1.1]. Similar improvements were reported with OC-01 VNS 0.03 mg and 0.06 mg. Adverse events (AEs) were 15.5 ± 19.4 % [-13 to 80.5] higher in the OC-01 VNS group with an overall adherence > 93 %.
CONCLUSIONS: OC-01 VNS improves dry eye symptoms and signs with a satisfactory tolerability. Therefore, OC-01 VNS seems to be a safe and effective treatment that could be recommended in patients with DED. This new treatment could be particularly useful in those patients who have difficulties with the administration of traditional topical therapies.
摘要：
目的：综合评价OC-01伐伦克林鼻喷雾剂与载体鼻喷雾剂(VNS)治疗干眼病(DED)的疗效和安全性。
方法：包括全长随机对照研究（RCT）的系统综述，以及在三个数据库中报告OC-01VNS治疗新发现的RCT的事后分析，PubMed,Scopus和WebofScience,是根据PRISMA声明执行的。搜索期包括2021年12月至2023年9月之间发表的研究。使用Cochrane偏倚风险工具分析所选研究的质量。
结果：本系统综述共纳入8项研究。OC-01VNS治疗在所有报告的变量中实现了比媒介物更高的改善。两组之间的平均差异有利于OC-01VNS治疗，如下：基于视觉模拟评分（EDS-VAS）的-7.5±2.2分[-11.6至-5.6]的眼睛干燥评分，Schirmer试验（ST），麻醉为6.6±2.3mm[4.9至11.8]，全角膜荧光素染色（tCFS）为-1.2±0.01分[-1.2至-1.1]。用0.03mg和0.06mg的OC-01VNS报道了类似的改善。OC-01VNS组的不良事件（AE）高15.5±19.4％[-13至80.5]，总体依从性>93％。
结论：OC-01VNS可改善干眼症状和体征，耐受性令人满意。因此,OC-01VNS似乎是一种安全有效的治疗方法，可推荐用于DED患者。这种新的治疗方法对那些难以施用传统局部治疗的患者特别有用。
方法：包括全长随机对照研究（RCT）的系统综述，以及在三个数据库中报告OC-01VNS治疗新发现的RCT的事后分析，PubMed,Scopus和WebofScience,是根据PRISMA声明执行的。搜索期包括2021年12月至2023年9月之间发表的研究。使用Cochrane偏倚风险工具分析所选研究的质量。
结果：本系统综述共纳入8项研究。OC-01VNS治疗在所有报告的变量中实现了比媒介物更高的改善。两组之间的平均差异有利于OC-01VNS治疗，如下：基于视觉模拟评分（EDS-VAS）的-7.5±2.2分[-11.6至-5.6]的眼睛干燥评分，Schirmer试验（ST），麻醉为6.6±2.3mm[4.9至11.8]，全角膜荧光素染色（tCFS）为-1.2±0.01分[-1.2至-1.1]。用0.03mg和0.06mg的OC-01VNS报道了类似的改善。OC-01VNS组的不良事件（AE）高15.5±19.4％[-13至80.5]，总体依从性>93％。
结论：OC-01VNS可改善干眼症状和体征，耐受性令人满意。因此,OC-01VNS似乎是一种安全有效的治疗方法，可推荐用于DED患者。这种新的治疗方法对那些难以施用传统局部治疗的患者特别有用。
