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Varenicline solution nasal spray for dry eye disease in Chinese patients: a randomized phase 3 trial

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收录情况： ◇ SCIE ◇ SSCI

作者：
Tian Lei[1] * ; Jin Xiuming[2] ; Wang Jibing[3] ; Xu Yonggen[4] ; Lu Chengwei[5] ; Zhao Shaozhen[6] ; Zhu Qian[7] ; Dai Hong[8] ; Gu Hao[9] ; Zhang Mingchang[10] ; Wang Linnong[11] ; Lu Xiaohe[12] ; Ma Lixiao[13] ; Zhu Lei[14] ; Zeng Qingyan[15] ; Zhang Hong[16] ; Fu Yao[17] ; Li Suxia[18] ; Tao Liming[19] ; Ren Qian[20] ; Ding Faming[21] ; Zhang Shenglin[21] ; Zhu Shaopin[21] ; Li Zhiping[21] ; Jie Ying[1,*1] ;
机构： [1]Beijing Institute of Ophthalmology, Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing Ophthalmology & Visual Sciences Key Laboratory, Beijing, China [2]Eye Center, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China [3]Department of Ophthalmology, Weifang Eye Hospital, Shandong, China [4]Department of Ophthalmology, Peking University Third Hospital, Beijing, China [5]Department of Ophthalmology, Bethune First Hospital of Jilin University, Changchun, China [6]Department of Ophthalmology, Tianjin Medical University Eye Hospital, Tianjin, China [7]Department of Ophthalmology, Tongji Hospital of Tongji University, Shanghai, China [8]Department of Ophthalmology, Beijing Hospital, Beijing, China [9]Department of Ophthalmology, Affiliated Hospital of Guizhou Medical University, Guiyang, China [10]Department of Ophthalmology, Union Hospital Tongji Medical College Huazhong University of Science and Technology, Hubei, China [11]Department of Ophthalmology, Nanjing First Hospital, Nanjing, China [12]Department of Ophthalmology, Zhujiang Hospital of Southern Medical University, Guangdong, China [13]Department of Corneal, Hebei Eye Hospital, Xing Tai, China [14]Department of Ophthalmology, Henan Eye Hospital, Henan Provincial People’s Hospital, Zhengzhou, China [15]Department of Ophthalmology, Wuhan Aier Eye Hospital Hankou Hospital, Hubei, China [16]Department of Ophthalmology, The First Affiliated Hospital of Harbin Medical University, Harbin, China [17]Department of Ophthalmology, Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China [18]Department of Ophthalmology, Eye Hospital of Shandong First Medical University, Shandong, China [19]Department of Ophthalmology, The Second Hospital of Anhui Medical University, Anhui, China [20]Department of Ophthalmology, Shijiazhuang People’s Hospital, Hebei, China [21]Jixing Pharmaceutical Co Ltd., Shanghai, China
出处：
DOI： 10.1016/j.lanwpc.2024.101032

关键词： Dry eye disease Nicotinic acetylcholine receptor agonist Varenicline nasal spray Randomized clinicaltrial Schirmer’s test score Eye dryness score

摘要：
Dry eye disease has a high prevalence and exerts a significant negative effect on quality of life. In China, there are currently no available nasal sprays to promote natural tear production in patients with dry eye disease. We therefore evaluated the efficacy and safety of OC-01 (varenicline solution) nasal spray versus vehicle in Chinese patients with dry eye disease.This was a randomized, multicenter, double-masked, vehicle-controlled, phase 3 clinical trial conducted at ophthalmology departments in 20 hospitals across China (NCT05378945). Eligible patients had a diagnosis of dry eye disease based on patient symptoms, Eye Dryness Score (EDS), Schirmer's Test (with topical anesthesia) Score (STS), and corneal fluorescein staining (CFS) score. Participants were randomly assigned 1:1 using an Interactive Web Response System (IWRS) to receive OC-01 0.6 mg/mL twice daily (BID) or vehicle nasal spray. Participants, investigators, and sponsor were all masked to treatment assignment. The primary endpoint was the percentage of subjects in the intention-to-treat population achieving ≥10 mm improvement in STS from baseline at week 4.In total, 340 patients were randomized from 21 July 2022 to 04 April 2023, 78.8% were female. Patients in the OC-01 group (n = 176) had significantly higher achievement of ≥10 mm improvement in STS (35.8% [n = 63] versus 17.7% [n = 29], stratified odds ratio: 2.67, 95% CI: 1.570-4.533, p = 0.0002) and a significantly greater increase from baseline STS (least-squares mean difference [SE]: 3.87 [0.794], p < 0.0001) at week 4 versus the vehicle group (n = 164). In addition, OC-01 led to a numerically greater reduction in mean EDS from baseline at week 4 compared to the vehicle group (LS mean [SE] difference: -1.3 [2.20]; 95% CI: -5.64 to 2.99, p = 0.5467). The most common adverse event was mild, transient sneezing (78% of OC-01 administrations). No serious adverse events related to nasal administration occurred.OC-01 (varenicline solution) nasal spray BID has clinically meaningful efficacy for reducing the signs (as measured by STS) and may improve the symptoms (as measured by EDS) of dry eye disease, with an excellent safety and tolerability profile, in the Chinese population.Jixing Pharmaceutical Co. Ltd.© 2024 The Author(s).

语种：
外文
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中科院(CAS)分区：
出版当年[2023]版：
大类 | 1 区 医学
小类 | 1 区 卫生保健与服务 1 区 公共卫生、环境卫生与职业卫生
最新[2023]版：
大类 | 1 区 医学
小类 | 1 区 卫生保健与服务 1 区 公共卫生、环境卫生与职业卫生
JCR分区：
出版当年[2022]版：
Q1 HEALTH CARE SCIENCES & SERVICES Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH
最新[2023]版：
Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Q1 HEALTH CARE SCIENCES & SERVICES

影响因子： 最新[2023版] 最新五年平均 出版当年[2022版] 出版当年五年平均 出版前一年[2021版] 出版后一年[2023版]

第一作者：
第一作者机构： [1]Beijing Institute of Ophthalmology, Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing Ophthalmology & Visual Sciences Key Laboratory, Beijing, China
通讯作者：
通讯机构： [1]Beijing Institute of Ophthalmology, Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing Ophthalmology & Visual Sciences Key Laboratory, Beijing, China [*1]Beijing Institute of Ophthalmology, Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University and Beijing Ophthalmology & Visual Sciences Key Laboratory, No. 1 Dongjiaominxiang St, Beijing, 100730, China.
推荐引用方式(GB/T 7714)：
Tian Lei,Jin Xiuming,Wang Jibing,et al.Varenicline solution nasal spray for dry eye disease in Chinese patients: a randomized phase 3 trial[J].LANCET REGIONAL HEALTH-WESTERN PACIFIC.2024,45:101032.doi:10.1016/j.lanwpc.2024.101032.
APA：
Tian Lei,Jin Xiuming,Wang Jibing,Xu Yonggen,Lu Chengwei...&Jie Ying.(2024).Varenicline solution nasal spray for dry eye disease in Chinese patients: a randomized phase 3 trial.LANCET REGIONAL HEALTH-WESTERN PACIFIC,45,
MLA：
Tian Lei,et al."Varenicline solution nasal spray for dry eye disease in Chinese patients: a randomized phase 3 trial".LANCET REGIONAL HEALTH-WESTERN PACIFIC 45.(2024):101032

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