Introduction The efficacy and safety of 3% diquafosol sodium eye drops in Chinese patients with dry eye in the real-world setting remains unclear. Methods 3099 patients with dry eye symptoms were screened according to Asia Dry Eye Society latest recommendation. Among them, 3000 patients were enrolled for a phase IV study. We followed up with multiple clinical characteristics including corneal fluorescein staining, tear break up time, Schirmer’s tests, visual acuity, intraocular pressure, and others. The follow ups were performed at baseline, 2 weeks and 4 weeks after treatment. Results Based on the results of corneal fluorescein staining and tear break up time, all age and gender subgroups exhibited obvious alleviation of the symptoms among the patients with dry eye, and the data in elderly group showed the most significant alleviation. All the adverse drug reactions (ADRs, 6.17%) were recorded, among which 6% local ocular ADRs were included. Meanwhile, mild ADRs (91.8%) accounted for the most. Most of the ADRs (89.75%) got a quick and full recovery, with an average time at 15.6 days. 1.37% of patients dropped out of the study due to ADRs. Discussion The use of 3% diquafosol sodium eye drop is effective and safe in the treatment of dry eye, with a low incidence of ADRs showing mild symptoms. This trial was registered at Chinese Clinical Trial Registry ID: ChiCTR1900021999 (Registration Date: 19/03/2019).
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Wenying Wang, Xiaonan Sun, Jiangyue Zhao et al.. 3% diquafosol sodium eye drops in Chinese patients with dry eye: a phase IV study. Frontiers in Medicine. (2023). https://doi.org/10.3389/fmed.2023.1089613 Wenying Wang, Xiaonan Sun, Jiangyue Zhao, Jilong Hao, Shaozhen Zhao, Xiaoming Yan, Ye Shen, Xiuming Jin, Yan Cheng, Linnong Wang, Jianjiang Xu, Peiquan Zhao, Hai Liu, Siming Zeng, Xu Wang, Weili Dong, Jinsong Xue, Wei Chen, Ping Guo, Li Li, Lijun Zhang, Dachuan Liu, Baihua Chen, Zhouqiao Lin, Yanjiang Fu, Lingyi Liang, Yanling Dong, Weizhong Yang, Yingping Deng, Guigang Li, Zhiqiang Pan
1Beijing Tongren Eye Center, Beijing Institute of Ophthalmology, Beijing Tongren Hospital, Capital Medical University and Beijing Ophthalmology and Visual Sciences Key Laboratory, Beijing, China 2Department of Ophthalmology, The 4th People's Hospital of Shenyang, Shenyang, China 3Department of Ophthalmology, The Forth Affiliated Hospital of Medical School, Shenyang, China 4Department of Ophthalmology, First Hospital of Jilin University, Jilin, China 5Department of Refractive and Corneal Diseases, Eye Center of Tianjin Medical University, Tianjin, China 6Department of Ophthalmology, Peking University First Hospital, Beijing, China 7Department of Ophthalmology, The First Affiliated Hospital of Medical School of Zhejiang University, Hangzhou, China 8Eye Center, The Second Affiliated Hospital of Medical School of Zhejiang University, Hangzhou, China 9Department of Ophthalmology, Xi'an No. 1 Hospital, Xi’an, China 10Department of Ophthalmology, Nanjing First Hospital, Nanjing, China 11Department of Ophthalmology, Eye and Ent Hospital of Fudan University, Shanghai, China 12Department of Ophthalmology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China 13Department of Ophthalmology, Second People's Hospital of Yunnan, Kunming, China 14Department of Ophthalmology, The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning City, China 15Department of Ocular Surface Diseases, Jinan Second People's Hospital, Jinan, China 16Department of Ophthalmology, Affiliated Hospital of Chengde Medical University, Chengde, China 17Department of Corneal Diseases, The Affiliated Hospital of Nanjing Medical University, Nanjing, China 18Department of Corneal Diseases, Eye Hospital, WMU, Zhejiang EYE Hospital, Hangzhou, China 19Department of Keratopathy and Ocular Surface Diseases, Shenzhen Eye Hospital, Shenzhen, China 20Department of Cataract Division, Joint Shantou International Eye Center (JSIEC), Shantou University and The Chinese University of Hong Kong, Shantou, China 21Department of Ophthalmology, The Third People's Hospital of Dalian, Dalian, China 22Department of Ophthalmology, Xuanwu Hospital of Capital Medical University, Beijing, China 23Department of Ophthalmology, The Second Hospital of Central South University, Changsha, China 24Department of Ophthalmology, The People's Hospital of Leqing, Wenzhou, China 25Department of Ophthalmology, Daqing Ophthalmologic Hospital, Daqing, China 26Department of Corneal Diseases, Zhongshan Ophthalmic Center (ZOC) of Sun YAT-Sen University, Guangzhou, China 27Department of Corneal Diseases, Qingdao Eye Hospital, Qingdao, China 28Department of Ophthalmology, Guangzhou First People's Hospital, Guangzhou, China 29Department of Ophthalmology, West China Hospital, Sichuan University, Chengdu, China 30Department of Ophthalmology, Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China 