Frontiers in Medicine (May 2023)
3% diquafosol sodium eye drops in Chinese patients with dry eye: a phase IV study
- 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
Affiliations
- Wenying Wang
- Beijing Tongren Eye Center, Beijing Institute of Ophthalmology, Beijing Tongren Hospital, Capital Medical University and Beijing Ophthalmology and Visual Sciences Key Laboratory, Beijing, China
- Xiaonan Sun
- Department of Ophthalmology, The 4th People's Hospital of Shenyang, Shenyang, China
- Jiangyue Zhao
- Department of Ophthalmology, The Forth Affiliated Hospital of Medical School, Shenyang, China
- Jilong Hao
- Department of Ophthalmology, First Hospital of Jilin University, Jilin, China
- Shaozhen Zhao
- Department of Refractive and Corneal Diseases, Eye Center of Tianjin Medical University, Tianjin, China
- Xiaoming Yan
- Department of Ophthalmology, Peking University First Hospital, Beijing, China
- Ye Shen
- Department of Ophthalmology, The First Affiliated Hospital of Medical School of Zhejiang University, Hangzhou, China
- Xiuming Jin
- Eye Center, The Second Affiliated Hospital of Medical School of Zhejiang University, Hangzhou, China
- Yan Cheng
- Department of Ophthalmology, Xi'an No. 1 Hospital, Xi’an, China
- Linnong Wang
- 0Department of Ophthalmology, Nanjing First Hospital, Nanjing, China
- Jianjiang Xu
- 1Department of Ophthalmology, Eye and Ent Hospital of Fudan University, Shanghai, China
- Peiquan Zhao
- 2Department of Ophthalmology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
- Hai Liu
- 3Department of Ophthalmology, Second People's Hospital of Yunnan, Kunming, China
- Siming Zeng
- 4Department of Ophthalmology, The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning City, China
- Xu Wang
- 5Department of Ocular Surface Diseases, Jinan Second People's Hospital, Jinan, China
- Weili Dong
- 6Department of Ophthalmology, Affiliated Hospital of Chengde Medical University, Chengde, China
- Jinsong Xue
- 7Department of Corneal Diseases, The Affiliated Hospital of Nanjing Medical University, Nanjing, China
- Wei Chen
- 8Department of Corneal Diseases, Eye Hospital, WMU, Zhejiang EYE Hospital, Hangzhou, China
- Ping Guo
- 9Department of Keratopathy and Ocular Surface Diseases, Shenzhen Eye Hospital, Shenzhen, China
- Li Li
- 0Department of Cataract Division, Joint Shantou International Eye Center (JSIEC), Shantou University and The Chinese University of Hong Kong, Shantou, China
- Lijun Zhang
- 1Department of Ophthalmology, The Third People's Hospital of Dalian, Dalian, China
- Dachuan Liu
- 2Department of Ophthalmology, Xuanwu Hospital of Capital Medical University, Beijing, China
- Baihua Chen
- 3Department of Ophthalmology, The Second Hospital of Central South University, Changsha, China
- Zhouqiao Lin
- 4Department of Ophthalmology, The People's Hospital of Leqing, Wenzhou, China
- Yanjiang Fu
- 5Department of Ophthalmology, Daqing Ophthalmologic Hospital, Daqing, China
- Lingyi Liang
- 6Department of Corneal Diseases, Zhongshan Ophthalmic Center (ZOC) of Sun YAT-Sen University, Guangzhou, China
- Yanling Dong
- 7Department of Corneal Diseases, Qingdao Eye Hospital, Qingdao, China
- Weizhong Yang
- 8Department of Ophthalmology, Guangzhou First People's Hospital, Guangzhou, China
- Yingping Deng
- 9Department of Ophthalmology, West China Hospital, Sichuan University, Chengdu, China
- Guigang Li
- 0Department of Ophthalmology, Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
- Zhiqiang Pan
- Beijing Tongren Eye Center, Beijing Institute of Ophthalmology, Beijing Tongren Hospital, Capital Medical University and Beijing Ophthalmology and Visual Sciences Key Laboratory, Beijing, China
- DOI
- https://doi.org/10.3389/fmed.2023.1089613
- Journal volume & issue
-
Vol. 10
Abstract
IntroductionThe efficacy and safety of 3% diquafosol sodium eye drops in Chinese patients with dry eye in the real-world setting remains unclear.Methods3099 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.ResultsBased 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.DiscussionThe 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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