학술논문
3% diquafosol sodium eye drops in Chinese patients with dry eye: a phase IV study
Document Type
article
Author
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
Source
Frontiers in Medicine, Vol 10 (2023)
Subject
Language
English
ISSN
2296-858X
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).