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

doi:10.3389/fmed.2023.1089613

3% diquafosol sodium eye drops in Chinese patients with dry eye: a phase IV study

Front Med (Lausanne). 2023 May 25:10:1089613. doi: 10.3389/fmed.2023.1089613. eCollection 2023.

Authors

Wenying Wang¹, Xiaonan Sun², Jiangyue Zhao³, Jilong Hao⁴, Shaozhen Zhao⁵, Xiaoming Yan⁶, Ye Shen⁷, Xiuming Jin⁸, Yan Cheng⁹, Linnong Wang¹⁰, Jianjiang Xu¹¹, Peiquan Zhao¹², Hai Liu¹³, Siming Zeng¹⁴, Xu Wang¹⁵, Weili Dong¹⁶, Jinsong Xue¹⁷, Wei Chen¹⁸, Ping Guo¹⁹, Li Li²⁰, Lijun Zhang²¹, Dachuan Liu²², Baihua Chen²³, Zhouqiao Lin²⁴, Yanjiang Fu²⁵, Lingyi Liang²⁶, Yanling Dong²⁷, Weizhong Yang²⁸, Yingping Deng²⁹, Guigang Li³⁰, Zhiqiang Pan¹

Affiliations

¹ Beijing Tongren Eye Center, Beijing Institute of Ophthalmology, Beijing Tongren Hospital, Capital Medical University and Beijing Ophthalmology and Visual Sciences Key Laboratory, Beijing, China.
² Department of Ophthalmology, The 4th People's Hospital of Shenyang, Shenyang, China.
³ Department of Ophthalmology, The Forth Affiliated Hospital of Medical School, Shenyang, China.
⁴ Department of Ophthalmology, First Hospital of Jilin University, Jilin, China.
⁵ Department of Refractive and Corneal Diseases, Eye Center of Tianjin Medical University, Tianjin, China.
⁶ Department of Ophthalmology, Peking University First Hospital, Beijing, China.
⁷ Department of Ophthalmology, The First Affiliated Hospital of Medical School of Zhejiang University, Hangzhou, China.
⁸ Eye Center, The Second Affiliated Hospital of Medical School of Zhejiang University, Hangzhou, China.
⁹ Department of Ophthalmology, Xi'an No. 1 Hospital, Xi'an, China.
¹⁰ Department of Ophthalmology, Nanjing First Hospital, Nanjing, China.
¹¹ Department of Ophthalmology, Eye and Ent Hospital of Fudan University, Shanghai, China.
¹² Department of Ophthalmology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China.
¹³ Department of Ophthalmology, Second People's Hospital of Yunnan, Kunming, China.
¹⁴ Department of Ophthalmology, The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning City, China.
¹⁵ Department of Ocular Surface Diseases, Jinan Second People's Hospital, Jinan, China.
¹⁶ Department of Ophthalmology, Affiliated Hospital of Chengde Medical University, Chengde, China.
¹⁷ Department of Corneal Diseases, The Affiliated Hospital of Nanjing Medical University, Nanjing, China.
¹⁸ Department of Corneal Diseases, Eye Hospital, WMU, Zhejiang EYE Hospital, Hangzhou, China.
¹⁹ Department of Keratopathy and Ocular Surface Diseases, Shenzhen Eye Hospital, Shenzhen, China.
²⁰ Department of Cataract Division, Joint Shantou International Eye Center (JSIEC), Shantou University and The Chinese University of Hong Kong, Shantou, China.
²¹ Department of Ophthalmology, The Third People's Hospital of Dalian, Dalian, China.
²² Department of Ophthalmology, Xuanwu Hospital of Capital Medical University, Beijing, China.
²³ Department of Ophthalmology, The Second Hospital of Central South University, Changsha, China.
²⁴ Department of Ophthalmology, The People's Hospital of Leqing, Wenzhou, China.
²⁵ Department of Ophthalmology, Daqing Ophthalmologic Hospital, Daqing, China.
²⁶ Department of Corneal Diseases, Zhongshan Ophthalmic Center (ZOC) of Sun YAT-Sen University, Guangzhou, China.
²⁷ Department of Corneal Diseases, Qingdao Eye Hospital, Qingdao, China.
²⁸ Department of Ophthalmology, Guangzhou First People's Hospital, Guangzhou, China.
²⁹ Department of Ophthalmology, West China Hospital, Sichuan University, Chengdu, China.
³⁰ Department of Ophthalmology, Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.

Abstract

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).

Keywords: diquafosol sodium eye drops; dry eye; efficacy; flourescein staining; safety.

Copyright © 2023 Wang W, Sun X, Zhao J, Hao J, Zhao S, Yan X, Shen Y, Jin X, Cheng Y, Wang L, Xu J, Zhao P, Liu H, Zeng S, Wang X, Dong W, Xue J, Chen W, Guo P, Li L, Zhang L, Liu D, Chen B, Lin Z, Fu Y, Liang L, Dong Y, Yang W, Deng Y, Li G and Pan Z.