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A randomised, parallel-group comparison study of diquafosol ophthalmic solution in patients with dry eye in China and Singapore
  1. Lan Gong1,
  2. Xinghuai Sun1,
  3. Zhizhong Ma2,
  4. Qinmei Wang3,
  5. Xun Xu4,
  6. Xiaoming Chen5,
  7. Yan Shao6,
  8. Ke Yao7,
  9. Luosheng Tang8,
  10. Yangshun Gu9,
  11. Huiping Yuan10,
  12. Wei Han Chua11,
  13. Jacob Cheng Yen Chuan12,
  14. Louis Tong13
  1. 1Department of Ophthalmology, Eye & ENT Hospital of Fudan University, Shanghai, China
  2. 2Department of Ophthalmology, Peking University Third Hospital, Beijing, China
  3. 3The School of Ophthalmology and Optometry Affiliated with Wenzhou Medical College, Wenzhou, Zhejiang, China
  4. 4Department of Ophthalmology, Shanghai First People's Hospital, Shanghai, China
  5. 5Department of Ophthalmology, West China Medical School, West China Hospital, Sichuan University, Chengdu, China
  6. 6Department of Ophthalmology, The Second Affiliated Hospital of Dalian Medical University, Dalian, China
  7. 7Department of Ophthalmology, Second Affiliated Hospital Zhejiang University College of Medicine, Hangzhou, China
  8. 8Department of Ophthalmology, Second Xiangya Hospital, Central South University, Changsha, China
  9. 9Department of Ophthalmology, First Affiliated Hospital Zhejiang University College of Medicine, Hangzhou, China
  10. 10Department of Ophthalmology, The 2nd Affiliated Hospital of Harbin Medical University, Harbin, China
  11. 11Parkway Eye Centre, Mount Elizabeth Hospital, Singapore, Singapore
  12. 12Eagle Eye Centre, Mount Alvernia Hospital, Singapore, Singapore
  13. 13Singapore Eye Research Institute, Singapore National Eye Center, Duke-NUS Graduate Medical School, Singapore, Singapore
  1. Correspondence to Dr Xinghuai Sun, Department of Ophthalmology, Eye & ENT Hospital of Fudan University, 83 Fenyang Road, Shanghai, 200031, China; xhsun{at}shmu.edu.cn

Abstract

Aims To compare the efficacy and safety of 3% diquafosol ophthalmic solution with those of 0.1% sodium hyaluronate ophthalmic solution in patients with dry eye in China and Singapore.

Methods A total of 497 patients with dry eye (Schirmer's test, 5 mm; fluorescein and RB score, 3 points) from China and Singapore were randomised to receive either diquafosol ophthalmic solution (diquafosol) or sodium hyaluronate ophthalmic solution (HA) at 1:1 ratio. The fluorescein staining scores and rose bengal (RB) subjective symptom scores and tear film breakup time were evaluated before treatment and 2 and 4 weeks after start of treatment.

Results In the diquafosol group, changes in fluorescein and RB scores compared with baseline at week 4 or at the time of discontinuation were −2.1±1.5 and −2.5±2.0, respectively. Compared with the HA group, changes in fluorescein score were non-inferior and changes in RB score were superior (p=0.019). In addition, diquafosol and HA improved tear film breakup time by 1.046±1.797 and 0.832±1.775 s, respectively (no significant intergroup difference). Adverse event onset rates were 16.3% (40 of 246 subjects) and 10.0% (25 of 251 subjects) in the diquafosol group and HA group, respectively, with borderline significant intergroup differences (p=0.046), while adverse drug reaction incidence rates were 12.2% (30 of 246 subjects) and 6.0% (15 of 251 subjects), respectively (p=0.019). Only mild adverse drug reactions (>2%) in the form of eye discharge, itching or irritation were observed.

Conclusions Diquafosol improved fluorescein staining score in a manner similar to HA, and significantly improved RB score compared with HA.

Trial registration number NCT01101984.

  • Tears
  • Treatment Medical
  • Clinical Trial

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