title: A randomised, parallel-group comparison study of diquafosol ophthalmic solution in patients with dry eye in China and Singapore.
abstract: OBJECTIVE
  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.
  
  
  BACKGROUND
  NCT01101984.
authors: Department of Ophthalmology, Eye & ENT Hospital of Fudan University, Shanghai, China.
authors: Lan
authors: L
authors: Gong
authors: Department of Ophthalmology, Eye & ENT Hospital of Fudan University, Shanghai, China.
authors: Xinghuai
authors: X
authors: Sun
authors: Department of Ophthalmology, Peking University Third Hospital, Beijing, China.
authors: Zhizhong
authors: Z
authors: Ma
authors: The School of Ophthalmology and Optometry Affiliated with Wenzhou Medical College, Wenzhou, Zhejiang, China.
authors: Qinmei
authors: Q
authors: Wang
authors: Department of Ophthalmology, Shanghai First People's Hospital, Shanghai, China.
authors: Xun
authors: X
authors: Xu
authors: Department of Ophthalmology, West China Medical School, West China Hospital, Sichuan University, Chengdu, China.
authors: Xiaoming
authors: X
authors: Chen
authors: Department of Ophthalmology, The Second Affiliated Hospital of Dalian Medical University, Dalian, China.
authors: Yan
authors: Y
authors: Shao
authors: Department of Ophthalmology, Second Affiliated Hospital Zhejiang University College of Medicine, Hangzhou, China.
authors: Ke
authors: K
authors: Yao
authors: Department of Ophthalmology, Second Xiangya Hospital, Central South University, Changsha, China.
authors: Luosheng
authors: L
authors: Tang
authors: Department of Ophthalmology, First Affiliated Hospital Zhejiang University College of Medicine, Hangzhou, China.
authors: Yangshun
authors: Y
authors: Gu
authors: Department of Ophthalmology, The 2nd Affiliated Hospital of Harbin Medical University, Harbin, China.
authors: Huiping
authors: H
authors: Yuan
authors: Parkway Eye Centre, Mount Elizabeth Hospital, Singapore, Singapore.
authors: Wei Han
authors: WH
authors: Chua
authors: Eagle Eye Centre, Mount Alvernia Hospital, Singapore, Singapore.
authors: Jacob Cheng Yen
authors: JC
authors: Chuan
authors: Singapore Eye Research Institute, Singapore National Eye Center, Duke-NUS Graduate Medical School, Singapore, Singapore.
authors: Louis
authors: L
authors: Tong
mesh_terms: D000368:Aged; D044466:Asian People / Q000208:ethnology*; D002681:China / Q000453:epidemiology; D015352:Dry Eye Syndromes / Q000175:diagnosis / Q000188:drug therapy* / Q000208:ethnology; D019793:Fluorescein; D005456:Fluorescent Dyes; D006801:Humans; D006820:Hyaluronic Acid / Q000627:therapeutic use; D008875:Middle Aged; D009883:Ophthalmic Solutions; D011122:Polyphosphates / Q000009:adverse effects / Q000627:therapeutic use*; D058912:Purinergic P2Y Receptor Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D012395:Rose Bengal; D012846:Singapore / Q000453:epidemiology; D013194:Staining and Labeling / Q000379:methods; D013666:Tears / Q000737:chemistry; D016896:Treatment Outcome; D014500:Uracil Nucleotides / Q000009:adverse effects / Q000627:therapeutic use*; D055675:Viscosupplements / Q000627:therapeutic use
chemical_list: D005456:Fluorescent Dyes; D009883:Ophthalmic Solutions; D011122:Polyphosphates; D058912:Purinergic P2Y Receptor Agonists; D014500:Uracil Nucleotides; D055675:Viscosupplements; D012395:Rose Bengal; C403315:diquafosol; D006820:Hyaluronic Acid; D019793:Fluorescein
keywords: Clinical Trial; Tears; Treatment Medical