PT  - JOURNAL ARTICLE
AU  - Lan Gong
AU  - Xinghuai Sun
AU  - Zhizhong Ma
AU  - Qinmei Wang
AU  - Xun Xu
AU  - Xiaoming Chen
AU  - Yan Shao
AU  - Ke Yao
AU  - Luosheng Tang
AU  - Yangshun Gu
AU  - Huiping Yuan
AU  - Wei Han Chua
AU  - Jacob Cheng Yen Chuan
AU  - Louis Tong
TI  - A randomised, parallel-group comparison study of diquafosol ophthalmic solution in patients with dry eye in China and Singapore
AID  - 10.1136/bjophthalmol-2014-306084
DP  - 2015 Jul 01
TA  - British Journal of Ophthalmology
PG  - 903--908
VI  - 99
IP  - 7
4099  - http://bjo.bmj.com/content/99/7/903.short
4100  - http://bjo.bmj.com/content/99/7/903.full
SO  - Br J Ophthalmol2015 Jul 01; 99
AB  - 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.