A randomised, parallel-group comparison study of diquafosol ophthalmic solution in patients with dry eye in China and Singapore

• Published in: British journal of ophthalmology Vol. 99; no. 7; pp. 903 - 908
• Main Authors: Gong, Lan, Sun, Xinghuai, Ma, Zhizhong, Wang, Qinmei, Xu, Xun, Chen, Xiaoming, Shao, Yan, Yao, Ke, Tang, Luosheng, Gu, Yangshun, Yuan, Huiping, Chua, Wei Han, Chuan, Jacob Cheng Yen, Tong, Louis
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 01.07.2015
• Subjects: Aged; Asian Continental Ancestry Group - ethnology; China - epidemiology; Dry Eye Syndromes - diagnosis; Dry Eye Syndromes - drug therapy; Dry Eye Syndromes - ethnology; Eye care products; FDA approval; Fluorescein; Fluorescent Dyes; Glaucoma; Hospitals; Humans; Hyaluronic Acid - therapeutic use; Laboratories; Middle Aged; Ophthalmic Solutions; Ophthalmology; Polyphosphates - adverse effects; Polyphosphates - therapeutic use; Purinergic P2Y Receptor Agonists - adverse effects; Purinergic P2Y Receptor Agonists - therapeutic use; Rose Bengal; Singapore - epidemiology; Staining and Labeling - methods; Tears - chemistry; Treatment Outcome; University colleges; Uracil Nucleotides - adverse effects; Uracil Nucleotides - therapeutic use; Viscosupplements - therapeutic use; China; Singapore; Clinical Trial; Treatment Medical; Tears
• ISSN: 0007-1161; 1468-2079; 1468-2079
• DOI: 10.1136/bjophthalmol-2014-306084

AimsTo 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.MethodsA 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.ResultsIn 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.ConclusionsDiquafosol improved fluorescein staining score in a manner similar to HA, and significantly improved RB score compared with HA.Trial registration numberNCT01101984.