Lan Gong1, Xinghuai Sun1, Zhizhong Ma2, Qinmei Wang3, Xun Xu4, Xiaoming Chen5, Yan Shao6, Ke Yao7, Luosheng Tang8, Yangshun Gu9, Huiping Yuan10, Wei Han Chua11, Jacob Cheng Yen Chuan12, Louis Tong13. 1. Department of Ophthalmology, Eye & ENT Hospital of Fudan University, Shanghai, China. 2. Department of Ophthalmology, Peking University Third Hospital, Beijing, China. 3. The School of Ophthalmology and Optometry Affiliated with Wenzhou Medical College, Wenzhou, Zhejiang, China. 4. Department of Ophthalmology, Shanghai First People's Hospital, Shanghai, China. 5. Department of Ophthalmology, West China Medical School, West China Hospital, Sichuan University, Chengdu, China. 6. Department of Ophthalmology, The Second Affiliated Hospital of Dalian Medical University, Dalian, China. 7. Department of Ophthalmology, Second Affiliated Hospital Zhejiang University College of Medicine, Hangzhou, China. 8. Department of Ophthalmology, Second Xiangya Hospital, Central South University, Changsha, China. 9. Department of Ophthalmology, First Affiliated Hospital Zhejiang University College of Medicine, Hangzhou, China. 10. Department of Ophthalmology, The 2nd Affiliated Hospital of Harbin Medical University, Harbin, China. 11. Parkway Eye Centre, Mount Elizabeth Hospital, Singapore, Singapore. 12. Eagle Eye Centre, Mount Alvernia Hospital, Singapore, Singapore. 13. Singapore Eye Research Institute, Singapore National Eye Center, Duke-NUS Graduate Medical School, Singapore, Singapore.
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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
RCT Entities:
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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Entities:
Keywords:
Clinical Trial; Tears; Treatment Medical
Authors: Louis Tong; Li Lim; Donald Tan; Wee Jin Heng; Jimmy Lim; Cordelia Chan; Anshu Arundhati; Anna Tan Journal: Asia Pac J Ophthalmol (Phila) Date: 2021-11-11