Comparison of 0.05% cyclosporine and 3% diquafosol solution for dry eye patients: a randomized, blinded, multicenter clinical trial

BMC Ophthalmology

Jae Yong Kim¹  Eun Chul Kim²  Kyung Chul Yoon³  Do Hyung Lee⁴  Chul Young Choi⁵  Jong Suk Song⁶  Hong Kyun Kim⁷  Tae-Young Chung⁸  Mee Kum Kim⁹  Chang Hyun Park^1,10  Hyun Seung Kim^1,10  Hyung Keun Lee^1,11  Tae-im Kim^1,12 

[1] Department of Ophthalmology, Asan Medical Center, University of Ulsan College of Medicine;Department of Ophthalmology, Bucheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea;Department of Ophthalmology, Chonnam National University Medical School;Department of Ophthalmology, Ilsan Paik Hospital, Inje University College of Medicine;Department of Ophthalmology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine;Department of Ophthalmology, Korea University College of Medicine;Department of Ophthalmology, Kyungpook National University School of Medicine;Department of Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine;Department of Ophthalmology, Seoul National University Hospital, Seoul National University College of Medicine;Department of Ophthalmology, Yeouido St. Mary’s Hospital, College of Medicine, The Catholic University of Korea;The Institute of Vision Research, Department of Ophthalmology, Gangnam Severance Hospital, Yonsei University College of Medicine;The Institute of Vision Research, Department of Ophthalmology, Severance Hospital, Yonsei University College of Medicine;

关键词: Dry eye disease;    Cyclosporine;    Diquafosol;    Tear break-up time;    Schirmer’s test;    Ocular surface disease index;   

DOI  :  10.1186/s12886-019-1136-8

来源: DOAJ

【 摘 要 】

Abstract Background This study is aim to compare the clinical effectiveness between the two most prominent dry eye disease (DED)-specific eye drops, 0.05% cyclosporine (CN) and 3% diquafosol (DQ). Methods This is a multi-centered, randomized, masked, prospective clinical study. A total of 153 DED patients were randomly allocated to use CN twice per day or DQ six times daily. Cornea and conjunctival staining scores (NEI scale), tear break-up time (TBUT), Schirmer test scores, and ocular surface disease index (OSDI) score were measured at baseline, 4 and 12 weeks after treatment. Results At 12 weeks after treatment, NEI scaled scores were significantly reduced from the baseline by − 6.60 for CN and − 6.63 for DQ group (all P < 0.0001, P = 0.9739 between groups). TBUT and Schirmer values for CN were significantly improved from the baseline at 4 and 12 weeks (P = 0.0034, P < 0.0001 for TBUT, P = 0.0418, P = 0.0031 for Schirmer test). However, for DQ, TBUT showed significant improvement at 12 weeks only (P = 0.0281). Mean OSDI score differences from the baseline to 12 weeks were improved by − 13.03 ± 19.63 for CN and − 16.11 ± 20.87 for DQ, respectively (all P < 0.0001, P = 0.854 between groups). Regarding drug compliance, the mean instillation frequency of CN was less than that of DQ (P < 0.001). There were no statistically significant intergroup differences in safety evaluation. Conclusions The level of improvement regarding NEI, TBUT, and OSDI scores were not significantly different between the two treatment groups. However, with regards to the early improvement of TBUT and patient compliance, patients using CN improved faster and with greater adherence to drug usage than did those treated with DQ. Trial registration KCT0002180, retrospectively registered on 23 December 2016.

【 授权许可】

Unknown