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

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Authors
Park, Chang Hyun; Lee, Hyung Keun; Kim, Mee Kum; Kim, Eun Chul; Kim, Jae Yong; Kim, Tae-im; Kim, Hong Kyun; Song, Jong Suk; Yoon, Kyung Chul; Lee, Do Hyung; Chung, Tae-Young; Choi, Chul Young; Kim, Hyun Seung
Issue Date
2019-06-17
Publisher
BioMed Central
Citation
BMC Ophthalmology. 19(1):131
Keywords
Dry eye diseaseCyclosporineDiquafosolTear break-up timeSchirmer’s testOcular surface disease index
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.
ISSN
1471-2415
Language
English
URI
http://hdl.handle.net/10371/156087
DOI
https://doi.org/10.1186/s12886-019-1136-8
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College of Medicine/School of Medicine (의과대학/대학원)Ophthalmology (안과학전공)Journal Papers (저널논문_안과학전공)
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