Abstract
BackgroundThis 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).MethodsThis 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.ResultsAt 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.ConclusionsThe 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 registrationKCT0002180, retrospectively registered on 23 December 2016.
Highlights
This study is aim to compare the clinical effectiveness between the two most prominent dry eyeR disease (DED)-specific eye drops, 0.05% cyclosporine (CN) and 3% diquafosol (DQ)
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
Study population Adult patients were eligible for participation if they had been diagnosed with moderate dry eyeR disease (DED) according to the following criteria: (1) symptomatic dry eye with complaint of ocular dryness, (2) cornea fluorescein staining ≥4 on the National Eye Institute (NEI) scale, and (3) tear break-up time (TBUT) ≤ 10 s
Summary
This study is aim to compare the clinical effectiveness between the two most prominent dry eye. R disease (DED)-specific eye drops, 0.05% cyclosporine (CN) and 3% diquafosol (DQ). With the increase in the elderly population, dry eye dis- Current Research Information System (CRIS) Ease (DED) is the most common eye disease [1]. The trial registration number is ous clinical evidences cumulate, the awareness of DED KCT0002180. Despite hundreds of treatment regimens, DED persists as a common concern
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