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Randomized Controlled Trial
. 2019 Jun 17;19(1):131.
doi: 10.1186/s12886-019-1136-8.

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

Chang Hyun Park  1 , Hyung Keun Lee  2 , Mee Kum Kim  3 , Eun Chul Kim  4 , Jae Yong Kim  5 , Tae-Im Kim  6 , Hong Kyun Kim  7 , Jong Suk Song  8 , Kyung Chul Yoon  9 , Do Hyung Lee  10 , Tae-Young Chung  11 , Chul Young Choi  12 , Hyun Seung Kim  13
Affiliations
Randomized Controlled Trial

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

Chang Hyun Park et al. BMC Ophthalmol. .

Retraction in

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.

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

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Schematic illustration of the study design and patient selection. Safety set: the patients who received the assigned treatment at least once; FAS: full analysis set, the patients who provided data for evaluating the primary efficacy; PPS: per protocol set, the patients who completed the treatment without violation; CN: 0.05% cyclosporine nanoemulsion; DQ: 3% diquafosol
Fig. 2
Fig. 2
Instillation adherence. Patients in both groups were asked to instill drops 6 times per day: 2 times with cyclosporine plus 4 times with hyaluronic acid in the 0.05% cyclosporine group (CN), and 6 times with diquafosol in the 3% diquafosol group (DQ). All patients in both groups were allowed to instill hyaluronic acid ad libitum when they felt discomfort and they were told the total daily number of instillations should not exceed six per day as possible
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