The increase of aqueous tear volume by diquafosol sodium in dry-eye patients with Sjögren’s syndrome: a pilot study

et al. 2019

Preprint

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 227 eyes from 227 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 reduced from the baseline by -6.60 for CN and -6.63 for DQ group (P=0.9739 between groups). TBUT and Schirmer values for CN were significantly improved from the baseline at 4 and 12 weeks (P< 0.0001). However, for DQ, TBUT showed significant improvement at week 12 only (P=0.0281). Mean OSDI score differences from the baseline to 12 weeks were -13.03±19.63 in CN and -16.11±20.87 in DQ, respectively (P=0.854 between groups). Regarding drug compliance, the mean instillation frequency of CN was lesser than that of DQ (P<0.001). 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, Registered 23 December 2016 (retrospectively registered)

Section: Discussionmentioning

confidence: 99%

WITHDRAWN: Comparison of 0.05% cyclosporine and 3% diquafosol solution for dry eye patients: A randomized, blinded, multicenter clinical trial

et al. 2019

Preprint

“…Kim et al reported that a cyclosporine treatment group also used artificial tears to reduce symptoms of Meibomian gland dysfunction [23]. Diquafosol treatment groups also used artificial tears to inhibit DED symptoms [11,13,23,24]. In short, neither cyclosporine nor diquafosol were solely adequate for the treatment of moderate or severe DED.…”

Section: Discussionmentioning

confidence: 99%

WITHDRAWN: Comparison of 0.05% cyclosporine and 3% diquafosol solution for dry eye patients: A randomized, blinded, multicenter clinical trial

et al. 2019

Preprint

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.

Section: Discussionmentioning

confidence: 99%

WITHDRAWN: Comparison of 0.05% cyclosporine and 3% diquafosol solution for dry eye patients: A randomized, blinded, multicenter clinical trial

et al. 2019

Preprint

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.