Journal Article

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

Lee, Hyung Keun, Kim, Jae Yong, Kim, Tae-Im, Song, Jong Suk, Yoon, Kyung Chul, Kim, Eun Chul, Kim, Hyun Seung, Kim, Mee Kum, Kim, Hong Kyun, Chung, Tae-Young, Lee, Do Hyung, Choi, Chul Young, Park, Chang Hyun

2019

Overview

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). 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. 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. 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. KCT0002180 , retrospectively registered on 23 December 2016.

• Publisher: BioMed Central Ltd,Springer Nature B.V,BioMed Central,BMC
• Subject: Adult / Aged / Aged, 80 and over / Bioavailability / Clinical trials / Comparative analysis / Conjunctiva - pathology / Cornea / Cyclosporine / Cyclosporine - therapeutic use / Cyclosporins / Diquafosol / Drug therapy / Dry eye disease / Dry eye syndromes / Dry Eye Syndromes - drug therapy / Evidence-based medicine / Eye diseases / Female / Humans / Immunomodulators / Immunosuppressive Agents - therapeutic use / Lubricant Eye Drops - therapeutic use / Male / Middle Aged / Nanoemulsions / Ocular surface disease index / Older people / Ophthalmic agents / Ophthalmic Solutions - therapeutic use / Ophthalmology / Patient compliance / Patients / Pharmaceuticals / Polyphosphates - therapeutic use / Prescription drugs / Prospective Studies / Schirmer’s test / Statistical analysis / Tear break-up time / Tears - physiology / Uracil Nucleotides - therapeutic use / Young Adult