ABSTRACT
Purpose: To evaluate the efficacy and safety of a novel topical cyclosporin A 0.05% nanoemulsion in comparison with a conventional emulsion in primary Sjögren’s syndrome dry eyes.
Methods: Prospective, randomized, double-blinded study was conducted.
Results: Corneal and conjunctival staining score was improved in both groups, with a faster change noted in the nanoemulsion group at 12 weeks (p < 0.05). Tear film break-up time was significantly improved in the nanoemulsion group at 12 weeks (p < 0.05), while ocular surface disease index score was improved in both groups without a difference at 12 weeks. Schirmer I value and goblet cell grade did not change in both groups. IL-6 and MMP-9 were significantly decreased in both groups at 12 weeks.
Conclusions: Both nanoemulsion and conventional cyclosporin A improved ocular signs, symptoms, and conjunctival inflammation. However, the novel cyclosporin A nanoemulsion showed faster improvement of ocular surface staining scores than the conventional emulsion.
Author contributions
Study concept and design (MJK, SHC); data collection (MJK, YHK, MC, JH, EJC, HJL, SHC); analysis and interpretation of data (MJK, HJL, SHC); writing the manuscript (MJK, SHC); critical revision of the manuscript (MJK, HJL, SHC); statistical expertise (MJK, SHC); administrative, technical, or material support (MJK, SHC); supervision (SHC)
Conflict of interest
The authors declare no conflict of interest. The authors alone are responsible for the content and writing of the paper.