Evaluation of the Efficacy and Safety of A Novel 0.05% Cyclosporin A Topical Nanoemulsion in Primary Sjögren’s Syndrome Dry Eye

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.

Keywords:

• Cyclosporin A
• dry eyes
• nanoemulsion
• ocular surface staining scores
• primary Sjögren syndrome

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.

Additional information

Funding

This study was supported by the Korea Health Technology R&D Project, Ministry of Health & Welfare, Republic of Korea (HI13C0016) and by a grant from Taejoon Pharm; Korea Health Technology R&D Project, Ministry of Health & Welfare, Republic of Korea [HI13C0016].