| International FP-017 |
| Evaluation of the efficacy and safety of a novel 0.05% cyclosporin A topical nanoemulsion in primary Sjögren’s syndrome dry eye |
| Department of Ophthalmology, Sanggye Paik Hospital, College of Medicine, Inje University, Seoul, Republic of Korea(1)
Department of Ophthalmology and Visual Science, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea(2) |
| Min-Ji Kang(1), Jehyung Hwang(1), So-Hyang Chung(2) |
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Purpose : We sought to evaluate the efficacy and safety of a novel topical cyclosporin A 0.05% nanoemulsion (Cyporin N®; Taejoon Pharm, Seoul, Korea) in comparison with a cyclosporin A 0.05% conventional emulsion (Restasis®; Allergan Inc., Dublin, Ireland) in primary Sjögren’s syndrome (SS) dry eyes.
Methods : Primary SS dry eyes were randomly assigned into either a nanoemulsion group or a conventional emulsion group. Ocular surface staining scores including corneal and conjunctival staining scores, Schirmer I test results, tear film break-up time (TBUT), ocular surface disease index (OSDI) score, and a questionnaire about ocular discomfort were evaluated at baseline, four weeks, and 12 weeks. Conjunctival squamous metaplasia, goblet cell density, and interleukin (IL)-6 and matrix metalloproteinase 9 (MMP-9) gene expression from conjunctival impression cytology (CIC) were investigated at baseline and at 12 weeks.
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 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.
Conclusion : 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.
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