Min-Ji Kang1,2, Youn-Hee Kim1, Miyoung Chou1, Jehyung Hwang3, Eun-Jeong Cheon1, Hyun-Jung Lee4, So-Hyang Chung1,2. 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. Catholic Institute for Visual Science, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. 3. Department of Ophthalmology, Sanggye Paik Hospital, Seoul, Korea. 4. Department of Biochemical Engineering, Seoil University, Seoul, Republic of Korea.
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-6and 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.
RCT Entities:
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.
Authors: Fabiola Atzeni; Francesco Gozza; Giacomo Cafaro; Carlo Perricone; Elena Bartoloni Journal: Front Immunol Date: 2022-05-06 Impact factor: 8.786