2026-10-12T19:04:36Z https://api.figshare.com/v2/oai

oai:figshare.com:article/33942786 2026-09-19T14:48:06Z category_146 category_7 category_8 category_16 category_46 category_734 category_61 category_135 portal_87 item_type_3 month_year_09_2026

The effect of 0.1% topical ciclosporin a for 12-weeks on the ocular surface innate and adaptive immune response in dry eye disease: protocol for a randomized controlled clinical trial Soumen Sadhu (25076244) Isabelle Jalbert (7356386) Mengliang Wu (6438347) Farshid Karimi (25076247) Ali Alghamdi (25076250) Laura E. Downie (2207467) Fiona Stapleton (3712732) Space Science Medicine Microbiology Physiology Immunology Biological Sciences not elsewhere classified Developmental Biology Computational Biology Dry eye disease ciclosporin A ocular surface immune cells in vivo confocal microscopy impression cytology <p>Ocular surface immune cells and pro-inflammatory cytokines have been reported to be increased in Dry eye disease (DED). Immunosuppressive agents such as topical cyclosporine A (CsA) can inhibit dendritic cell and T cell activation. However, CsA’s impact on ocular surface immune responses and tear cytokines has not been systematically studied. This paper describes a clinical trial protocol to investigate the effects of 0.1% CsA plus mineral oil eye drops, versus mineral oil eye drops alone on the ocular surface immune response in DED.</p> <p>This two-arm examiner-masked randomized controlled trial will enrol 60 eligible participants with moderate-to-severe DED. Participants will be randomized (1:1) either into the CsA plus mineral oil eye drops or mineral oil eye drops alone group and evaluated at baseline, 4-weeks and 12-weeks. Corneal immune cells will be assessed using static <i>in vivo</i> confocal microscopy (IVCM) for total corneal epithelial immune cells and with a novel technique, functional-IVCM (Fun-IVCM), to differentiate corneal epithelial immune cell subsets (i.e. putative T cells from dendritic cells). Conjunctival immune cells will be phenotyped using impression cytology and flow cytometry (CD45, CD3, CD4, CD8, CD11c, HLA-DR). Tear cytokine analyses will be conducted for IL-2, IL-4, IL-6, IL-12, IL-17, IL-23, IFN- γ using a multiplex bead assay.</p> <p>The clinical trial combines ocular intravital imaging, immune cell phenotyping and cytokine analysis to advance knowledge on the application of CsA in moderate-to-severe DED. It may also establish new immune cell parameters as biomarkers for monitoring the efficacy of anti-inflammatory DED treatments. <i>Trial registration:</i> ClinicalTrials.gov, NCT06898853.</p> 2026-09-19T14:48:06Z Dataset Dataset 10.6084/m9.figshare.33942786.v1 https://figshare.com/articles/dataset/The_effect_of_0_1_topical_ciclosporin_a_for_12-weeks_on_the_ocular_surface_innate_and_adaptive_immune_response_in_dry_eye_disease_protocol_for_a_randomized_controlled_clinical_trial/33942786 CC BY 4.0