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Table · dataset · 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

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<p>Ocular surface immune cells and pro-inflammatory cytokines have been reported to be increased in Dry eye disease (DED).

Description

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.

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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>

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Inferred from text
Disease 75% · Imaging 75% · Microscopy 75%
Provenance · 1 source records, 22 field assertions
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