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, Isabelle Jalbert, Mengliang Wu, Farshid Karimi, Ali Alghamdi, Laura E Downie, Fiona Stapleton

Abstract readClinical Trial Protocol

In one paragraph

Article in Annals of medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

7 authors.

Soumen SadhuSchool of Optometry and Vision Science, UNSW Sydney, Sydney, NSW, Australia.ORCID 0000-0002-1392-5972

Isabelle JalbertSchool of Optometry and Vision Science, UNSW Sydney, Sydney, NSW, Australia.ORCID 0000-0002-1351-0072

Mengliang WuDepartment of Optometry and Vision Sciences, The University of Melbourne, Parkville, Victoria, Australia.ORCID 0000-0002-0142-6623

Farshid KarimiSchool of Optometry and Vision Science, UNSW Sydney, Sydney, NSW, Australia.

Ali AlghamdiSchool of Optometry and Vision Science, UNSW Sydney, Sydney, NSW, Australia.

Laura E DownieDepartment of Optometry and Vision Sciences, The University of Melbourne, Parkville, Victoria, Australia.ORCID 0000-0002-1596-2259

Fiona StapletonSchool of Optometry and Vision Science, UNSW Sydney, Sydney, NSW, Australia.ORCID 0000-0002-7203-5443

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOcular 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.

methodsThis 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

conclusionThe 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.

Indexed as

Adaptive ImmunityCyclosporineDry Eye SyndromesImmunity, InnateImmunosuppressive AgentsAdministration, TopicalAdultConjunctivaCorneaCytokinesEpithelium, CornealFemaleHumansMaleMicroscopy, ConfocalMiddle AgedCyclosporineCytokinesImmunosuppressive AgentsOphthalmic Solutionsciclosporin ADry eye diseaseimpression cytologyin vivo confocal microscopyocular surface immune cells

Identifiers

PMID42762229

DOI10.1080/07853890.2026.2729947

PMCPMC13625527

What OpenQuestion holds

Textmetadata

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.