ArticleThe Journal of international medical research2025
The effect of diquafosol on tear film inflammatory markers in patients with dry eye: A noncomparative, open-label, proof-of-concept study.
Article in The Journal of international medical research, 2025. 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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Abstract
ObjectiveTo analyze the effect of 3% diquafosol sodium ophthalmic solution on tear film proinflammatory cytokine levels, ocular symptoms, and tear film stability in patients with dry eye disease.MethodsThis was an open-label, noncomparative, single-cohort, interventional, proof-of-concept study among patients with dry eye disease who were administered diquafosol eye drops six times a day for 4 weeks. Pretreatment and posttreatment tear samples were collected, and ocular surface disease index scores and fluorescein tear break-up time were measured. Interferon-gamma, interleukin-1 beta, interleukin-6, and tumor necrosis factor-alpha levels were measured in the tear samples using a cytokine magnetic bead panel. Independent associations of cytokine responses with sex, age, tear break-up time, and ocular surface disease index were determined.ResultsThirty-one eyes (n = 31) in 31 patients with dry eye disease were included. At baseline, interleukin-6, tumor necrosis factor-alpha, and interferon-gamma were detected in all samples, whereas interleukin-1 beta was detected in 3% (1/31) of the samples. Baseline concentrations of interleukin-6, tumor necrosis factor-alpha, and interferon-gamma decreased by ≥25% in 58%, 51.6%, and 45.1% of the eyes, respectively, reaching significance for tumor necrosis factor-alpha (W = 101, z = 2.694, p = 0.006, two-tailed) and interleukin-6 (W = 134, z = 2.224, p = 0.026, two-tailed). The tear break-up time (from 3.95 to 4.65 s; p = 0.013) and ocular surface disease index scores (from 20.57 to 13.85; p = 0.005) significantly improved following treatment. Individual responses were found to be independent of age, sex, eye laterality, pretreatment tear break-up time, and ocular surface disease index scores based on the multivariate logistic regression.ConclusionDiquafosol reduced the levels of proinflammatory cytokines in the tears of patients with dry eye disease after 4 weeks of treatment, suggesting their possible role in modulating ocular surface inflammation. Larger prospective studies are recommended to validate these results.
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