Observational study evaluates a point-of-care tear test for diagnosing dry eye disease, predicting responsiveness to therapy, highlighting potential for personalized management.
METHODS: A single center, observational, longitudinal clinical study enrolled 593 participants graded by TFOS DEWS II criteria: 495 DED (including 83 with severe MGD), and 98 healthy controls. Tear fluid was collected using a microfluidic tear collection device and analyzed for five biomarkers (lactoferrin, human serum albumin, lysozyme, mucin and IgA) by lateral-flow immunochromatographic assay (LFIA). Optimal logistic regression models were selected for differentiating DED vs. healthy, severe vs. non-severe DED, severe MGD vs. non-MGD in DED patients, and prediction (at baseline) of CysA responsiveness. RESULTS: predicted CysA responsiveness with 93.8% sensitivity, 63.1% specificity, AUC = 0.86, and NPV = 92.3%. CONCLUSIONS: may potentially offer the means for rapid, noninvasive tear biomarker profiling within 10 minutes, providing accurate diagnosis of DED, severity stratification, detection of severe MGD, and prediction of therapeutic response to CysA. These results support its role as a personalized diagnostic platform for optimizing management of DED.
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Basu et al. (2026) studied this question.
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