Purpose: To evaluate TeaRx™, a 10-minute, multi-parametric tear test, as a single point-of-care diagnostic device for assessment of dry eye disease (DED), stratifying severity, identifying severe meibomian gland dysfunction (MGD), and predicting patient response to topical cyclosporine A (CysA) therapy.
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: Based on the models selected, TeaRx™ differentiated DED (at all severity levels) from healthy controls with 71.5% sensitivity, 63.1% specificity, and AUC = 0.72. Severe DED was differentiated from non-severe DED with 80.6% sensitivity, 66.7% specificity, AUC = 0.77. Severe MGD within DED was identified with 80.6% sensitivity, 61.3% specificity, AUC = 0.80. TeaRx™ predicted CysA responsiveness with 93.8% sensitivity, 63.1% specificity, AUC = 0.86, and NPV = 92.3%.
Conclusions: Based on the results of the current study, TeaRx™ 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.
Keywords: Dry eye disease; cyclosporine; point of care diagnostics; tear film.