| Summary: | Dry eye is considered an inflammatory disease. Gut microbiota are important in the regulation of low-grade chronic inflammation, including in the eye. Probiotics and prebiotics are increasingly used to regulate chronic-disease-associated gut dysbiosis. Therefore, this double-masked, randomized controlled clinical trial aimed to explore the potential of oral probiotics and prebiotics in the management of dry eye disease. In total, 41 participants with dry eye received probiotic and prebiotic supplements (treatment group, <i>n</i> = 23) or respective placebos (control group, <i>n</i> = 18) for 4 months. Dry eye symptoms and signs were evaluated using the Ocular Surface Disease Index (OSDI), Dry Eye Questionnaire 5, osmolarity, non-invasive keratograph break-up time (NIKBUT), ocular surface staining, tear meniscus height (TMH), lipid layer thickness, and conjunctival redness. After 4 months, the average OSDI score of the treatment group was significantly better compared to that of the controls (16.8 ± 5.9 vs. 23.4 ± 7.4; <i>p</i> < 0.001). The NIKBUT and TMH did not change significantly with treatment (<i>p</i> = 0.31 and <i>p</i> = 0.84) but reduced significantly for controls on average by −5.5 ± 1.0 secs (<i>p</i> = 0.03) and 0.2 ± 0.1 mm (<i>p</i> = 0.02). These data suggest that probiotics and prebiotics might be effective in the management of dry eye disease.
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