INTRODUCTION: Dry eye disease (DED) is multifactorial and characterized by a loss of tear film homeostasis that causes a chronic and progressive condition. Lipid-containing dietary supplementation (LCD), specifically docosahexaenoic acid (DHA) and ethyl eicosapentaenoic acid (E-EPA), has been shown to improve clinical signs and symptoms of DED. The aim of this study was to evaluate the safety and efficacy of LCD on the signs and symptoms of DED.

METHODS: This was a multicenter, double-masked, parallel-group, randomized, vehicle-controlled study. Subjects aged =18 years with DED diagnosis received LCD (n=77) or placebo (n=78) once daily for 8 weeks. Primary endpoints were change from baseline at Day 56 in Schirmer's test and Ocular Surface Disease Index (OSDI) scores. Secondary endpoints included tear film break-up time (TBUT), Standard Patient Evaluation of Eye Dryness (SPEED) scores, conjunctival hyperemia, and matrix metalloproteinase-9 (MMP-9) expression.

RESULTS: At Day 56, the LCD group experienced significantly improved Schirmer's test scores (p<0.001), osdi scores p><0.001), tbut p><0.001), speed scores p><0.001), conjunctival hyperemia p><0.05), and mmp-9 expression p><0.05) compared with placebo. no serious adverse events were reported.>

CONCLUSION: This study demonstrated that LCD significantly improves the symptoms of DED, including dryness and discomfort, as well as objective signs such as Schirmer's test scores, tear film break-up time, and a reduction in MMP-9 expression. (NCT05481450)