PURPOSE: If left unchecked, the chronic inflammation of dry eye drives ocular surface change and accumulating damage, which can lead to increased symptomology, irritation, and worsening tear dysfunction. NutriTears® (NT) is an oral supplement containing a unique combination of lutein and zeaxanthin isomers, curcuminoids, and vitamin D3. In a study evaluating the efficacy and safety of NT in participants with dry eye syndrome, the effect of NT on the presence of matrix metalloproteinase-9 (MMP-9) in tears was assessed.

METHODS: This randomized, double-blind, placebo (PBO)-controlled study was conducted at four study centers in the US. The study involved five visits with follow-up out to Day 56 (± 3 days). Participants consumed one soft gel capsule per day with their breakfast meal. The presence of MMP-9 was assessed using InflammaDry® MMP-9 test kits (QUIDEL®; San Diego, CA, USA).

RESULTS: 155 participants were randomized, of which 116 (NT, n=57; PBO, n=59) completed the study. The presence of MMP-9 in the right and left eyes was significantly different between groups at Day 56 (both values p<0.001) as the number of positive tests in the nt group decreased right eye: day 0="46," day 56="15," -67.39 left eye: day 0="44," day 56="17," -61.36 whereas positive tests did not decrease in the pbo group right eye: day 0="45," day 56="48," 6.67 left eye: day 0="46," day 56="50;" 8.70. moreover corneal staining and conjunctival staining were significantly improved in the nt versus pbo groups at day 56. one subject from each group reported 1 adverse event during the study but no serious adverse events were reported in either group.>

CONCLUSIONS: The administration of one NT soft gel capsule per day for 8 weeks was associated with evidence of significant improvements in inflammation, as assessed by corneal and conjunctival staining and presence of MMP-9 at Day 56. Taken together with published data on improved tear quantity and quality, these findings suggest NT is associated with improvement in inflammatory processes that drive the pathophysiology of dry eye syndrome.