PURPOSE: Ocular surgery can induce inflammatory changes leading to ocular surface changes and accumulating damage. Subsequent symptomology and worsening tear dysfunction can impact patient post-surgical satisfaction. NutriTears (NT) is an oral supplement that improves dry eye symptoms and tear volume. Here we assess the effects of NT on ocular inflammation.

METHODS: This randomized, double-blind, placebo (PBO)-controlled study was conducted at 4 study centers in the US. The study involved 5 visits with follow-up out to Day 56 (±3 days). Participants consumed one soft gel capsule (NT or PBO) per day with their breakfast meal. Matrix metalloproteinase-9 (MMP-9) is an inflammatory mediator that is consistently elevated in the tears of patients with dry eye disease and correlates with disease severity. The presence of MMP-9 was evaluated at baseline and Day 56 using InflammaDry® MMP-9 test kits (QUIDEL®; San Diego, CA, USA).

RESULTS: Of 155 randomized participants, 116 (NT=57; PBO=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;" left eye: day 0="44," day 56="17)," whereas positive tests did not decrease in the pbo group right eye: day 0="45," day 56="48;" left eye: day 0="46," day 56="50)." 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 no serious adverse events were reported.>

CONCLUSION: The administration of one NT 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. These findings suggest NT may be a useful tool in mitigating post-surgery inflammatory processes that may drive the pathophysiology of DED.