PURPOSE: Ocular surgery procedures can exacerbate or induce dry eye. Nutritional supplementation can support eye health and help mitigate pre- and post-surgical issues. NutriTears (NT) is an oral supplement containing lutein & zeaxanthin isomers, curcuminoids, and vitamin D3. This study evaluated the efficacy and safety of NT in participants with dry eye.

METHODS: This randomized, double-blind, placebo (PBO)-controlled study was conducted at 4 US study centers. Participants were required to meet the following criteria in ≥1 eye: (1) Schirmer's test without anesthesia ≤10 mm; and (2) Ocular Surface Disease Index (OSDI) test symptoms 12–40. Participants were also required to have in ≥1 eye: (1) Tear film break-up time ≤10 seconds; (2) Tear osmolarity ≥316 mOsm/L; or (3) Fluorescein corneal staining ≥1 and <3. the study involved 5 visits with follow-up out to day 56 3 days. participants consumed one soft gel capsule per day with breakfast.>

RESULTS: Of 155 randomized participants, 116 (NT=57; PBO=59) completed the study. A significant group-by-time interaction was detected for OSDI Total Score as well as the subscale domains for Symptoms, Vision and Environmental (p<0.001 for all. values for the osdi total score symptoms and vision domains were significantly lower in the nt group vs pbo at days 14 p><0.05), 28 p><0.05) and 56 p><0.001). schirmers test mean standard deviation of both eyes was 7.3 3.29 mm for nt and 7.61 2.37 mm for pbo at baseline 11.6 3.89 mm for nt and 8.22 2.44 mm for pbo at end of treatment p><0.001). one subject from each group reported 1 adverse event no serious adverse events were reported.>

CONCLUSION: The administration of one NT soft gel capsule per day for 8 weeks was effective at improving dry eye symptoms across OSDI domains and tear volume as measured by Schirmer's test compared with PBO. Given the potential impact of pre- and post-surgery dry eye symptoms on outcomes, NT may be a viable surgical adjunct.