Clinical Evaluation Of A Multi-Ingredient Oral Supplement On Dry Eye Symptoms And Tear Volume

Ocular surgery procedures have been found to exacerbate pre-existing dry eye and to induce dry eye in patients with healthy corneas. Oral supplements are playing a larger role in the management of eye health and offering solutions to mitigate ocular issues associated with pre- and post- surgical procedures.. NutriTears (NT) is an oral supplement containing a unique combination of lutein and zeaxanthin isomers, curcuminoids, and vitamin D3 designed to improve eye hydration. The objective of this study was to evaluate the efficacy and safety of NT in participants with dry eye syndrome (DES). 

This was a randomized, double-blind, placebo-controlled study conducted at four study centers in the US, enrolling adults with DES. Clinical study registration: NCT05481450.

Participants were required to meet the following criteria in at least one eye: (1) Schirmer's test without anesthesia ≤ 10 mm; (2) Ocular Surface Disease Index (OSDI) Test symptoms between 12 and 40. Participants were also required to have in ≥1 one eye: (1) Tear film break up time ≤ 10 seconds; (2) Tear Osmolarity ≥ 316 milliosmole /L; (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 their breakfast meal.  

155 participants were randomized, of which 116 (NT, n=57; PBO, n=59) completed the study. A significant group-by-time interaction was detected for the 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 domain, and Vision domain were significantly lower in the NT group vs PBO at Day 14 (p<0.05), Day 28 (p<0.05), and Day 56 (p<0.001). For the Environmental domain, NT was significantly greater than PBO at Day 56 (p<0.001). Expressed as the mean (SD) of both eyes, baseline Schirmer’s test was 7.3 ± 3.29mm for the NT group and 7.61 ± 2.37mm for PBO.  One subject from each group reported ≥1 adverse event (AE)  but no serious AEs were reported.

The daily administration of one NT soft gel capsule over an 8-week period demonstrated effectiveness in alleviating dry eye symptoms across OSDI domains and improving tear volume, as assessed by Schirmer’s test, when compared to the placebo. Considering the potential impact of pre- and post-surgery dry eye symptoms on visual recovery and outcomes, NT may be  a viable management option in addressing this concern.