Abstract
Purpose :
NutriTears® (NT) is an oral supplement containing a unique combination of lutein and zeaxanthin isomers, curcuminoids, and vitamin D3 designed to improve eye hydration. An initial clinical trial of NT was conducted at a single center in India to evaluate the efficacy and safety of NT in participants with dry eye syndrome (DES). A second study was conducted at 4 centers in the US. Here we explore similarities and differences between the two clinical studies.
Methods :
Both studies were prospective, randomized, double-blind, and placebo-controlled. Each enrolled healthy adults with mild-to-moderate DES, randomized 1:1 to receive NT or placebo (PBO) as a single soft-gel capsule consumed once daily with breakfast. Both studies involved assessments on days 14, 28 and 56, with the primary efficacy outcomes being tear volume (Schirmer’s test) and symptom severity (Ocular Surface Disease Index [OSDI] score).
Results :
In the India study, 59 participants completed the study vs 116 in the US study. In both studies, tear volume (mean of both eyes by Schirmer’s test) was significantly increased in the NT group vs PBO by Day 28. Similarly, severity of symptoms was significantly improved (decrease in OSDI score) vs PBO by Day 14 in both studies. Secondary efficacy endpoints were comparable between the two studies, and NT did not significantly alter blood safety metrics or resting vital signs in either population. No serious AEs were reported during either study. However, while the Indian study demonstrated a significant reduction in use of artificial tears (AT) over time for those receiving NT vs PBO (seen after 14 days), there were no statistically significant differences in the reported frequency of AT use in the US study.
Conclusions :
The recent study in the US supports the earlier conclusions from the Indian study: daily administration of one NT capsulefor 8 weeks is effective at improving dry eye symptoms and tear volume compared with placebo. Regardless of population, NT has the potential to provide clinically meaningful benefit as an adjuvant to AT in individuals with dry eye.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.