ARVO 2024: Study shows NutriTears improves signs and symptoms of DED

Recently released findings from a study on the efficacy of an oral supplement containing a proprietary blend of nutrients was found to have scientifically significant results, with some major improvements found as early as day 14 of the trial. Neda Gioia, OD, CNS, FOWNS, CFMP, who detailed these findings in one of her presentations at this year's annual Association for Research in Vision and Ophthalmology meeting from May 5-9, recently spoke with Ophthalmology Times and Optometry Times on the study.

Video Transcript

Editor's note - This transcript has been edited for clarity.

David Hutton:

I'm David Hutton of Ophthalmology Times. The Association for Research in Vision and Ophthalmology is holding its annual meeting in Seattle. Dr Neda Gioia is joining me today to discuss her presentation at the meeting titled, "Clinical Evaluation of a Multi-Ingredient Oral Supplement on Dry Eye Symptoms and Tear Volume." Thank you so much for being here. Tell us about your presentation.

Neda Gioia, OD, CNS, FOWNS, CFMP:

Thank you so much, David, for having me here today. It's very exciting to be presenting at ARVO for these posters and talking about this very unique new oral supplement that is going to be in the hands of our doctors and patients soon.

So the posters, really there's 2 posters, but I'm going to talk about 1 more extensively, and that's the one about the multi-ingredient oral supplement on dry eye symptoms and tear volume. So the poster reflects a need right now, in terms of our dry eye toolbox and that's because over 150 million Americans are suffering from dry eye syndrome, if not more, and the incidence of this is increasing globally, not just in the US. And we can connect this to many different things: lifestyle factors, general health factors, digital use, etc. So we really need more expansion in terms of our options for our patients and it's nice to have something that is a prospective, randomized, double-blind, placebo-controlled study that features this oral supplementation as used to improve dry eye symptomology and improve dry eye tear volume.

So speaking about the poster, the objective is really to test the efficacy and the safety of this novel supplement. Now, just to kind of backtrack, what is the supplement made of? It's a proprietary blend of 20 milligrams of lutein, 4 milligrams of zeaxanthin isomers, alongside curcuminoids 200 milligrams, and vitamin D3 at 600 IUs, and this proprietary blend is tested against a placebo of 600 milligrams of soybean oil. So the eligibility criteria in these patients are roughly aged 18 to 65 and it's a 4 center test in the United States, with 116 subjects roughly split evenly between the placebo and the supplement group of neutral tears. And ultimately, the way that they accepted, the investigators, these subjects into the dry eye category is they assessed the OSDI scores, and a score of between 12 to 40, alongside a Schirmer's tear volume tests, which was assessed at less than an equal to 10 millimeters by a licensed optometrist really put everyone into that eligibility category to clinically say that these patients had mild to moderate dry eye. Now, these, the subjects were tested baseline and then at day 14, day 28, and day 56.

The primary endpoint of the OSDI as well as the Schirmer's tests were pretty remarkable. The OSDI scores at day 14 start to show statistically significant improvement, which is really, really amazing, knowing how nutraceuticals work, and that's going back to the formulation most likely and the bioavailability of that formulation. And that kept improving into day 56. Alongside that the tear volume also improved around day 28, again statistically significant. Now there were secondary endpoints that all showed improvement except for 1 which was not plus or minus, it was just the same and that was the artificial tear use. And those types of tests include MMP scores, TBUT scores, corneal and conjunctival staining, SPEED scores, again another subjective point for the test subjects. And these all showed improvement as well, statistically significant around that day 56. So in 2 months, we saw so many points of improvement in tear quality, tear volume. And even more importantly, the patient's report, right, because dry eye's also something alongside quality of life. So we see those quality of life scores improve.

And really the bottom line was this NutriTears formulation, this LCD formulation that we saw tested by these investigators, it really improved dry symptom relief, again, seen as little as 2 to 4 weeks. And the clinical data just really just shows the efficacy and the safety of this proprietary blend of the lutein, zeaxanthin isomers, curcumin, and vitamin D3 as a daily supplement to help with the signs and symptoms of dry eye. So having this therapeutic potential in a supplement form to help address the signs and symptoms of dry eyes in all these patients that we're seeing is going to really give us a lot of confidence to help add to our toolbox of treatments.

Now, the second poster emphasizes how the India study, which also was done a few years prior to the USA study, showed really similar results. Now the subject number was slightly smaller. Actually, if anything, the artificial tears usage, which seemed to be used less, as early as day 14 as well, again with statistical significance. It was a 1 center study, but in conjunction with the USA study, I think we really have 2 nice, solidified ways to show that this new novel, multi-ingredient oral supplement can help with dry eye symptoms and tear volume.

Hutton:

What's the next step for your research?

Gioia:

Well, what's wonderful is that this proprietary blend has also been investigated to come straight to the shelves, to basically be applicable to doctors to help recommend and also patients to basically use to help improve their dry symptomology. So, long story short, it's going to be accessible, most likely in the second half of this year.