Daily Nutritional Supplement Achieves Improvement in Dry Eye Symptoms

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A novel nutritional supplement of lutein, zeaxanthin isomers, curcumin, and vitamin D3 (LCD) demonstrated therapeutic potential as a once-daily treatment for patients with dry eye disease (DED) in a recent randomized clinical trial.¹

DED impacts millions of adults worldwide, with symptoms that cause wide-ranging morbidity—in addressing this issue, this unique nutritional supplement achieved statistically significant improvements in the severity of ocular symptoms and tear production in DED.

“These data suggest consumption of this new once-daily nutritional supplement may help restore tear film homeostasis by addressing the key root causes of dry eyes,” Neido Gioia, OD, CNS, the president of Ocular Wellness & Nutrition Society, said in a statement.² “This could represent a significant opportunity for consumers looking for options when it comes to long-lasting dry eye symptom relief.”

A multifactorial disease, DED is characterized by a loss of homeostasis leading to a cycle of tear film instability, tear hyperosmolarity, and inflammation, triggering inflammatory responses.³ Artificial tears mark the mainstay treatment approach and are typically used over the long term, indicating the chronic nature of the disease.

Lifestyle changes also mark the first steps to reduce the effect of DED symptoms and involve improving general wellness through adequate sleep, hydration, and nutrition. Oral nutrition supplementation is supported by growing evidence based on the anti-inflammatory and antioxidant effects on DED pathophysiology.⁴

This multi-ingredient supplement formulation, comprised of LCD, achieved protective and anti-inflammatory properties in recent ocular models.¹ In this prospective, randomized, double-blind, parallel, placebo-controlled study, investigators evaluated the efficacy and safety of the multi-ingredient supplement in a large population of adult participants with DED.

Adult participants with clinically diagnosed DED were randomized to receive one LCD supplement capsule (lutein 20 mg, zeaxanthin isomers 4 mg, curcumin 200 mg curcuminoids, and vitamin D3 600 IU), or placebo per day for 8 weeks. Participants consumed one capsule at the same time each morning, after food, for 56 days.

A total of 155 adult participants with mild dry eye symptoms were randomized to receive one supplement (n = 77) or placebo (n = 78) capsule per day for 56 days. Artificial tear usage was measured. The primary efficacy endpoints, changes in tear volume (Schirmer’s test), and ocular symptoms (Ocular Surface Disease Index [OSDI]) were assessed at baseline, Day 14, Day 28, and Day 56.

Meeting its primary endpoints, the trial showed significantly better Schirmer’s test scores in the daily nutritional supplement cohort than placebo at Day 56 (P <.001 for both). By Day 14, the total OSDI scores, including the symptoms and vision domains, were significantly improved from baseline in the LCD cohort (P <.05 for all) and maintained to day 56 (P <.001).

Regarding key secondary endpoints, the LCD cohort showed significantly improved tear film break-up time (TBUT) and tear film osmolarity by Day 56 versus placebo (P <.001). Other secondary endpoints included significant improvements in corneal and conjunctival staining (P <.001 for both) and inflammation (P <.001 for each eye) in the LCD group.

There were additionally notable changes in the Total Standard Patient Evaluation of Eye Dryness (SPEED) score, with scores for the frequency and severity domains significantly improved by Day 14 for LCD versus placebo (P <.05 for all) and maintained to Day 56 (P <.001).

Safety data revealed the nutritional supplement was well-tolerated, with no serious adverse events reported during the study. As participants were allowed to use artificial tears throughout the period, investigators identified no difference between groups for artificial tear usage.

Bausch + Lomb Corporation, the supplement’s manufacturer, has announced its expectation to launch the proprietary blend of ingredients as Blink NutriTears in the third quarter of 2024 in the US.

“More than 150 million people experience dry eyes in the US,” Yehia Hashad, MD, executive vice president, research and development and chief medical officer, Bausch + Lomb, said in a statement. “We believe Blink NutriTears will offer a novel nutritional option that can provide dry eye symptom relief in as little as two to four weeks.”

References

1. _{Gioia N, Gerson J, Ryan R, Barbour K, Poteet J, Jennings B, Sharp M, Lowery R, Wilson J, Morde A, Rai D, Padigaru M and Periman LM (2024) A novel multi-ingredient supplement significantly improves ocular symptom severity and tear production in patients with dry eye disease: results from a randomized, placebo-controlled clinical trial. Front. Ophthalmol. 4:1362113. doi: 10.3389/fopht.2024.1362113}
2. _{Bausch + Lomb Announces Statistically Significant Results From a Clinical Study of a Novel Daily Nutritional Supplement for Dry Eyes. Bausch + Lomb News Releases. April 25, 2024. Accessed May 2, 2024. https://www.bausch.com/news/?id=206.}
3. _{Sheppard J, Shen Lee B, Periman LM. Dry eye disease: identification and therapeutic strategies for primary care clinicians and clinical specialists. Ann Med. 2023;55(1):241-252. doi:10.1080/07853890.2022.2157477}
4. _{Pellegrini M, Senni C, Bernabei F, et al. The Role of Nutrition and Nutritional Supplements in Ocular Surface Diseases. Nutrients. 2020;12(4):952. Published 2020 Mar 30. doi:10.3390/nu12040952}