Bausch + Lomb announces results from a clinical study of a novel daily nutritional supplement for dry eyes

(Image Credit: AdobeStock/Prostock-studio)

Bausch + Lomb Corp announced Frontiers in Ophthalmology published statistically significant results from a clinical study evaluating the efficacy and safety of a novel daily nutritional supplement formulated to address the symptoms of dry eyes.¹

According to a news release, Bausch + Lomb said it expects to launch the supplement, which features a proprietary blend of ingredients including lutein, zeaxanthin isomers, curcumin and vitamin D3, under the brand name Blink NutriTears early in the third quarter of 2024 in the United States.²

The company noted the clinical study met both primary endpoints:

• Change from baseline at day 56 (week eight) in tear production (Schirmer’s test).
• Change from baseline at day 56 in ocular symptoms measured by OSDI score.

Moreover, the company noted in its news release the study also met secondary endpoints, showing statistically significant improvements in tear-film break-up time (TBUT), osmolarity, ocular surface health, and the presence of an inflammatory marker.

Yehia Hashad, MD, executive vice president, Research & Development and chief medical officer at Bausch + Lomb, noted in the news release that more than 150 million Americans experience dry eyes.

“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,” Hashad said in the news release.

The company noted that dry eyes are a prevalent ocular surface disorder that affects millions of adults worldwide. Once a condition known to traditionally affect adults over the age of 55, dry eye is impacting a younger demographic of consumers fueled by modern-day factors such an increased use of digital devices, environmental stressors, anxiety and stress.

Nearly 70% of consumers attribute their dry eye symptoms to their use of digital devices.²

The prospective, randomized, double-blind, parallel, placebo-controlled study evaluated the efficacy and safety of NutriTears in 155 adult participants with mild dry eye symptoms (aged 18–65; median age 42). Participants were randomized to receive one NutriTears or placebo capsule (NutriTears, n=77; placebo, n=78) per day for 56 days (eight weeks) and artificial tear use was captured.²

Further, the company noted the study met both of its primary endpoints, including change in tear production and participant reports of dry eye symptoms.

• Participants consuming the daily NutriTears had significant improvements in tear production, as measured by change in Schirmer’s test scores from baseline compared to placebo to day 56 (week eight) (p<0.001 for both).
• By day 14, total OSDI scores, as well as symptoms and vision domains of the OSDI significantly improved from baseline for participants consuming the daily NutriTears versus placebo, (p<0.05 for all) and were maintained to day 56 (p<0.001).

According to the news release, secondary endpoints included improvements in ocular surface staining, participant-reported symptoms, and the inflammatory marker MMP-9 in participants consuming the daily NutriTears compared to placebo were seen at day 56.

• By day 56, participants consuming the daily NutriTears had significantly improved TBUT and tear osmolarity, versus placebo (p<0.001).
• Participants consuming the daily NutriTears supplement had significant improvements in corneal and conjunctival staining (p<0.001 for both), and inflammation, as assessed by presence of MMP-9, by day 56 (p<0.001 for each eye).
• Significant improvements in participant-reported ocular symptoms of dry eyes and participant experience of the frequency and severity of dry eye symptoms, as assessed by a SPEED questionnaire, were noted by day 14 for participants consuming the daily NutriTears versus placebo (p<0.05 for days 14 and 28) and maintained to day 56 (p<0.001).
• Participants were allowed to use artificial tears throughout the study; there was no difference between groups for artificial tear usage.

The company also noted the trial found NutriTears found to be well-tolerated. No serious adverse events were reported during the study period.

“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,” Neda Gioia, OD, CNS, founder of Integrative Vision, president, Ocular Wellness & Nutrition Society, and Blink NutriTears investigator. “This could represent a significant opportunity for consumers looking for options when it comes to long-lasting dry eye symptom relief.”

The study’s authors noted that daily consumption of the LCD supplement significantly improved the production, stability, and quality of tears, with evidence of significant reduction in ocular surface damage and inflammation, and could offer a useful adjunct to artificial tears for patients with DED.¹

“Once-daily administration of the LCD supplement was also effective in reducing dry eye symptomology and improving patient experience of DED symptoms, with significant changes reported by 2 weeks in some measures,” they wrote in the study.

Moreover, the authors concluded the trial highlights the benefits to patients with DED of anti-inflammatory and antioxidant nutritional support with this proprietary supplement, by improving their experience of symptoms, addressing the characteristic loss of tear homeostasis, and ameliorating the ocular inflammation and damage that are the basis of DED pathophysiology.¹

References:

1. Gioia, et al. A Novel Multi-Ingredient Supplement Significantly Improves Ocular Symptoms Severity and Tear Production in Patients with Dry Eye Disease: Results from a Randomized, Placebo-Controlled Clinical Trial. Front. Ophthalmol. 2024;4. 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. www.businesswire.com. Published April 25, 2024. Accessed April 25, 2024. https://www.businesswire.com/news/home/20240425411558/en/Bausch-Lomb-Announces-Statistically-Significant-Results-From-a-Clinical-Study-of-a-Novel-Daily-Nutritional-Supplement-for-Dry-Eyes