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Bausch + Lomb Announces Statistically Significant Results from a Clinical Study of a Novel Daily Nutritional Supplement for Dry Eyes

In April, Bausch + Lomb 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 Bausch + Lomb 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 U.S.

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.

The study also met secondary endpoints, showing statistically significant improvements in tear-film break-up time, osmolarity, ocular surface health and presence of an inflammatory marker.

“More than 150 million people experience dry eyes in the U.S.,” said Yehia Hashad, MD, executive vice president, Research & Development and chief medical officer, Bausch + Lomb. “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.”

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 as increased digital device use, environmental stressors, anxiety, and stress. Nearly 70% of consumers attribute their dry eye symptoms to digital device use.

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.

Key points from the trial:

Primary endpoints

• The study met both of its primary endpoints: 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).

Key secondary endpoints

• Significant 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.
• NutriTears was 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,” said Neda Gioia, OD, CNS, founder 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.”

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.