Bausch + Lomb Corporation 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 (TBUT), 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, M.D., 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
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.