Global ophthalmic company Bausch + Lomb (B+L) has achieved statistically significant results from a trial evaluating the efficacy and safety of its novel daily nutritional supplement for dry eye disease.
After publishing the findings in Frontiers in Ophthalmology on 24 April 2024, the company now expects to launch the supplement – featuring 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 US.
The clinical study met both primary endpoints, which were:
- Daily NutriTears consumption showed 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 Ocular Surface Disease Index (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).
Interestingly, the trial subjects were allowed to use artificial tears throughout the study, with no difference between groups for artificial tear usage reported.
“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 Dr Neda Gioia, founder of Integrative Vision, president of the 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.”
According to the company, dry eye is a prevalent ocular surface disorder affecting millions of adults worldwide. Once a condition known to traditionally affect adults over the age of 55, it is now impacting a younger demographic of consumers fuelled 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, randomised, double-blind, parallel, placebo-controlled study evaluated the efficacy and safety of NutriTears in 155 adult participants with mild dry eye symptoms (aged 18 to 65; median age 42). Participants were randomised to receive one NutriTears (77 people) or placebo capsule (78 people) per day over eight weeks, and artificial tear use was captured.
In addition to meeting both primary endpoints, key secondary endpoints were achieved and included 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). They also 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).
NutriTears was found to be well-tolerated. No serious adverse events were reported during the study period, B+L stated.
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