NutriTears Shows Promise in Bausch + Lomb Study

Bausch + Lomb announced the results of a pivotal clinical study published in Frontiers in Ophthalmology, showcasing statistically significant efficacy and safety of their new daily nutritional supplement, Blink NutriTears, aimed at alleviating symptoms of dry eyes.

The supplement features a proprietary blend of lutein, zeaxanthin isomers, curcumin, and vitamin D3, with a planned launch in the US in early Q3 2024.

Study Outcomes:

The clinical study met all its primary endpoints, demonstrating:

1. A significant change from baseline at day 56 (week 8) in tear production as measured by Schirmer’s test.

2. A significant change from baseline at day 56 in ocular symptoms as measured by the Ocular Surface Disease Index (OSDI) score.

Furthermore, the study achieved significant results in secondary endpoints including improvements in tear-film break-up time (TBUT), osmolarity, ocular surface health, and the reduction of the inflammatory marker.

Study Design and Execution:

This prospective, randomized, double-blind, parallel, placebo-controlled study involved 155 adult participants with mild symptoms of dry eye, aged 18–65 (median age 42). They were randomized to receive either the NutriTears supplement or a placebo daily for 56 days. The use of artificial tears was also recorded but showed no significant difference between the two groups.

Key points from the trial:

1. 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 8) (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.