Benefits
Eye moisture: tear volume and tear film stability
In two 8-week placebo-controlled trials (60 and 155 adults with diagnosed dry eye), the blend increased tear volume on the Schirmer test and lengthened tear film break-up time more than placebo, and tear osmolarity improved. Both trials were funded by the ingredient maker and have not been repeated independently.
Eye comfort scores within 2 weeks
Participants rated their eye symptoms on standard questionnaires (OSDI and SPEED). In both trials scores improved more than with placebo by day 14 and the difference held to day 56. These are self-reported symptoms in people with diagnosed dry eye, measured over 8 weeks only.
Ocular surface staining and a tear inflammation marker
Both trials reported less corneal and conjunctival staining, a sign of surface irritation, and lower tear MMP-9, an inflammation marker, after 8 weeks than with placebo. These are marker changes in people with diagnosed dry eye, measured in maker-funded trials.
Artificial tear use
In the 60-person trial, the 15 supplement users who used eye drops cut average use from 2.47 to 0.73 times a day by weeks 5 to 8, while placebo use barely changed. In the 155-person trial, the share still using drops at day 56 did not differ between groups (42% versus 47%), so do not expect to stop using drops.
Mechanism of action
Formula design
The maker combined lutein and zeaxanthin, curcuminoids and vitamin D3 in one softgel. The trials tested only the finished blend against placebo, so no effect can be assigned to any single ingredient.
Tear inflammation marker
In both trials the tear inflammation marker MMP-9 fell more with the blend than with placebo, which fits the design aim of calming inflammation at the eye surface. How each ingredient contributes was not measured.
Clinical trials
Single-center randomized, placebo-controlled trial of lutein 20 mg, zeaxanthin 4 mg, curcuminoids 200 mg and vitamin D3 600 IU versus soybean oil placebo for 8 weeks. Primary outcomes were Schirmer tear volume and OSDI symptom score. Sponsored in full by OmniActive Health Technologies. (Radkar et al. 2021, Ophthalmol Ther)
60 adults with mild to moderate dry eye; 59 completed (30 supplement, 29 placebo).
Compared with placebo at day 56, the blend improved Schirmer test, OSDI, tear break-up time, SPEED score, ocular surface staining, tear osmolarity (P=0.0005) and MMP-9 (P=0.0017). OSDI was already better at day 14. Among the 15 supplement users who used artificial tears, average use fell from 2.47 to 0.73 times a day by days 29 to 56; placebo use stayed about 2.6 times a day. No safety issues were reported.
Prospective randomized, double-blind, parallel, placebo-controlled trial of the same blend for 56 days. Primary outcomes were Schirmer tear volume and OSDI symptom score. Funded by OmniActive with support from Bausch + Lomb; employees of both companies were authors. (Gioia et al. 2024, Front Ophthalmol (Lausanne))
155 adults aged 18 to 65 with clinically diagnosed dry eye randomized (77 supplement, 78 placebo); 116 completed and were analyzed.
The trial met both primary endpoints: Schirmer test and OSDI improved more than placebo at day 56 (P<0.001 for both). OSDI and SPEED scores were better by day 14. Tear break-up time, osmolarity, surface staining and MMP-9 also improved by day 56. Artificial tear use did not differ between groups (42.1% versus 47.5% still using drops, P=0.562). One adverse event in each group (nosebleeds with the supplement, blurred vision with placebo); none serious.