PURPOSE: Dry eye syndrome (DES) causes chronic discomfort and visual disturbance. Lutein/zeaxanthin, curcumin, and vitamin D3 (LCD) are anti-inflammatory ocular surface protectants that, when taken as an oral supplement, improve DES symptoms and reduce inflammation. This analysis compares LCD efficacy and safety from an Indian and a larger US study.

METHODS: These 2 double-blind, placebo-controlled, 8-week studies randomized patients 1:1 to receive either LCD or placebo (PBO) soft gels to be taken with breakfast. The Indian study was conducted at a single site compared with the multicenter US study. The primary efficacy outcomes were change in tear volume (Schirmer’s test) and symptom severity (Ocular Surface Disease Index [OSDI] score) on days 14, 28, and 56. Secondary endpoints included tear film breakup time (TBUT), tear osmolarity, symptom progression (standard patient evaluation of eye dryness [SPEED] score), ocular surface disease (corneal/conjunctival staining), and inflammation (tear film presence of MMP-9) at each timepoint.

RESULTS: In both studies (US: N=116; India: N=59), change from baseline in the LCD group was significantly improved vs PBO in tear volume (Schirmer’s test; days 28 and 56; P<0.05) and symptom severity osdi score days 14 28 and 56 p><0.05). the us study found no between-group differences in artificial tear at use but the indian study saw reduced at use with time in the lcd group. both studies however showed significant reductions in ocular inflammation tear film matrix metalloprotease-9 mmp-9 positivity at day 56 p><0.05).>

CONCLUSION: Both studies show that, vs PBO, 8 weeks of daily LCD improves factors key to positive ocular surgery outcomes: tear volume and dry eye symptoms. Additionally, LCD significantly reduced ocular inflammation at 8 weeks. In both daily eye care and pre- and postsurgical protocols, LCD may provide clinically meaningful benefits to dry eye sufferers.