PURPOSE: Evaporation and renewal of the tear film can be altered by multiple factors, and restoring a functional tear film in dry eye disease can be a complex challenge. Traditionally, dry eye relief has been provided by water-based artificial tears (ATs), but ATs with lipid components have emerged more recently to provide lubrication while decreasing tear evaporation. This study compared the performance and safety of two preservative-free ATs with sodium hyaluronate (SH) in patients with moderate-to-severe dry eye disease: a multicomponent 0.24% SH eye drop with carbomer and triglycerides as lipids (SH-CB-TG), and an aqueous-based comparator (C-SH) with 0.18% SH.

METHOD: In this multicentre, investigator-masked, noninferiority study, patients were randomised to SH-CB-TG or C-SH, administered 3–6 times daily for 3 months. The primary endpoint was change from baseline in the ocular surface fluorescein staining (OSFS) score (0–15 per the Oxford scheme) at Day 28 in the per-protocol population. Secondary endpoints included OSFS at 3 months, tear film break-up time, dry eye symptoms, quality-of-life questionnaire and frequency of AT instillation.

RESULTS: On Day 28, OSFS score decreased from a baseline of 5.7±1.2 to 3.6±1.6 in the SH-CB-TG group (n=45), while in the C-SH group (n=34), it decreased from 5.8±1.3 to 4.3±2.1 (95% confidence interval of the adjusted difference was below the predetermined value for noninferiority). In both groups, signs, symptoms and quality-of-life measures improved continuously through the study, with a favourable safety profile. In the SH-CB-TG group, the global score of dry eye symptoms showed a statistically significant improvement compared with the C-SH group (p<0.05).>

CONCLUSIONS: The multicomponent, lipid-containing SH-CB-TG was noninferior to the aqueous-based tear substitute in terms of ocular staining in the studied population, and may offer additional advantage in ameliorating symptoms of dry eye.