AIM: Traditionally, dry eye relief has been provided by water-based artificial tears (ATs), but ATs with lipid components have emerged to provide lubrication while decreasing tear evaporation. This study compared 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.

METHODS: 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 (OSD-QoL) and frequency of AT instillation.

RESULTS: The primary non-inferiority endpoint (OSFS) was met, together with endpoints on symptoms. At baseline, mean (SD) global dry eye symptom scores (0–28) were 11.1 (±3.8) in the SH-CB-TG group and 9.2 (±3.8) in the C-SH group. By Day 28, scores had decreased by 3.9 (±0.5) and 2.1 (±0.5), respectively, representing a significant difference between treatment groups (-1.8, 95% CI:-3.2, -0.3; P=0.0176). At the end of three months, the treatment difference had increased to (-2.4, 95% CI:-3.8, -1.0; P=0.0010) and QoL questionnaires demonstrated a significant advantage in the SH-CB-TG group (OSD Global question, adjusted treatment difference, 8.2, 95% CI:0.8, 15.6; P=0.0306). OSD-QoL assessments showed improvement of 6 dimensions in the SH-CB-TG group and 5 dimensions in the C-SH group. There was a significant difference in 3 dimensions in favour of the SH-CB-TG group: Daily activities, Handicap and work difficulties and Acknowledgement of the disease.

CONCLUSION: The multicomponent, lipid-containing SH-CB-TG may offer additional advantages in ameliorating symptoms of dry eye.