PURPOSE: Artificial tears remain the most common treatment for the symptoms of dry eye. In a clinical study of a novel lipid-containing eye drop (BTC) versus an existing non-lipid eye drop (NLED), the novel agent provided a significant improvement in overall comfort and demonstrated non-inferiority to comparator drops. Here we present additional patient-reported outcomes and safety assessments.

METHODS: This was a prospective, double-masked, multicenter study that enrolled subjects who self-reported symptoms of ocular dryness in the prior 3 months and/or were habitual users of tear supplements. Participants were evaluated for dry eye symptoms and signs at Visit 1 (baseline), Visit 2 (Day 7±1), and Visit 3 (Day 30±2). The primary hypothesis of the study was that BTC is non-inferior to NLED with respect to change in ocular comfort from baseline at 30-day follow-up. Additional assessments included quality of vision, ocular symptoms, and corneal staining.

RESULTS: The change in overall vision quality was statistically significantly greater in the BTC group versus the NLED group at both Day 7 (least squares mean difference [95% confidence interval (CI)] 8.0 [0.7, 15.4]) and Day 30 (9.3 [1.7, 17.0]); however, overall scores were numerically similar between groups at all timepoints. The proportion of eyes with reported ocular symptoms was not statistically significantly different between groups at Day 7 (odds ratio [OR; 95% CI] 0.967 [0.528, 1.770]) or Day 30 (OR [95% CI] 1.160 [0.610, 2.203]). At baseline, moderate-to-severe eye dryness was reported by 46/154 (29.9%) of participants in the BTC group and 56/162 (34.6%) of participants in the NLED group. By 30-day follow-up, this decreased to four participants (2.6%) in the BTC group and six (3.8%) in the NLED group. The proportion of subjects with Grade ≥2 corneal staining was not statistically significantly different between study groups (OR [95% CI] 1.601 [0.178, 19.616], p=0.6757). There were no cases of Grade ≥3 corneal staining or any other biomicroscopy findings, and no corneal infiltrates observed during the study.

CONCLUSIONS: While this study did not select or group participants by dry eye category, it may be hypothesized that patients with lipid-deficient dry eye/meibomian gland dysfunction might benefit from the addition of a lipid component to the artificial tear formulation without compromising quality of vision.