Clinical evaluation of an oil-based lubricant eyedrop in dry eye patients with lipid deficiency

Purpose: To evaluate and compare the efficacy of a lipid-based lubricant eyedrop formulation (hydroxypropyl guar/propylene glycol/phospholipid [HPG/PG/PL]) with preservative-free saline for the treatment of dry eye. Methods: This was a prospective, multicenter, randomized, single-masked, parallel-group phase 4 clinical study. Patients >= 18 years diagnosed with dry eye received 1 drop of saline 4 times daily (QID) for 15 days during a run-in phase, followed by randomization. Patients then instilled HPG/PG/PL or saline QID through day 35 and as needed through day 90. Change in tear film break-up time (TFBUT), change in total ocular surface staining (TOSS) score, and Impact of Dry Eye on Everyday Life (IDEEL) were evaluated on day 35. Results: Increase in TFBUT from baseline to day 35 was assessed during the interim and final analyses. Mean +/- SE difference between the HPG/PG/PL (n = 110) and saline groups (n = 100) was 1.3 +/- 0.4 seconds (interim analysis; 95% confidence interval [CI] 0.5-2.1 seconds; p = 0.0012) and 1.0 +/- 0.3 seconds (final analysis; 95% CI 0.4-1.6 seconds; p = 0.0011), demonstrating the superiority of HPG/PG/PL. The mean +/- SE difference between the HPG/PG/PL and saline groups for IDEEL treatment effectiveness scores was 16.0 +/- 3.6 (95% CI 8.9-23.1; p<0.0001). No significant differences in TOSS scores or IDEEL inconvenience scores were observed between treatment groups. Conclusions: Thirty-five days of QID HPG/PG/PL treatment resulted in a statistically significant improvement in TFBUT and IDEEL treatment effectiveness scores compared with saline but not in TOSS or IDEEL treatment inconvenience scores. HPG/PG/PL was well-tolerated by patients.