Efficacy and Safety of Phospholipid Nanoemulsion-Based Ocular Lubricant for the Management of Various Subtypes of Dry Eye Disease: A Phase IV, Multicenter Trial.

PURPOSE

To evaluate the clinical efficacy and safety of propylene glycol/hydroxypropyl-guar (PG-HPG)-based nanoemulsion (Systane Complete) lubricant eye drops in participants with dry eye disease (DED).

PARTICIPANTS AND METHODS

In this phase IV, open-label, single-arm, interventional, multicenter study, adult participants with DED - subtyped into aqueous deficient, evaporative, and mixed dry eye - were instructed to instill one drop of PG-HPG in each eye twice a day for 28 days. Endpoints included change from baseline in tear film break-up time (TFBUT) (primary) and ocular discomfort visual analog scale (VAS) score at Day 14 and TFBUT at Day 28 (secondary). Safety was assessed throughout the study. Data were analyzed for overall patient cohort and by DED subtypes.

RESULTS

A total of 134 participants received treatment (mean age: 56.6 years; female: 75.4%). At Day 14, the mean (standard deviation [SD]) TFBUT increased from 2.6 (1.00) seconds at baseline to 4.2 (2.92) seconds (mean change: 1.5 [2.80] seconds); median change was 0.8 seconds (95% CI: 0.52, 1.19) for the overall cohort; the change was maintained at Day 28 (mean change: 1.4 (2.80) seconds, median change: 0.8 seconds (95% CI: 0.49, 1.17). Subgroup analysis showed a mean change (SD) from baseline in TFBUT of 1.1 (2.41) seconds for aqueous deficient, 2.4 (3.17) seconds for evaporative, and 1.2 (2.63) seconds for mixed dry eye at Day 14, respectively. The ocular discomfort VAS score improved (decreased) from baseline at Day 14 (mean [SD] change: -17.3 [24.80]) for the overall cohort, -22.0 [21.73] for aqueous deficient, -17.6 [24.17] for evaporative and -13.1 [27.49] for mixed dry eye subgroups). Adverse events (AEs) were reported in 9 (6.7%) participants. No serious AEs were reported during the study.

CONCLUSION

Our study findings demonstrated that PG-HPG-based nanoemulsion lubricant eye drops were effective and well tolerated in participants with DED and all of its subtypes.