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

ABSTRACT:

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

SUBMITTER: Yeu E 

PROVIDER: S-EPMC7478376 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature