Posters

Efficacy of propylene glycol/hydroxypropyl guar-based lubricant eye drops in reducing ocular discomfort in patients with dry eye disease

Poster Details

First Author: E.Yeu USA

Co Author(s):    J. Tauber   S. Silverstein   S. Srinivasan   M. Venkiteshwar           

Abstract Details

Purpose:

SYSTANE® Complete (propylene glycol/hydroxypropyl guar [PG/HPG]) lubricant eye drop formulation developed using advanced nano-droplet technology, helps replenish a deficient tear film. This study evaluated the improvement in ocular discomfort assessment after 14 days’ treatment with PG/HPG lubricant eye drops in patients with dry eye disease (DED).

Setting:

A Phase IV clinical study conducted at six centers across North America and Europe (ClinicalTrials.gov identifier NCT03492541)

Methods:

This was an open-label, single-arm, interventional study. Adult patients with a clinical diagnosis of DED (subtyped into aqueous deficient, lipid deficient and mixed dry eye) were included. Eligible patients received 1 drop of PG/HPG, twice daily for 28 days. The change from baseline in global ocular discomfort visual analogue scale (VAS) score (composite of frequency and severity discomfort scores (0 to 100) was assessed at Day 14. Data were analyzed for the overall cohort and by dry eye subtypes.

Results:

Of 134 patients who received the study treatment, 130 completed the study. The median age of patients was 59 years, and 75.4% were female. Number of patients per subtype were similar (aqueous-deficient [n=41]; lipid-deficient [n=44]; mixed [n=49]). The mean (range) global ocular discomfort VAS score decreased from 46.7 (25–67.8) at baseline to 29.3 (10.5–47.0) at Day 14 (change: −17.3 units) for the overall cohort. Subtype analysis showed a mean change from baseline in ocular discomfort VAS score of −22.0 (−65–21) for aqueous-deficient, −17.6 (−59–61) for lipid-deficient, and −13.1 (−78–45) for mixed subtypes at Day 14.

Conclusions:

PG/HPG lubricant eye drops decreased ocular discomfort in patients with DED with a notable improvement reported in all dry eye subtypes after 14 days of treatment. These results show that PG-HPG lubricant eye drops provide effective symptomatic relief from ocular discomfort in patients with DED.

Financial Disclosure:

is employed by a for-profit company with an interest in the subject of the presentation, receives consulting fees, retainer, or contract payments from a competing company, receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented