Posters

Tolerability drop profile of propylene glycol/hydroxypropyl guar-based lubricant eye drops in patients with dry eye disease

Poster Details

First Author: E.Yeu USA

Co Author(s):    S. Silverstein   S. Srinivasan                 

Abstract Details

Purpose:

Systane® Complete (propylene glycol/hydroxypropyl-guar [PG-HPG]) lubricant eye drop formulation combines a higher concentration of HPG and a lipid excipient in nano-sized droplets. This study evaluated the tolerability drop profile following a single dose of 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, 28-day, interventional study in adult patients with a clinical diagnosis of DED subtyped into aqueous deficient, evaporative and mixed dry eye. Tolerability assessment scores for four subjective symptoms (burning, stinging, blurry vision and foreign body sensation) were assessed on Day 1, immediately following instillation of first single dose of PG-HPG, using a tolerability assessment questionnaire. Tolerability profile was assessed on a 0–10 scale (0=no symptoms; 10=worst imaginable symptom experienced; 0–5=none to mild symptoms). Data were analyzed for the overall cohort and dry eye subtypes.

Results:

Of 134 patients treated (median age 59 years, female 75.4%), more than 92% reported tolerability assessment scores in 0–5 category (burning 97%; stinging 96.3%; blur 92.5% and foreign body sensation score 94.8%) after PG-HPG instillation at Day 1. Proportion of patients reporting tolerability assessment scores of 0–5, for burning, stinging, blurring and foreign body sensation, were 90.2%–100% in aqueous-deficient, 93.2%–95.5% in lipid-deficient, and 91.8%–98% in mixed DED subgroups, respectively. The median score across all DED subgroups for all four symptoms was 0.

Conclusions:

These results demonstrate that PG-HPG lubricant eye drops are well tolerated in patients with DED: aqueous deficient, evaporative, and mixed dry eye.

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