Clinical evaluation of a novel lipid-containing lubricant eye drop with omega-3 oil and trehalose

Session Details

Session Title: Presented Poster Session: Cornea: Medical

Venue: Poster Village: Pod 2

First Author: : S.Shah UK

Co Author(s): :    M. Hom   G. Berdy   A. Verachtert   L. Downie   S. El-Harazi   H. Liu        

Abstract Details

Purpose:

Tear lipid deficiency is very common among dry eye patients, leading to rapid tear film evaporation and instability, with symptoms of discomfort and visual disturbance. This investigation assessed the clinical performance of a novel lubricant eye drop containing a nano-emulsion of lubricant polymers, osmoprotectants including the disaccharide trehalose, and emulsified flaxseed oil, a source of the omega-3 fatty acid alpha-linolenic acid.

Setting:

The University of New South Wales, NSW-AUS Professor M.T. Coroneo Pty. Ltd., NSW-AUS The University of Melbourne, VIC-AUS Ophthalmology Associates, MO-USA Charlotte Eye Ear Nose NC-USA Moyes Eye Center, PC, MO-USA Texan Eye, TX-USA Havana Research Institute, LLC, CA-USA Rochester Ophthalmological Group, PC, NY-USA Scott and Christie and Associates, PA-USA

Methods:

242 dry eye patients were enrolled in this multi-center, randomized, double-masked, controlled clinical trial. Patients used the novel eye drop containing flaxseed oil and trehalose (OM3) or a marketed lipid-containing eye drop (Refresh Optive® Advanced, ROA). Patients were instructed to dose as needed, at least 2X per day, for 90 days, following a 1-week run-in with standard aqueous tears (Refresh Plus®). The primary outcome variable was the change from baseline in Ocular Surface Disease Index (OSDI) score at Day 90. Other variables included tear break-up time (TBUT), ocular surface staining, Schirmer test, dry eye symptoms survey, and ocular safety assessment.

Results:

230 patients completed the study. OSDI scores improved 15.61 +/- 16.52 (mean +/- SD) in the OM3 group and 13.16 +/- 17.71 in the ROA group at Day 90. OM3 was non-inferior to ROA in change from baseline of OSDI. In both groups, TBUT showed > 1 sec improvement and Schirmer scores showed >1 mm improvement. For combined corneal and conjunctival staining, OM3 led to significantly greater improvements than ROA at all follow-up visits (p<0.03). OM3 group had a trend for greater improvements in dry eye symptoms. Treatment-related adverse events were numerically less for OM3 (8) than for ROA (12).

Conclusions:

A novel eye drop formulation containing flaxseed oil and trehalose was shown to be safe and effective for improving signs and symptoms of dry eye. In comparison with an existing lipid-containing eye drop, it demonstrated greater improvement in ocular surface staining, and similar improvement in other dry eye signs and symptoms during this 90 day trial. Incidence of adverse events was low for both treatments. Overall these data indicate that the novel formulation may be a useful treatment for dry eye patients.

Financial Disclosure:

is employed by a for-profit company with an interest in the subject of the presentation, travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented