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Milton M Hom, Gregg J. Berdy, Laura Elizabeth Downie, Sherif El-Harazi, Anthony Verachtert, Haixia Liu, Cindy Carlisle-Wilcox, Peter Simmons, Joseph Glennon Vehige; Clinical evaluation of a novel lipid-containing lubricant eye drop with omega-3 oil and trehalose. Invest. Ophthalmol. Vis. Sci. 2017;58(8):2671.
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© ARVO (1962-2015); The Authors (2016-present)
Tear lipid deficiency is common among dry eye patients, leading to rapid tear film evaporation and instability, with symptoms of discomfort and visual disturbance. This investigation tested the clinical performance of a novel eye drop containing lubricant polymers, osmoprotectants including the disaccharide trehalose, and emulsified flaxseed oil, a source of the omega-3 fatty acid alpha-linolenic acid.
242 dry eye subjects were enrolled in this multi-center, randomized, double-masked, controlled clinical trial. Subjects used either the novel eye drop containing flaxseed oil and trehalose (OM3) or a marketed lipid-containing eye drop (Refresh Optive® Advanced, ROA,). Both products were supplied in identical unit-dose vials, and subjects dosed as needed, at least 2X per day, for 90 days, following a 1-week run-in with a standard aqueous tear (Refresh Plus®). The primary outcome variable was the change from baseline in Ocular Surface Disease Index (OSDI) score at Day 90. Other study variables included tear break-up time (TBUT), ocular surface staining, Schirmer test, dry eye symptoms survey, and ocular safety assessment.
230 subjects (95%) completed the study, with no significant differences between groups at baseline. 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. Other variables also improved in both groups, with > 1 sec improvement in TBUT and >1 mm improvement in Schirmer scores. OM3 use led to significantly greater improvements in combined corneal and conjunctival staining than ROA at all follow-up visits (p<0.03). There was also a trend for greater improvements in dry eye symptoms with OM3, and the number of treatment-related adverse events was numerically less for OM3 (8 total) than for ROA (12).
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.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.
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