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J.G. Vehige, C. Carlisle, C. Felix, P.A. Simmons, J. Stoecker; Clinical Trial Results of a New Emulsion-based Dry Eye Treatment . Invest. Ophthalmol. Vis. Sci. 2003;44(13):2449.
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Purpose: Current artificial tears contain one or more ophthalmic demulcents in aqueous solution, and primarily supplement the aqueous and mucin components of the tears. New emulsion-based artificial tears have been developed containing a polar oil within an aqueous demulcent formula. Upon application, the oil is released and functions to enhance the lipid layer of the tear film, stabilizing and improving function of all three tear layers. This study investigates the clinical performance of three investigational emulsion eye drop formulas. Methods: 217 subjects with mild to moderate dry eye were recruited for this randomized, double-masked, multicenter, parallel-group trial. All subjects currently used a marketed artificial tear, and analysis was made on change from baseline. Each subject used one of the three investigational formulas at least twice daily for three months. Signs and symptoms of dry eye were assessed at days 0 (baseline), 7, 30, 60 and 90. Assessments included rating of subjective "dryness", the Ocular Surface Disease Index (OSDI©), corneal and conjunctival staining, Schirmer test, fluroescein tear break-up time (TBUT), and an acceptability/preference questionnaire Results: Within each of the three treatment groups, significant improvement from baseline (p<0.001) was achieved for subjective dryness and OSDI at all follow-up visits. TBUT significantly improved for two of three formulas (p<0.014). Safety, tolerability and overall performance of the three formulas were similar. The questionnaire results were generally favorable and mirrored the overall clinical results. In general, there were more significant improvements in moderate subjects than in mild subjects. Conclusions: These clinical data indicate that an emulsion-based eye drop may have enhanced benefit for mild to moderate dry eye subjects over conventional artificial tears. This is presumably due to the combination of ophthalmic demulcents with the unique ability of an emulsion to enhance the tear film lipid layer, providing a higher degree of tear stabilization.
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