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Peter Simmons, Cindy Carlisle, Genming Shi, Joseph Vehige; Clinical Comparison of Lipid-based and Aqueous Lubricant Eye drops. Invest. Ophthalmol. Vis. Sci. 2013;54(15):4329.
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Recent research has indicated that a majority of dry eye patients have an evaporative component to the etiology of their condition. Lipid-containing eye drops have been proposed as a means to reduce the rate of evaporation of the tear film, to provide better protection of the ocular surface from drying and the resulting hyperosmotic stress. In the past, lipid-containing eye drops have been associated with patient discomfort, irritation, and blur. This clinical study compared a new lipid-containing eye drop designed to reduce these issues, with aqueous eye drops.
A total of 315 subjects with signs and symptoms of dry eye were enrolled in this multicenter, investigator-masked, randomized clinical trial. They received 1 of 4 eye drop formulations: A unit-dose investigational formula containing lipid, a marketed unit-dose aqueous drop (Refresh Optive Sensitive), a marketed multidose lipid-containing eye drop (Refresh Optive Advanced), or a marketed multidose aqueous drop (Refresh Optive), in a ratio of 2:2:1:1, respectively. Subjects were instructed to instill 1 to 2 drops of the assigned study product in each eye as needed, but at least 2 times daily, for 30 days. The endpoints investigated were changes from baseline in Ocular Surface Disease Index (OSDI), tear breakup time (TBUT) and ocular surface staining at the Day 30 visit, as well as adverse events, comfort and acceptability.
All groups showed improvement from baseline in OSDI at Day 30 (p<0.001). The investigational lipid-containing unit-dose eye drop was found to be non-inferior to the marketed aqueous unit-dose eye drop. Similarly, TBUT was improved in all groups. All treatment groups had a low and similar incidence of adverse events. Acceptability scores were similar among groups.
This study demonstrates that both unit-dose and multi-dose lipid-containing eye drops have similar efficacy, safety, and acceptability as aqueous drops, indicating that they can be used with all dry eye patients to improve evaporative problems without compromising overall clinical performance and patient comfort.
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