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W. G. Gensheimer, D. M. Kleinman, M. O. Gonzalez, D. Sobti, A. Loxley, M. Mitchnick, J. V. Aquavella; Extension of Tear Film Break-Up by Novel Formulation of Glycerin 1%. Invest. Ophthalmol. Vis. Sci. 2009;50(13):4647.
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One way to evaluate the effectiveness of an artificial tear preparation is to measure the tear film break up time (TFBUT) before and after eye drop instillation. Currently, even the best products on the market provide only limited extensions of TFBUT. Furthermore, most artificial tears lose their effectiveness after roughly one hour. Drug product formulation is critical to maximizing the benefits of an active pharmaceutical ingredient. A new formulation of glycerin 1% was compared to a market leading artificial tear product to determine if a better formulation could significantly improve the activity of commonly used ophthalmic demulcents.
This single-center, single visit, randomized, double-masked exploratory trial compared the extension of TFBUT between a new formulation of glycerin 1% and a commercially available artificial tear formulation of propylene glycol (0.3%) and polyethylene glycol (0.4%). Non-Invasive Break-Up Time (NIBUT) and Fluorescein Break-Up Time (FBUT) were measured in 3 groups of subjects (n=16) with asymptomatic to mild, mild to moderate, and moderate to severe dry eye symptoms. NIBUT was measured using the Tearscope Plus at pre-instillation and again at 15, 30, 60, and 120 minutes after instillation. FBUT was measured at 120 minutes after instillation.
The new formulation containing glycerin 1% extended NIBUT by 14.67 seconds at 15 minutes (p = 0.03) compared to pre-instillation NIBUT. The active comparator, which is a market leading product, extended NIBUT by 7.47 seconds at the same time point (p = 0.34). The new formulation of glycerin had a FBUT 4.92 seconds longer than the active comparator at 120 minutes (p = 0.12).
This study suggests glycerin 1% can be formulated to significantly prolong NIBUT at 15 minutes, and that activity for two hours after eye drop instillation is possible. A trend showing that the new glycerin 1% formulation acts longer than a market leading product at 120 minutes was seen. A new formulation of glycerin 1% is a promising therapy for dry eye disease.
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