Novel Formulation of Glycerin 1% Artificial Tears Extends Tear Film Break-Up Time Compared with Systane Lubricant Eye Drops

作者：Gensheimer William G; Kleinman David M; Gonzalez Mithra O; Sobti Deepak; Cooper Eugene R; Smits Gerard; Loxley Andrew; Mitchnick Mark; Aquavella James V^*

来源：Journal of Ocular Pharmacology and Therapeutics, 2012, 28(5): 473-478.

DOI：10.1089/jop.2011.0053

Purpose: To evaluate the effectiveness of glycerin 1% formulated with the novel and proprietary ophthalmic excipient poly(l-lysine)-graft-poly(ethylene glycol) (PLL-g-PEG) (Eyeon Particle Sciences LLC) in extending tear film break-up time (TFBUT) compared with a market-leading artificial tear formulation of propylene glycol (0.3%) and polyethylene glycol (0.4%) (Systane (R) Lubricant Eye Drops; Alcon, Fort Worth, TX).
Methods: This prospective single-center, single visit, randomized, double-masked exploratory trial compared the new formulation and Systane using TFBUT. Noninvasive break-up time (NIBUT) was measured in subjects with asymptomatic to mild (n = 5), mild to moderate (n = 5), and moderate to severe (n = 6) dry eye disease using the TearscopePlus (TM) at pre-instillation and again at 15, 30, 60, and 120 min after instillation. Fluorescein break-up time (FBUT) was measured at 120 min after instillation.
Results: At 15 min (N = 16), the new formulation extended mean NIBUT by 14.67 s (P = 0.05) compared with 7.40 s (P = 0.34) by Systane. The new formulation had a mean FBUT of 4.92 s longer than Systane at 120 min (P = 0.12). With outliers removed (N = 13), the difference between the mean NIBUT change from baseline for the new formulation and Systane at 120 min was statistically significant (P = 0.03).
Conclusions: This study demonstrates that PLL-g-PEG as a polymer excipient in artificial tears is effective in improving the performance of demulcents to significantly prolong NIBUT at 15min, and that protective activity from this artificial tear product for 2 or more hours after eye drop instillation is possible.

• 出版日期2012-10