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%) (SystaneÒ 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 TearscopePlusÔ 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 15min (N=16), the new formulation extended mean NIBUT by 14.67s (P=0.05) compared with 7.40s (P=0.34) by Systane. The new formulation had a mean FBUT of 4.92s longer than Systane at 120min (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 15 min, and that protective activity from this artificial tear product for 2 or more hours after eye drop instillation is possible.