Novel formulation of glycerin 1% artificial tears extends tear film break-up time compared with Systane lubricant eye drops

Journal of Ocular Pharmacology and Therapeutics : the Official Journal of the Association for Ocular Pharmacology and Therapeutics
William G GensheimerJames V Aquavella

Abstract

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(®) Lubricant Eye Drops; Alcon, Fort Worth, TX). 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™ 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. 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 stat...Continue Reading

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Citations

Apr 5, 2016·Journal of Ophthalmology·Christopher D ConradyBhupendra C K Patel
Jul 15, 2015·The Ocular Surface·Raquel C BarrosDeepak Halenahally Veeregowda
Feb 26, 2016·The Cochrane Database of Systematic Reviews·Andrew D PuckerJason J Nichols
Apr 11, 2019·Polymers·Marta Vicario-de-la-TorreIrene T Molina-Martínez
Nov 1, 2020·International Journal of Pharmaceutics·Sudeep Kumar GadeVenkata Vamsi Krishna Venuganti
Sep 19, 2019·Langmuir : the ACS Journal of Surfaces and Colloids·Wenqing YanEdmondo M Benetti

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Clinical Trials Mentioned

NCT00681265

Software Mentioned

Eyeon Protect
Eyeon
Systane

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