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Novel formulation of glycerin 1% artificial tears extends tear film break-up time compared with Systane lubricant eye drops.
- Source :
-
Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics [J Ocul Pharmacol Ther] 2012 Oct; Vol. 28 (5), pp. 473-8. Date of Electronic Publication: 2012 May 03. - Publication Year :
- 2012
-
Abstract
- 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(®) Lubricant Eye Drops; Alcon, Fort Worth, TX).<br />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™ 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.<br />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).<br />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.
- Subjects :
- Adult
Double-Blind Method
Dry Eye Syndromes metabolism
Excipients chemistry
Female
Glycerol administration & dosage
Glycerol chemistry
Humans
Lubrication
Male
Ophthalmic Solutions administration & dosage
Ophthalmic Solutions chemistry
Polyethylene Glycols administration & dosage
Polyethylene Glycols chemistry
Polylysine analogs & derivatives
Polylysine chemistry
Prospective Studies
Severity of Illness Index
Time Factors
Treatment Outcome
Dry Eye Syndromes drug therapy
Glycerol therapeutic use
Ophthalmic Solutions therapeutic use
Polyethylene Glycols therapeutic use
Tears metabolism
Subjects
Details
- Language :
- English
- ISSN :
- 1557-7732
- Volume :
- 28
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics
- Publication Type :
- Academic Journal
- Accession number :
- 22554205
- Full Text :
- https://doi.org/10.1089/jop.2011.0053