title: Novel formulation of glycerin 1% artificial tears extends tear film break-up time compared with Systane lubricant eye drops.
abstract: OBJECTIVE
  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).
  
  
  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.
  
  
  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 15 min, and that protective activity from this artificial tear product for 2 or more hours after eye drop instillation is possible.
authors.affiliation: Department of Ophthalmology, Flaum Eye Institute, Rochester, New York 14642, USA.
authors.forename: William G
authors.initials: WG
authors.lastname: Gensheimer
authors.forename: David M
authors.initials: DM
authors.lastname: Kleinman
authors.forename: Mithra O
authors.initials: MO
authors.lastname: Gonzalez
authors.forename: Deepak
authors.initials: D
authors.lastname: Sobti
authors.forename: Eugene R
authors.initials: ER
authors.lastname: Cooper
authors.forename: Gerard
authors.initials: G
authors.lastname: Smits
authors.forename: Andrew
authors.initials: A
authors.lastname: Loxley
authors.forename: Mark
authors.initials: M
authors.lastname: Mitchnick
authors.forename: James V
authors.initials: JV
authors.lastname: Aquavella
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D015352:Dry Eye Syndromes / Q000188:drug therapy* / Q000378:metabolism; D005079:Excipients / Q000737:chemistry; D005260:Female; D005990:Glycerol / Q000008:administration & dosage / Q000737:chemistry / Q000627:therapeutic use*; D006801:Humans; D008153:Lubrication; D008297:Male; D009883:Ophthalmic Solutions / Q000008:administration & dosage / Q000737:chemistry / Q000627:therapeutic use*; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000737:chemistry / Q000627:therapeutic use*; D011107:Polylysine / Q000031:analogs & derivatives / Q000737:chemistry; D011446:Prospective Studies; D012720:Severity of Illness Index; D013666:Tears / Q000378:metabolism*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D005079:Excipients; D009883:Ophthalmic Solutions; C443714:polylysine-graft-(poly(ethylene glycol)); D011107:Polylysine; D011092:Polyethylene Glycols; D005990:Glycerol