Corneal staining reductions observed after treatment with Systane Lubricant Eye Drops.
BACKGROUND
Because of the added emphasis on ocular surface damage included in the Dry Eye Workshop's revised definition of dry eye, an evaluation of corneal staining reductions was conducted for propylene glycol/polyethylene glycol 400-based artificial tear drops (Systane Lubricant Eye Drops; Alcon Laboratories, Fort Worth, TX, USA).


METHODS
An analysis was conducted on the percent change from baseline in mean corneal staining scores as reported in two previously published, randomized, double-masked, 6-week clinical studies of Systane. A descriptive comparison was also made between the outcome of the composite analysis and data obtained for Optivetrade mark Lubricant Eye Drops (Allergan, Inc., Irvine, CA, USA). Finally, results were reviewed for an open-label study that investigated corneal staining over a 5-week period after patients discontinued Systane therapy.


RESULTS
The composite analysis included 107 Systane-treated patients. The results showed that Systane consistently reduced corneal staining at each visit; the percent change from baseline to day 42 (exit) was 47.1% (P<0.0001). After discontinuing Systane, immediate and significant increases in corneal staining were reported by 20 patients, with an overall increase from baseline to day 35 (exit) of 195.0% (P<0.0001).


CONCLUSIONS
Evaluations of sum corneal ocular staining scores provide clinically meaningful evidence of dry eye severity, and are an important indicator of dry eye disease progression. The results of the composite analysis of two peer-reviewed studies indicate that Systane significantly reduced corneal staining (P<0.0001), indicating a reduction in the severity of dry eye. Finally, discontinuation of Systane results in a rapid increase in corneal staining that further confirms Systane's ability to maintain ocular surface health.
Christensen
Mike T
MT
Alcon Laboratories, Ltd., Fort Worth, Texas 76134-2099, USA. Mike.Christensen@alconlabs.com
D003315:Cornea / Q000187:drug effects* / Q000473:pathology; D003941:Diagnostic Techniques, Ophthalmological; D004338:Drug Combinations; D015352:Dry Eye Syndromes / Q000175:diagnosis / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D009883:Ophthalmic Solutions; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000627:therapeutic use*; D019946:Propylene Glycol / Q000008:administration & dosage / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic
D004338:Drug Combinations; D009883:Ophthalmic Solutions; D011092:Polyethylene Glycols; D019946:Propylene Glycol