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M.T. Christensen, D.L. Meadows, M.R. Tudor, R.P. Stone; A Report From Clinical Evaluations of a New Liquid Gel Concept Artificial Tear . Invest. Ophthalmol. Vis. Sci. 2006;47(13):274.
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© ARVO (1962-2015); The Authors (2016-present)
To evaluate efficacy and performance characteristics of a new Concept Tear.
The Concept Tear (Alcon Labs, Inc.) is a multi–dose formulation with buffer ingredients that work in concert to provide preservative efficacy without traditional preservatives. Like original Systane® Lubricant Eye Drops, it contains PEG–400 and propylene glycol as active demulcents with HP–Guar as a gelling agent. Unlike the original Systane, it is a structured gel in the bottle. Two clinical studies are summarized herein. Study 1: 135 dry eye patients (45 per arm) were enrolled in a randomized, double masked, parallel study of 6 wks duration. Eligible patients had to demonstrate a sum > 3 NEI corneal staining score and need artificial tears at least "some of the time". Controls contained Carboxymethylcellulose 0.5% (Unit Dose) and Carboxymethylcellulose 0.5% with PURITE (Allergan, Inc). Signs/symptoms were monitored weekly. Study 2: Acute comfort & blur comparison were made between the new Concept Tear and a Carboxymethylcellulose 1% tear with PURITE (Allergan, Inc). This was a double masked, randomized, 2–period crossover study of one dose duration. Drops were administered OU per randomization. Drop instillation comfort, overall acceptability and 3 minute blur profile comparisons were made.
Study 1: A statistically significant reduction in corneal staining change from baseline for the new Concept Tear (p=0.05) was found at 6 weeks vs Carboxymethylcellulose 0.5% with a trend in favor of the concept tear (p=0.07) vs Carboxymethylcellulose 0.5% Unit Dose. A significant reduction from baseline in symptoms was observed for all products tested. Study 2: No significant differences in drop comfort was seen, but there was a significant difference favoring the Concept Tear (p=0.0008) in drop acceptability with significantly less blurring (p < 0.0001) than the Carboxymethylcellulose 1% tear.
These studies showed that the new Concept Tear demonstrated statistically significant reductions in corneal staining in a 6 wk study and was more acceptable with less blurring in an acute evaluation than a Carboxymethylcellulose 1% formulation.
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