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`ARVO Annual Meeting Abstract I May 2006
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`Preservative Efficacy Of A New Lubricant Eye
`Drop Without Traditional Preservatives
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`R.A. Rosenthal' B.A. Schiech; S.L. Buck
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`+ Author Affiliations & Notes
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`Investigative Ophthalmology & Visual Science May 2006, Vol.47, 5586. doi:
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`Abstract
`Purpose: : Products provided in multi -dose containers must be adequately preserved in
`order to prevent contamination during repeated use. Traditional preservatives can cause
`irritation to the eye, but a product without preservatives may potentially become
`contaminated during use. The purpose of this study was to compare a new lubricant eye
`drop formulation to several marketed tear products.
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`Methods:: SYSTANE® Free Lubricant Eye Drops, a new tear formulation, was compared to
`marketed tear products by a method based on the United States Pharmacopeia
`preservative effectiveness test. The new eye drop formulation contains no traditional
`preservatives. Its preservative performance is based on a balanced composition of
`commonly used buffers and ions. The marketed products tested included preserved
`products: GenTeal artificial tears (Novartis, sodium perborate), Refresh Tears eye drops
`(Allergan, oxychloro complex), and Soothe emollient eye drops (Alimera,
`polyhexamethylene biguanide). The products were challenged with bacteria
`(Staphylococcus aureus, Pseudomonas aeruginosa, and Escherichia coli), and fungi (Candida
`albicans and Aspergillus niger) and sampled for survivors at 7, 14, and 28 days post
`inoculation. The number of survivors was determined using standard microbiological
`dilution pour -plate techniques.
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`Results:: The results showed that the new eye drop formulation and the marketed
`products tested met the USP preservative efficacy standards. Previous studies showed that
`the new eye drop formulation also met ISO preservative efficacy standards. All four
`products showed greater than a 3 -log reduction of the challenge bacteria throughout the
`test. The new eye drop formulation showed a 4 -5 log reduction of the three bacteria at Exhibit 1044
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`each sample time. In addition, all products tested showed substantial anti -fungal activity.
`The new eye drop formulation showed approximately a 3 -4 log reduction of the two
`challenge fungi by day 28.
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`Conclusions: : The results demonstrate that the new eye drop formulation, SYSTANE Free,
`was comparable in preservative efficacy to marketed tear products (Soothe, Refresh Tears,
`or GenTeal). Moreover, SYSTANE® Free Lubricant Eye Drops has good preservative efficacy
`and prevents contamination of the product.
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`Keywords: cornea: tears /tear film /dry eye microbial pathogenesis: experimental studies
`Staphylococcus
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`© 2006, The Association for Research in Vision and Ophthalmology, Inc., all rights reserved.
`Permission to republish any abstract or part of an abstract in any form must be obtained in
`writing from the ARVO Office prior to publication.
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