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This material may be protected by Copyright law (Title 17 U.S. Code)
`
`FREE
`ARVO Annual Meeting Abstract I May 2005
`
`Microbiology Assessment of a Multi -Dose
`Preservative Free Tear Product
`
`R.P. Stone' R.A. Rosenthal; S.L. Buck. B.A. Schlech
`+ Author Affiliations & Notes
`
`Investigative Ophthalmology & Visual Science May 2005, Vo1.46, 2041. doi:
`
`Abstract
`Abstract: : Purpose:Preservatives are added to products to prevent contamination. Multi -
`dose products are required to meet preservative efficacy standards. But sometimes these
`useful preservatives cause irratation to the eye, and a preservative -free product may be
`desirable. A new preservative free product in a multi -dose container (MDPF product) was
`developed to meet these needs. The purpose of this study was to show that a new
`preservative free product is capable of controlling and preventing contamination under
`extreme microbial conditions. Methods:The new preservative free product was repeatedly
`challenged with Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli,
`Candida albicans and Aspergillus niger throughout a 6 -month period. Additionally,
`multiple lots of the new formulation were stored at elevated and room temperatures for
`over 6 months. Results:The results consistently showed that the new product is capable of
`preventing contamination of the product. The new product showed greater than a 3 log
`reduction of the challenge bacteria. Conclusions:Though the MDPF product contains no
`preservatives, it is formulated with a unique blend of ingredients that allow it to maintain
`efficacy when exposed to extreme microbial conditions.
`
`Keywords: cornea: tears /tear film /dry eye bacterial disease
`
`fungal disease
`
`© 2005, The Association for Research in Vision and Ophthalmology, Inc., all rights reserved.
`Permission to republi's'h any abstract or part of an abstract in any form must be obtained in
`writing from the ARVO Office prior to publication.
`Exhibit 1043
`ARGENTUM
`IPR2017-01053
`
`000001
`
`

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