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H. Sheardown, L. Liu; Embedded Wetting Agent Release from 1-Day Acuvue® TruEyeTM Lenses. Invest. Ophthalmol. Vis. Sci. 2009;50(13):5654.
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1-Day Acuvue® TruEyeTM (J&J Vision Care, USA) (AT) is the first silicone hydrogel daily disposable soft contact lenses. The silicone hydrogel component is combined with a moisture-rich ingredient based on polyvinyl pyrrolidone (PVP) as an internal wetting agent, using the proprietary Hydraclear 1TM technology. The purpose of this study was to examine the properties of these lenses and to assess whether the embedded wetting agent remains in the lens or is released into the surrounding ocular environment.
Lenses were removed from their packaging solutions and placed in PBS at 35oC. Releasate was collected at regular intervals. The release solutions were analyzed for PVP using a variety of methods, including UV spectrophotometry, gel permeation chromatography, FTIR and mass spectroscopy to assess whether the wetting agent was released and to quantify any such release. Analyses of the packing solutions were also performed for comparison. The lens properties were examined by measuring water contact angles (CA) over time to assess changes in the surface hydrophilicity and surface chemistry, as a function of PBS exposure.
All analytical results for the releasates demonstrate that the embedded PVP wetting is not released from the lens at any time during a during a simulated wear period of 15 hours. The FTIR spectrum showed no peak consistent with the molecular fingerprint of the wetting agent and gel permeation chromatography results showed no high molecular weight peaks. All low molecular weight peaks were consistent with components of the packaging solution. CA results showed little variation over a simulated wear period of 15 hours suggesting that the properties of the lenses are not altered by PBS exposure.
AT lenses contain an internal wetting agent that is not released in measurable quantities in PBS over a simulated wear period of 15 hours. The properties of these lenses were stable over the period of wear.
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