Newsroom
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Also Adds FDA Claim That it Conditions Lenses
FOR RELEASE TUESDAY, NOVEMBER
29, 2005
ROCHESTER, N.Y. - The U.S. Food and Drug Administration has cleared
additional labeling claims for Bausch & Lomb ReNu® with
MoistureLoc® Multi-Purpose Solution (MPS). FDA cleared labeling that
includes a specific indication for ReNu with MoistureLoc solution
use with silicone hydrogel contact lenses, and an additional claim that the
product conditions contact lenses, in support of its original "sustained
comfort" labeling claim.
"While ReNu with MoistureLoc solution has always been approved for use with soft contact lenses, including silicone hydrogel lenses, Bausch & Lomb, in recognizing the accelerating growth of silicone hydrogels, pursued the specific labeling claim to further clarify and underscore the appropriate uses of the product," said Gerard Warner, Bausch & Lomb director - Lens Care Marketing.
Clinical data submitted to FDA in support of the claim included a clinical evaluation of ReNu with MoistureLoc MPS when used with a variety of silicone hydrogel lenses. Seventeen practitioners in the United States monitored 400 patients in a cross-over study comparing clinical outcomes between ReNu with MoistureLoc solution and a competitive lens care regimen when used in combination with Bausch & Lomb PureVision TM silicone hydrogel lenses, and silicone hydrogel lenses from Ciba Vision and Vistakon.
Practitioners reported that ReNu with MoistureLoc MPS in combination with silicone hydrogel contact lenses delivers excellent eye health. Patients reported that ReNu with MoistureLoc solution provided superior comfort and significantly less dryness.
"As our clinical data show, ReNu with MoistureLoc solution is compatible, safe and effective with silicone hydrogel contact lenses. In fact, our most recent silicone hydrogel clinical data demonstrates that ReNu with MoistureLoc solution has superior overall comfort, end-of-day comfort and comfort upon insertion compared to Opti-Free Express," said Jeffrey Nardoci, Bausch & Lomb vice president - Marketing, U.S. Vision Care.
ReNu with MoistureLoc is the first multi-purpose solution that may improve comfort in patients experiencing contact lens dryness. No other product has this action described in its cleared labeling. The patented ReNu with MoistureLoc formula delivers sustained comfort and resists protein uptake while providing excellent disinfection for soft contact lenses, including silicone hydrogel lenses.
