* Compared to Clear Care

  1. Results from a 22 investigator, multi-site study of PeroxiClear, with a total of 440 eligible subjects. Subjects were randomized to use either PeroxiClear or Clear Care for 3 months. Subjects completed performance surveys at 2-week, 1-month, 2-month, and 3-month visits.

  2. Results from a 21-investigator, multi-site study of PeroxiClear, with a total of 297 eligible subjects who were habitual Clear Care users. After 7 days of use, subjects completed an online survey. Consumers rated the performance ofPeroxiClear across a range of attributes and compared the performance to their habitual Clear Care solution.

  3. High-resolution/accurate-mass (HR/AM) mass spectrometry was used to detect and quantitate the relative amounts of surfactant retained on lenses from PeroxiClear and Clear Care solutions after 20 hours of wear. PureVision2, ACUVUE OASYS and AIR OPTIX AQUA lenses were soaked in solutions for 12 hours prior to patients wearing lenses for 20 hours.

  4. Results of an ex vivo study measuring deposits on worn contact lenses to compare the clinical performance ofPeroxiClear and Clear Care solutions. Lenses were worn daily for 1 month (silicone hydrogel and Group IV hydrogel lenses) or 3 months (gas permeable lenses). A total of 374 lenses were randomly selected for image analysis. Lenses were scored for mean density of deposits and percent coverage of deposits.

  5. Results of an in vitro study measuring deposits on ACUVUE OASYS lenses. Lenses were subjected to 14 cycles of deposition with a lipid and protein solution mimicking the human tear flm followed by a cleaning regimen with eitherPeroxiClear or Clear Care 3% hydrogen peroxide systems. Each deposition/cleaning cycle was representative of one day of patient use. Cycled lenses (n=3) were analyzed for deposits using image analysis. After 14 cycles, lenses cleaned with PeroxiClear had only 8.0% surface coverage compared to 33.0% for lenses cleaned with Clear Care.

  6. Results of in vitro study following FDA/ISO stand-alone procedure for disinfecting products. Test solutions were modified with organic soil to create a more rigorous test condition. Primary criteria for effective disinfection are defined as a reduction in the number of bacteria by a minimum of 3 logs (99.9%) and a reduction of mold and yeast by a minimum of 1 log (90%) within the recommended disinfection time.


US/OCD/14/0043