Public Workshop ? Revamping Microbiological Test Methods for Contact Lenses, Products and Accessories to Protect Health and Ensure Safety, September 12, 2014


Date, Time and Location

  • Federal Register Notice
  • Agenda
  • Registration
  • Contact Us

  • FDA Campus Information

    The meeting will be webcasted.

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    Agenda

    8:00am-8:05amWelcome Goals – Food and Drug Administration (FDA)Malvina Eydelman, MD8:05am-8:10amWelcome – American Academy of Ophthalmology (AAO)Thomas Steinemann, MD8:10am-8:15amWelcome – American Academy of Optometry (AAOpt)Loretta Szczotka-Flynn, OD8:15am-8:20amWelcome – American Optometric Association (AOA)Joseph Shovlin, OD8:20am-8:25amWelcome – Contact Lens Association of Ophthalmologists (CLAO)Deborah Jacobs, MD8:25am-8:35amRegulation of Contact Lenses and Associated Care ProductsDenise Hampton, PhD (FDA)8:35am-8:45amPreclinical Test Methods for Contact Lenses and their Care ProductsJeffrey Brocious, MS (FDA)8:45am-8:55amHistory Rationale for the Panel of Test Organisms for Contact Lens Care ProductsRalph Stone, PhD

    Panel 1: Emerging Pathogens in Contact Lens-Related Keratitis

    ModeratorLoretta Szczotka-Flynn, OD (AAO)PANELISTSSuzi Fleiszig, OD, PhD, Michelle Callegan, PhD, Michael Gilmore, PhD, Mark Willcox, PhD, Eduardo Alfonso, MD, Jennifer Cope, MD, MPH (CDC), Jonathan Yoder, PhD (CDC), Elmer Tu, MD, John Dart, MD8:55am-9:10amCauses of Contact Lens-Related Infectious Keratitis in the U.S.: Historical Trends and Emerging PathogensJonathan Yoder, PhD (CDC)9:10am-9:25amInternational Patterns of Contact Lens- Related Infectious KeratitisJohn Dart, MD9:25am-9:40amImpact of Changing Water Restrictions on Contact Lens-Related Infectious KeratitisElmer Tu, MD9:40am-10:40amPanel Discussion Question #110:40am-10:55amBreak

    Panel 2: Role of Soil in Disinfection Efficacy Testing

    Moderator Michael Duenas, OD (AOA)PANELISTSCarol Lakkis, PhD, Suzi Fleiszig, OD, PhD, Michelle Callegan, PhD, Michael Gilmore, PhD, Mark Willcox, PhD, Ralph Stone, PhD10:55am-11:10am 
      Definition of Organic Soil and the Relevant Components of an Artificial Tear Model Mark Willcox, PhD11:10am-11:25amIncorporating Soil in the Preclinical Testing of Contact Lenses and their Products: Historical Perspective Current MethodsScott Steffen, PhD (FDA)11:25am-11:40amMeasuring the Efficacy of Organic Soil RemovalJoseph Hutter, PhD (FDA)11:40am-12:40pmPanel Discussion Question #212:40pm-1:40pmLUNCH

    Panel 3: Acanthamoeba:  The Organism and Test Methods

    Moderator Deepinder Dhaliwal, MD (CLAO)PANELISTSDonald Ahearn, PhD, Simon Kilvington, PhD, Elmer Tu, MD, Ralph Stone, PhD, Mary Mowrey-McKee, PhD1:40pm-1:55pmAcanthamoeba Keratitis: Biology of the Organism and Host FactorsDonald Ahearn, PhD1:55pm-2:10pmDisinfection Efficacy Test Methods for AcanthamoebaDaniel Fedorko, PhD (FDA)2:10pm-2:25pm Disinfection Efficacy Test Methods for AcanthamoebaSimon Kilvington, PhD2:25pm-4:25pmPanel Discussion Questions #3-54:25pm-5:00pmClosing RemarksCLAODeepinder Dhaliwal, MDAOAJoseph Shovlin, ODAAOpLoretta Szczotka-Flynn, ODAAOThomas Steinemann, MDFDAMalvina Eydelman, MD5:00pmADJOURN

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    Registration to Attend the Workshop:

    To register for the public workshop, please visit http://www.clwkshop.org. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone number. If there are any questions with registration, please contact Ms. Cindy Groff at [email protected]. Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list.

    Registration is $250 for members of the American Academy of Ophthalmology (AAO), American Academy of Optometry (AAOpt), American Optometric Association(AOA), or Contact Lens Association of Ophthalmologists, Inc. (CLAO); or $400 for non-members and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online. The deadline for online registration is September 5, 2014 at 4:00 PM EDT. There will be no onsite registration on the day of the public workshop.

    If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communications, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5661, [email protected].

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    [email protected].

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