Public Workshop – Revamping Microbiological Test Methods for Contact Lenses, Products and Accessories to Protect Health and Ensure Safety, September 12, 2014.
The Food and Drug Administration (FDA), American Academy of Ophthalmology (AAO), American Academy of Optometry (AAOpt), American Optometric Association (AOA), and Contact Lens Association of Ophthalmologists, Inc. (CLAO) are co-sponsoring the following workshop entitled “Revamping Microbiological Test Methods for Contact Lenses, Products and Accessories to Protect Health and Ensure Safety.” The purpose of this workshop is to discuss adequate testing of contact lens care products for disinfection efficacy against emerging pathogens as well as common infectious etiologies.
Date, Time and Location:
This meeting will be held September 12, 2014, beginning at 8:00 am – 5:00 pm at the following location:
FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993
The meeting will be webcasted.
|8:00am-8:05am||Welcome & Goals – Food and Drug Administration (FDA)||Malvina Eydelman, MD|
|8:05am-8:10am||Welcome – American Academy of Ophthalmology (AAO)||Thomas Steinemann, MD|
|8:10am-8:15am||Welcome – American Academy of Optometry (AAOpt)||Loretta Szczotka-Flynn, OD|
|8:15am-8:20am||Welcome – American Optometric Association (AOA)||Joseph Shovlin, OD|
|8:20am-8:25am||Welcome – Contact Lens Association of Ophthalmologists (CLAO)||Deborah Jacobs, MD|
|8:25am-8:35am||Regulation of Contact Lenses and Associated Care Products||Denise Hampton, PhD (FDA)|
|8:35am-8:45am||Preclinical Test Methods for Contact Lenses and their Care Products||Jeffrey Brocious, MS (FDA)|
|8:45am-8:55am||History & Rationale for the Panel of Test Organisms for Contact Lens Care Products||Ralph Stone, PhD|
Panel 1: Emerging Pathogens in Contact Lens-Related Keratitis
|Moderator||Loretta Szczotka-Flynn, OD (AAO)|
|PANELISTS||Suzi 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, MD|
|8:55am-9:10am||Causes of Contact Lens-Related Infectious Keratitis in the U.S.: Historical Trends and Emerging Pathogens||Jonathan Yoder, PhD (CDC)|
|9:10am-9:25am||International Patterns of Contact Lens- Related Infectious Keratitis||John Dart, MD|
|9:25am-9:40am||Impact of Changing Water Restrictions on Contact Lens-Related Infectious Keratitis||Elmer Tu, MD|
|9:40am-10:40am||Panel Discussion Question #1|
Panel 2: Role of Soil in Disinfection Efficacy Testing
|Moderator||Michael Duenas, OD (AOA)|
|PANELISTS||Carol Lakkis, PhD, Suzi Fleiszig, OD, PhD, Michelle Callegan, PhD, Michael Gilmore, PhD, Mark Willcox, PhD, Ralph Stone, PhD|
|10:55am-11:10am ||Definition of Organic Soil and the Relevant Components of an Artificial Tear Model||Mark Willcox, PhD|
|11:10am-11:25am||Incorporating Soil in the Preclinical Testing of Contact Lenses and their Products: Historical Perspective & Current Methods||Scott Steffen, PhD (FDA)|
|11:25am-11:40am||Measuring the Efficacy of Organic Soil Removal||Joseph Hutter, PhD (FDA)|
|11:40am-12:40pm||Panel Discussion Question #2|
Panel 3: Acanthamoeba: The Organism and Test Methods
|Moderator||Deepinder Dhaliwal, MD (CLAO)|
|PANELISTS||Donald Ahearn, PhD, Simon Kilvington, PhD, Elmer Tu, MD, Ralph Stone, PhD, Mary Mowrey-McKee, PhD|
|1:40pm-1:55pm||Acanthamoeba Keratitis: Biology of the Organism and Host Factors||Donald Ahearn, PhD|
|1:55pm-2:10pm||Disinfection Efficacy Test Methods for Acanthamoeba||Daniel Fedorko, PhD (FDA)|
|2:10pm-2:25pm||Disinfection Efficacy Test Methods for Acanthamoeba||Simon Kilvington, PhD|
|2:25pm-4:25pm||Panel Discussion Questions #3-5|
|CLAO||Deepinder Dhaliwal, MD|
|AOA||Joseph Shovlin, OD|
|AAOp||Loretta Szczotka-Flynn, OD|
|AAO||Thomas Steinemann, MD|
|FDA||Malvina Eydelman, MD|
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 firstname.lastname@example.org. 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@example.com.
For questions regarding workshop content please contact:
Jeffrey Brocious, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, Phone: 240-402-3797, email: Jeffrey.Brocious@fda.hhs.gov.