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Roya N. Borazjani, M.S., Ph.D. Alcon Laboratories, Inc. FDA Workshop January 2009

Outline. Current FDA/ISO Tests (In Vitro)Stand-Alone RegimenPotential Enhancement of Current Antimicrobial Efficacy TestingAntimicrobial Efficacy Endpoint Test (Current ANSI Ring Test)Proposed Flow Chart of Testing for Acanthamoeba spp.. 1- Stand-Alone: Qualifies individual solutions with antimicrobial activity as contact lens disinfecting products (Planktonic, No lens) .

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Roya N. Borazjani, M.S., Ph.D. Alcon Laboratories, Inc. FDA Workshop January 2009

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    1. Roya N. Borazjani, M.S., Ph.D. Alcon Laboratories, Inc. FDA Workshop January 2009

    2. Outline Current FDA/ISO Tests (In Vitro) Stand-Alone Regimen Potential Enhancement of Current Antimicrobial Efficacy Testing Antimicrobial Efficacy Endpoint Test (Current ANSI Ring Test) Proposed Flow Chart of Testing for Acanthamoeba spp.

    4.

    5. Potential Enhancements of Current Antimicrobial Efficacy Testing Prolonged Storage Time Disinfection Uptake and Release Contact Lens Contact Cases Microbial Attachment Contact Lens Contact Cases Soiled Lens and Contaminated Lens Cases

    8. Combination Effect of Organic Load and Storage Time on Disinfection Efficacy

    9. Anti-fungal Activity of Multi Purpose Solutions Against Fusarium solani (n=3) Rosenthal et al (2006) Eye & Contact Lens; 32:1-5

    10. Percent Biocide in Products after “Used” with a Hydrogel Lens

    11. AEEMC Test: Qualifies the efficacy of individual solutions in the presence of contact lenses and organic soil in the contact case up to 30 days

    13. Additional Factors That Effects Antimicrobial Activities of CL Care Products Prolonged Storage Time Disinfection Uptake and Release Contact Lens Cases Soiled Lens and Contaminated Lens Cases Microbial Adhesion CL CL cases Lens and Lens Case Material Disinfection Time Clinical Isolates Organic Soil Components Concentration Steps or order of addition Lens Case Volume Solution Efficacy

    14. Additional Factors That Effects Antimicrobial Activities of CL Care Products Prolonged Storage Time Disinfection Uptake and Release Contact Lens Cases Soiled Lens and Contaminated Lens Cases Microbial Adhesion CL CL cases Lens and Lens Case Material Disinfection Time Clinical Isolates Organic Soil Components Concentration Steps or order of addition Lens Case Volume Solution Efficacy

    15. Various Marketed SiHy Contact Lens

    16. CL Material and Differences in Properties Oxygen permeability/transmissibility Hydrophobic characteristics (wettability, coefficient of friction, dehyration, dryness, discomfort) Various Packaging solutions Elastomeric properties (modulus, stiffness, lens adhesion) Lens Groups (ionicity, water content) Chemical composition of material surfaces (silicone, nitrogen, oxygen, other) Polymer, monomers and manufacturing processes Surface Modifications Various uptake and release Kinetics Deposition profile (Protein, Lipid, microorganisms)

    17. Additional Factors That Effects Antimicrobial Activities of CL Care Products Prolonged Storage Time Disinfection Uptake and Release Contact Lens Cases Soiled Lens and Contaminated Lens Cases Microbial Adhesion CL CL cases Lens and Lens Case Material Disinfection Time Clinical Isolates Organic Soil Components Concentration Steps or order of addition Lens Case Volume Solution Efficacy

    18. Effect of Storage Time on Disinfection Efficacy of MPS against F. solani

    19. Additional Factors That Effects Antimicrobial Activities of CL Care Products Prolonged Storage Time Disinfection Uptake and Release Contact Lens Cases Soiled Lens and Contaminated Lens Cases Microbial Adhesion CL CL cases Lens and Lens Case Material Disinfection Time Clinical Non-ATCC Isolates ?? Organic Soil Components Concentration Steps or order of addition Lens Case Volume Solution Efficacy (against Acanthamoeba Spp.)

    20. Proposed Flow Chart of Testing for Acanthamoeba

    21. Conclusions The Design of the Next Generation Antimicrobial Efficacy Testing is Critical for the Next Generation Contact Lenses and Contact Lens Care Solutions

    22. What does it take to clean a contaminated lens case

    23. Alcon Team Ron Schlitzer, Ph.D. Megan Callan Cindy McAnally Ruth Ann Rosenthal, M.S. Sudha Neelam, M.S. Sally Buck Linda McNamee Rhonda Walters Sara Nugyuam

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