240 likes | 767 Vues
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) .
E N D
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