Disinfection Efficacy Test Methods for Contact Lens Care Products An Overview of Where We Are and Wh

1
Disinfection Efficacy Test Methods for Contact
Lens Care Products - An Overview of Where We Are
and Where We Want To Go

• Susan Norton
• Director, RD Microbiology and Sterilization
  Sciences
• Bausch Lomb

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Disinfection Efficacy Test Methods

• Background
• Existing standards, guidance
• More complex solutions and lens chemistries
• Recent history two product withdrawals
• What additional test methodologies should be
  considered

3
Options

• Consider modifications of acceptance criteria
• Add to arsenal of testing
• Consider misuse conditions

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Supplemental Testing

• Requires manufacturer to understand product
  formula, potential consumer behavior patterns,
  and impact of these behaviors upon product
  performance
• Consider interactions of formulation components,
  primary packaging, lenses and cases

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Supplemental testing

• Impact of existing and new methodologies upon
  product development
• Impact of potential misuse/abuse of system by
  consumer upon product performance
• Cycling/re-use studies
• Evaporation studies
• Studies to evaluate unique properties of
  formulation
• Clinical isolates
• Lens/case/solution impact upon efficacy
• Acanthamoeba testing

6
Supplemental Testing

• Benefits
• Develop more data for product development program
• Better understanding of product performance under
  a variety of possible misuse conditions
• Generation of a more complete comparative data
  portfolio

7
Supplemental Testing

• Disadvantages
• Lack of well-characterized methods
• Difficult to interpret in absence of defined
  industry standards/acceptance criteria
• Impact to product development cycle time

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Supplemental Testing - Next Steps

• Interpretation of data
• Benchmark against standardized test/control
  article(s)
• Include products/formulations with known
  correlation between consumer practices and impact
  on disinfection efficacy

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Supplemental Testing

• Industry is working together
• AEEMC standard development
• Acanthamoeba testing
• Industry working with regulatory agencies
• New methods expected to enhance overall product
  performance by providing additional data on
  disinfection efficacy under a variety of
  conditions