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ECC Care Systems
                                                     •   Study package inserts!
                                                     •   Abbott RevitaLens
                                                     •   Alcon OPTI-FREE PureMoist
        Soft Contact Lens Care
                                                     •   Bausch + Lomb Biotrue
       Systems and Compliance
                                                     •   Bausch + Lomb Renu fresh
            Eunice Myung Lee, O.D., FAAO
                     April 2012                      •   CIBA VISION (Alcon) Clear Care
         CLS671 – Cornea & Contact Lenses II         •   CIBA VISION (Alcon) AQuify




       ECC Care Systems – Pt ed                                                MPS
• Purpose of each step                               • Preservatives
• Why is it important?                               • Unique products
• Neutralization of H2O2




            MPS - Preservatives                                   MPS - Preservatives
• Thimerosal (0.002%)
  – Mercurial antibacterial                               • Benzalkonium Chloride (BAK)
  – Effective against gram + bacteria                       – Cytotoxic to corneal epithelium
                                                            – May be in ocular medications
  – CYTOTOXIC to corneal epithelium
     • May lead to Type IV hypersensitivity
                                                          • Sorbic Acid = Potassium Sorbate
                                                            – Turns methafilcon lenses yellow
                                                              (CooperVision Hydrasoft)
  – No longer used with SCLs, but may be in ocular
                                                          • Dymed & Polyquad
    medications
                                                            – Newer
                                                            – Larger molecule size to decrease toxicity
MPS – Unique Products                       RevitaLens OcuTec MPDS
•   New(est) kids on the block                • Surfactant for lubrication
•   Abbott RevitaLens                         • EDTA (chelant)
•   Alcon OPTI-FREE PureMoist                   – Decreases deposit formation
•   Bausch + Lomb Biotrue                       – Adds antimicrobial properties




      OPTI-FREE PureMoist MPDS                                    Biotrue MPS
• EDTA                                         • Matches pH of tears
• Wetting agent – EOBO (HydraGlyde)            • Natural lubricant (similar to tears)
                                               • Keeps beneficial tear proteins alive
    – Reduces hydrophobicity of SiHy lenses
    – Reduces LIPID deposits




                Other products                       Enzyme (Protein) Cleaners
• Rewetting drops
• Enzymatic cleaners
• Protein cleaners                                                NO           YES


                                              Daily              2 wk   1 mo     >1 mo
                                              Disposable         Repl       Repl         Repl

                                                                                         Heavy coater
                                                                                         GPC
FDA – Current Review Process                  FDA – Current Review Process
• Reviews Safety and Efficacy                 • Challenge Microorganisms
• Stand alone test                              – Staphylococcus aureus & epidermidis (gram +
                                                  cocci)
• Regimen test
                                                – Serratia marcescens (gram – rod)
                                                – Pseudomonas aeruginosa (gram – rod)
                                                – Candida albicans (yeast)
                                                – Fusarium solani (fungus)




         FDA – What’s to come                             A Few Bad Years!
• Acanthamoeba trophozoites & cysts           • Fall 2005 – CIBA VISION discontinues all lens
• New lens group                                care products
• New tests – “real world” scenarios          • Summer 2006 – B&L recalls ReNu MoistureLoc
                                              • Fall 2006 – AMO recalls Complete Moisture
• Aug 2010 – reaffirmed rub & rinse regimen     Plus
                                              • Winter 2006 – B&L recall of ReNu MultiPlus




            Fusarium Keratitis                            Fusarium Keratitis
• Fungal                                      • May be misdiagnosed as bacterial microbial
• Can’t penetrate intact cornea                 keratitis
• Symptoms                                    • Filamentous, irregular borders; elevated, dirty
  – Redness                                     grey
  – Blurred vision
  – Tearing
  – Excessive discharge
  – Sensitivity to light
How Did It Happen?                                              Biofilm
• Newer, larger molecules coated the lenses         • “a microbial community”
• Some molecules released from SiHy lenses          • Can aid in bacterial adhesion & colonization;
• Fungal keratitis – less than 1 in 1,000,000 per     secretes substances that act as scaffold
  year                                              • May contain multiple species of organisms;
• Microbial keratitis – 4-21 per 10,000 in SCL        can render resistance to biocidal properties of
  wearers (higher in overnight lens use)              lens care products
• Biofilm




         Acanthamoeba Keratitis                                          Lens Cases
• Tap water - water treatment facilities            •   Cleaning?
    – EPA reduction of chlorine                     •   Additional antimicrobials
    – Distance from treatment facility              •   Replacement?
• Swimming, Hot tub                                 •   Reminder systems
• Trophozoite vs cysts
• 1 in 30,000 hydrogel wearers




            Lens Cases - Cleaning                          Lens Cases - Antimicrobials
•   Tap water? Saline? MPS? H2O2?                   – Impregnated with silver ions

•   Rub? Soap? Dishwasher?                          • CIBA VISION PRO-GUARD case
                                                        – Significant reduction of challenge microorganisms
•   Tissue wipe?
                                                        – Silver gradually released as case exposed to
•   Air dry? Positioning?                                 moisture
•   Where?                                          • Amcon Laboratories I-clean case
                                                    • Brien Holden Vision Institute
                                                        – Antimicrobial material to coat cases – in progress
Lens Cases - Replacement                          Lens Cases - Reminders
• Regularly. Monthly? Every 3 months? 6         • LensAlert (Watch Dog Group LC)
  months?                                         – # days replace lenses
                                                  – # days replace case
                                                • With every bottle?




                Compliance                                      Handwashing
• “the extent to which a patient’s behavior     • Correct process?
  coincides with the clinical prescription” –     – Soap & water
  Sackett & Hayes 1976                            – Antimicrobial hand sanitizers – contain alcohol
• Reported range of noncompliance with          • Harris Interactive Poll (2005)
  medical instructions of 8 to 92%                – Compliance after public restroom usage
                                                  – 95% women, 75% men
                                                • Failure to wash hands prior to lens handling –
                                                  1.49x increased risk MK (Dart, 2008)




           Handwashing Help                                      Hand Drying
• The Centers for Disease Control and           • Paper towel –slight decrease in bacterial load
  Prevention – Clean Hands Campaign               – Lint free – good for CL care
• Wash hands with soap & water for 20 secs =    • Hot air drying – increases bacterial load
  time to sing “Happy Birthday” twice
• Warm water – better solvent than cold
Compliance – CL Patients                               Compliance – CL Patients
• PubMed search “compliance” + “contact               • 26% of soft contact lens patients were fully
  lenses”                                               compliant with lens care and maintenance
  – 163 refereed papers                                 (Collins & Carney, 1986)
  – Numerous non-peer reviewed                        • Virtually all non-compliant with at least 1
  – First relevant reference – JF Morgan, 1979          required procedure (Turner et al, 1993)
  – First relevant study – Collins & Carney, 1986     • 24% never cleaned lenses before disinfection,
                                                        5% used saline to “disinfect” (Ky et al, 1998)




                 Instructions                                AOA/AAO CL Sections Pt Ed
• 79% admitted non-compliance in some area of         •   Wash hands prior to lens handling
  CL care (De Oliveira et al, 2003)                   •   Rub lenses
• 0.3% compliant with 14 steps required               •   Don’t top off solutions
  (Morgan, 2007)                                      •   Clean & regularly replace cases
• Full compliance very rare (Morgan et al, 2011)      •   D/C lens wear & immediately contact ECP if
• Improves by explaining benefits of compliant            symptoms of pain, blurred vision, redness,
  procedures (McMonnies, 2011)                            increased tearing/photophobia




          Building Compliance                                           Oh Great!!
• “Prescribe”, not recommend                          • “Patients are often lying when they say they
  – Write on an Rx pad                                  have regularly taken the prescribed medicine”
  – Provide detailed written handout WITH soln name     – Hippocrates, 400 BC
• Dispense complimentary starter kits
• Review advantages of product
• “If you deviate from this solution, you run the
  risk of compromising comfortable, long-term
  wear”
• COMMUNICATION! Consistent message.
Problems             Care System Identification
•   Generics                    •   48% brand name MPS
•   Saline                      •   9% H2O2
•   Rub vs. No-Rub              •   3.5% generic
•   Staining                    •   40% unsure
•   Product confusion           •   Product pictures help




                 Other Issues
•   Daily disposable wearers
•   Part-time wearers
•   Silicone Hydrogel
•   Piggyback/hybrid lenses
•   Swimming

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2012 scl care_system_hour2

  • 1. ECC Care Systems • Study package inserts! • Abbott RevitaLens • Alcon OPTI-FREE PureMoist Soft Contact Lens Care • Bausch + Lomb Biotrue Systems and Compliance • Bausch + Lomb Renu fresh Eunice Myung Lee, O.D., FAAO April 2012 • CIBA VISION (Alcon) Clear Care CLS671 – Cornea & Contact Lenses II • CIBA VISION (Alcon) AQuify ECC Care Systems – Pt ed MPS • Purpose of each step • Preservatives • Why is it important? • Unique products • Neutralization of H2O2 MPS - Preservatives MPS - Preservatives • Thimerosal (0.002%) – Mercurial antibacterial • Benzalkonium Chloride (BAK) – Effective against gram + bacteria – Cytotoxic to corneal epithelium – May be in ocular medications – CYTOTOXIC to corneal epithelium • May lead to Type IV hypersensitivity • Sorbic Acid = Potassium Sorbate – Turns methafilcon lenses yellow (CooperVision Hydrasoft) – No longer used with SCLs, but may be in ocular • Dymed & Polyquad medications – Newer – Larger molecule size to decrease toxicity
  • 2. MPS – Unique Products RevitaLens OcuTec MPDS • New(est) kids on the block • Surfactant for lubrication • Abbott RevitaLens • EDTA (chelant) • Alcon OPTI-FREE PureMoist – Decreases deposit formation • Bausch + Lomb Biotrue – Adds antimicrobial properties OPTI-FREE PureMoist MPDS Biotrue MPS • EDTA • Matches pH of tears • Wetting agent – EOBO (HydraGlyde) • Natural lubricant (similar to tears) • Keeps beneficial tear proteins alive – Reduces hydrophobicity of SiHy lenses – Reduces LIPID deposits Other products Enzyme (Protein) Cleaners • Rewetting drops • Enzymatic cleaners • Protein cleaners NO YES Daily 2 wk 1 mo >1 mo Disposable Repl Repl Repl Heavy coater GPC
  • 3. FDA – Current Review Process FDA – Current Review Process • Reviews Safety and Efficacy • Challenge Microorganisms • Stand alone test – Staphylococcus aureus & epidermidis (gram + cocci) • Regimen test – Serratia marcescens (gram – rod) – Pseudomonas aeruginosa (gram – rod) – Candida albicans (yeast) – Fusarium solani (fungus) FDA – What’s to come A Few Bad Years! • Acanthamoeba trophozoites & cysts • Fall 2005 – CIBA VISION discontinues all lens • New lens group care products • New tests – “real world” scenarios • Summer 2006 – B&L recalls ReNu MoistureLoc • Fall 2006 – AMO recalls Complete Moisture • Aug 2010 – reaffirmed rub & rinse regimen Plus • Winter 2006 – B&L recall of ReNu MultiPlus Fusarium Keratitis Fusarium Keratitis • Fungal • May be misdiagnosed as bacterial microbial • Can’t penetrate intact cornea keratitis • Symptoms • Filamentous, irregular borders; elevated, dirty – Redness grey – Blurred vision – Tearing – Excessive discharge – Sensitivity to light
  • 4. How Did It Happen? Biofilm • Newer, larger molecules coated the lenses • “a microbial community” • Some molecules released from SiHy lenses • Can aid in bacterial adhesion & colonization; • Fungal keratitis – less than 1 in 1,000,000 per secretes substances that act as scaffold year • May contain multiple species of organisms; • Microbial keratitis – 4-21 per 10,000 in SCL can render resistance to biocidal properties of wearers (higher in overnight lens use) lens care products • Biofilm Acanthamoeba Keratitis Lens Cases • Tap water - water treatment facilities • Cleaning? – EPA reduction of chlorine • Additional antimicrobials – Distance from treatment facility • Replacement? • Swimming, Hot tub • Reminder systems • Trophozoite vs cysts • 1 in 30,000 hydrogel wearers Lens Cases - Cleaning Lens Cases - Antimicrobials • Tap water? Saline? MPS? H2O2? – Impregnated with silver ions • Rub? Soap? Dishwasher? • CIBA VISION PRO-GUARD case – Significant reduction of challenge microorganisms • Tissue wipe? – Silver gradually released as case exposed to • Air dry? Positioning? moisture • Where? • Amcon Laboratories I-clean case • Brien Holden Vision Institute – Antimicrobial material to coat cases – in progress
  • 5. Lens Cases - Replacement Lens Cases - Reminders • Regularly. Monthly? Every 3 months? 6 • LensAlert (Watch Dog Group LC) months? – # days replace lenses – # days replace case • With every bottle? Compliance Handwashing • “the extent to which a patient’s behavior • Correct process? coincides with the clinical prescription” – – Soap & water Sackett & Hayes 1976 – Antimicrobial hand sanitizers – contain alcohol • Reported range of noncompliance with • Harris Interactive Poll (2005) medical instructions of 8 to 92% – Compliance after public restroom usage – 95% women, 75% men • Failure to wash hands prior to lens handling – 1.49x increased risk MK (Dart, 2008) Handwashing Help Hand Drying • The Centers for Disease Control and • Paper towel –slight decrease in bacterial load Prevention – Clean Hands Campaign – Lint free – good for CL care • Wash hands with soap & water for 20 secs = • Hot air drying – increases bacterial load time to sing “Happy Birthday” twice • Warm water – better solvent than cold
  • 6. Compliance – CL Patients Compliance – CL Patients • PubMed search “compliance” + “contact • 26% of soft contact lens patients were fully lenses” compliant with lens care and maintenance – 163 refereed papers (Collins & Carney, 1986) – Numerous non-peer reviewed • Virtually all non-compliant with at least 1 – First relevant reference – JF Morgan, 1979 required procedure (Turner et al, 1993) – First relevant study – Collins & Carney, 1986 • 24% never cleaned lenses before disinfection, 5% used saline to “disinfect” (Ky et al, 1998) Instructions AOA/AAO CL Sections Pt Ed • 79% admitted non-compliance in some area of • Wash hands prior to lens handling CL care (De Oliveira et al, 2003) • Rub lenses • 0.3% compliant with 14 steps required • Don’t top off solutions (Morgan, 2007) • Clean & regularly replace cases • Full compliance very rare (Morgan et al, 2011) • D/C lens wear & immediately contact ECP if • Improves by explaining benefits of compliant symptoms of pain, blurred vision, redness, procedures (McMonnies, 2011) increased tearing/photophobia Building Compliance Oh Great!! • “Prescribe”, not recommend • “Patients are often lying when they say they – Write on an Rx pad have regularly taken the prescribed medicine” – Provide detailed written handout WITH soln name – Hippocrates, 400 BC • Dispense complimentary starter kits • Review advantages of product • “If you deviate from this solution, you run the risk of compromising comfortable, long-term wear” • COMMUNICATION! Consistent message.
  • 7. Problems Care System Identification • Generics • 48% brand name MPS • Saline • 9% H2O2 • Rub vs. No-Rub • 3.5% generic • Staining • 40% unsure • Product confusion • Product pictures help Other Issues • Daily disposable wearers • Part-time wearers • Silicone Hydrogel • Piggyback/hybrid lenses • Swimming