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