Soft Contact Lens Care

Systems and ComplianceEunice Myung Lee, O.D., FAAO

April 2012

CLS671 – Cornea & Contact Lenses II

ECC Care Systems

• Study package inserts!

• Abbott RevitaLens

• Alcon OPTI-FREE PureMoist

• Bausch + Lomb Biotrue

• Bausch + Lomb Renu fresh

• CIBA VISION (Alcon) Clear Care

• CIBA VISION (Alcon) AQuify

ECC Care Systems – Pt ed

• Purpose of each step

• Why is it important?

• Neutralization of H2O2

MPS

• Preservatives

• Unique products

MPS - Preservatives

• Thimerosal (0.002%)

– Mercurial antibacterial

– Effective against gram + bacteria

– CYTOTOXIC to corneal epithelium

• May lead to Type IV hypersensitivity

– No longer used with SCLs, but may be in ocular

medications

MPS - Preservatives

• Benzalkonium Chloride (BAK)

– Cytotoxic to corneal epithelium

– May be in ocular medications

• Sorbic Acid = Potassium Sorbate

– Turns methafilcon lenses yellow (CooperVision Hydrasoft)

• Dymed & Polyquad

– Newer

– Larger molecule size to decrease toxicity

MPS – Unique Products

• New(est) kids on the block

• Abbott RevitaLens

• Alcon OPTI-FREE PureMoist

• Bausch + Lomb Biotrue

RevitaLens OcuTec MPDS

• Surfactant for lubrication

• EDTA (chelant)

– Decreases deposit formation

– Adds antimicrobial properties

OPTI-FREE PureMoist MPDS

• EDTA

• Wetting agent – EOBO (HydraGlyde)

– Reduces hydrophobicity of SiHy lenses

– Reduces LIPID deposits

Biotrue MPS

• Matches pH of tears

• Natural lubricant (similar to tears)

• Keeps beneficial tear proteins alive

Other products

• Rewetting drops

• Enzymatic cleaners

• Protein cleaners

Enzyme (Protein) Cleaners

NO YES

Daily 2 wk 1 mo >1 mo

Disposable Repl Repl Repl

Heavy coater

GPC

FDA – Current Review Process

• Reviews Safety and Efficacy

• Stand alone test

• Regimen test

FDA – Current Review Process

• Challenge Microorganisms

– Staphylococcus aureus & epidermidis (gram +

cocci)

– Serratia marcescens (gram – rod)

– Pseudomonas aeruginosa (gram – rod)

– Candida albicans (yeast)

– Fusarium solani (fungus)

FDA – What’s to come

• Acanthamoeba trophozoites & cysts

• New lens group

• New tests – “real world” scenarios

• Aug 2010 – reaffirmed rub & rinse regimen

A Few Bad Years!

• Fall 2005 – CIBA VISION discontinues all lens

care products

• Summer 2006 – B&L recalls ReNu MoistureLoc

• Fall 2006 – AMO recalls Complete Moisture

Plus

• Winter 2006 – B&L recall of ReNu MultiPlus

Fusarium Keratitis

• Fungal

• Can’t penetrate intact cornea

• Symptoms

– Redness

– Blurred vision

– Tearing

– Excessive discharge

– Sensitivity to light

Fusarium Keratitis

• May be misdiagnosed as bacterial microbial

keratitis

• Filamentous, irregular borders; elevated, dirty

grey

How Did It Happen?

• Newer, larger molecules coated the lenses

• Some molecules released from SiHy lenses

• Fungal keratitis – less than 1 in 1,000,000 per

year

• Microbial keratitis – 4-21 per 10,000 in SCL

wearers (higher in overnight lens use)

• Biofilm

Biofilm

• “a microbial community”

• Can aid in bacterial adhesion & colonization;

secretes substances that act as scaffold

• May contain multiple species of organisms;

can render resistance to biocidal properties of

lens care products

Acanthamoeba Keratitis

• Tap water - water treatment facilities

– EPA reduction of chlorine

– Distance from treatment facility

• Swimming, Hot tub

• Trophozoite vs cysts

• 1 in 30,000 hydrogel wearers

Lens Cases

• Cleaning?

• Additional antimicrobials

• Replacement?

• Reminder systems

Lens Cases - Cleaning

• Tap water? Saline? MPS? H2O2?

• Rub? Soap? Dishwasher?

• Tissue wipe?

• Air dry? Positioning?

• Where?

Lens Cases - Antimicrobials

– Impregnated with silver ions

• CIBA VISION PRO-GUARD case

– Significant reduction of challenge microorganisms

– Silver gradually released as case exposed to

moisture

• Amcon Laboratories I-clean case

• Brien Holden Vision Institute

– Antimicrobial material to coat cases – in progress

Lens Cases - Replacement

• Regularly. Monthly? Every 3 months? 6

months?

Lens Cases - Reminders

• LensAlert (Watch Dog Group LC)

– # days replace lenses

– # days replace case

• With every bottle?

Compliance

• “the extent to which a patient’s behavior

coincides with the clinical prescription” –

Sackett & Hayes 1976

• Reported range of noncompliance with

medical instructions of 8 to 92%

Handwashing

• Correct process?

– Soap & water

– Antimicrobial hand sanitizers – contain alcohol

• Harris Interactive Poll (2005)

– 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

• The Centers for Disease Control and

Prevention – Clean Hands Campaign

• Wash hands with soap & water for 20 secs =

time to sing “Happy Birthday” twice

• Warm water – better solvent than cold

Hand Drying

• Paper towel –slight decrease in bacterial load

– Lint free – good for CL care

• Hot air drying – increases bacterial load

Compliance – CL Patients

• PubMed search “compliance” + “contact

lenses”

– 163 refereed papers

– Numerous non-peer reviewed

– First relevant reference – JF Morgan, 1979

– First relevant study – Collins & Carney, 1986

Compliance – CL Patients

• 26% of soft contact lens patients were fully

compliant with lens care and maintenance

(Collins & Carney, 1986)

• Virtually all non-compliant with at least 1

required procedure (Turner et al, 1993)

• 24% never cleaned lenses before disinfection,

5% used saline to “disinfect” (Ky et al, 1998)

Instructions

• 79% admitted non-compliance in some area of

CL care (De Oliveira et al, 2003)

• 0.3% compliant with 14 steps required

(Morgan, 2007)

• Full compliance very rare (Morgan et al, 2011)

• Improves by explaining benefits of compliant

procedures (McMonnies, 2011)

AOA/AAO CL Sections Pt Ed

• Wash hands prior to lens handling

• Rub lenses

• Don’t top off solutions

• Clean & regularly replace cases

• D/C lens wear & immediately contact ECP if

symptoms of pain, blurred vision, redness,

increased tearing/photophobia

Building Compliance

• “Prescribe”, not recommend

– Write on an Rx pad

– Provide detailed written handout WITH soln name

• 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.

Oh Great!!

• “Patients are often lying when they say they

have regularly taken the prescribed medicine”

– Hippocrates, 400 BC

Problems

• Generics

• Saline

• Rub vs. No-Rub

• Staining

• Product confusion

Care System Identification

• 48% brand name MPS

• 9% H2O2

• 3.5% generic

• 40% unsure

• Product pictures help

Other Issues

• Daily disposable wearers

• Part-time wearers

• Silicone Hydrogel

• Piggyback/hybrid lenses

• Swimming