Contact Lens

Care & Maintenance

Lecture 5L1

Version:
2012.May.10
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 Published in Australia by
The International Association of Contact Lens Educators

Revised Edition 2011

The International Association of Contact Lens Educators 2000-2011

All rights reserved. No part of this publication may be reproduced, stored in a
retrieval system, or transmitted, in any form or by any means, without the prior
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 CONTRIBUTORS

Introduction to Contact Lens Care:

Lakshman Subbaraman, PhD, BSOptom, MSc, FAAO

Lewis Williams, AQIT (Optom), MOptom, PhD

For a complete list of acknowledgements please see

our website: www.iacle.org
WHAT IS CONTACT LENS CARE?
GP
GP CONTACT
CONTACT LENSES
LENSES

5L1-6
WHAT IS CONTACT LENS CARE?
SOFT
SOFT CONTACT
CONTACT LENSES
LENSES

5L1-7
 WHAT IS CONTACT LENS CARE?
SILICONE
SILICONE HYDROGEL
HYDROGEL CONTACT
CONTACT LENSES
LENSES

5L1-8
WHAT IS CONTACT LENS CARE?
GP
GP LENS
LENS CASES
CASES

5L1-9
WHAT IS CONTACT LENS CARE?
LENS
LENS CASES:
CASES: SCL
SCL

5L1-10
 THE IDEAL CONTACT LENS
CARE SYSTEM: AA BROAD
BROAD VIEW
VIEW

• Effective against all likely ocular pathogens

– contaminating lens care products, CLs & lens
cases
• Non-toxic to ocular tissues
• Compatible with all CLs
• Simple to use (makes non-compliance difficult)
• Disinfects rapidly
• Hydrates/conditions CLs,  wettability & comfort
• Prevents CL deposits (after Jones & Senchyna, 2007)

5L1-11
 THE IDEAL CONTACT LENS
CARE SYSTEM: AA NARROWER
NARROWER VIEW
VIEW

• Kills ALL viable organisms in:

– lens case
– solutions
– & on CLs
• Removes ALL:
– dead organisms
– skin lipids (from eyelids)
– tear, finger & air-borne contaminants
– cosmetic residues
– LCP residues & by-products
– any other contaminants
• Hydrates & conditions lenses  ready-to-use
• Non-toxic
• Suitable for all CLs
• Quick acting (to allow disinfection between brief uses)
5L1-12
 CONTACT LENS CARE
FDA HYDROGEL LENS GROUPS
FDA material groups proposed July, 1985 [Stone (1988)]
System uses the filcon stem for hydrogels (however HEMA remains polymacon)
System extended to GP materials mid-2000s, employs the focon stem
An ISO categorization also exists (uses FDA stems): PMMA is focon 1a & HEMA is filcon 1a
Currently, the re-categorization of SiHy lenses is being considered

• Group 1 Low water content, non-ionic

• Group 2 High water content, non-ionic

filcon stem

• Group 3 Low water content, ionic

• Group 4 High water content, ionic

5L1-13
 CONTACT LENS CARE
FDA HYDROPHOBIC LENS GROUPS
(Stone [2007])

• Group 1 No silicon or fluorine content

• Group 2 Contains silicon but no fluorine

focon stem

• Group 3 Contains silicon & fluorine

• Group 4 Contains fluorine but no silicon

5L1-14
 THE IDEAL CONTACT LENS
CARE SYSTEM

• Restores lenses to factory-original condition

• Maintains lenses in this condition for as long as

required (or at least until their next use)

Unfortunately, these ideals are seldom

realized in the real world

Once on the eye, the factory-original condition of a new CL cannot be restored

5L1-15
 FACTORS
FACTORS ALTERING
ALTERING PERCEPTIONS
PERCEPTIONS OF
OF
LENS
LENS CARE
CARE

• >20 years of disposable CLs

• >15 years of daily disposable CLs (requiring no lens care)
• Claims of lower complication rates from disposable & regular-
replacement CLs
• The advent of ‘convenient’ LCPs
– multi-purpose solutions (MPSs)
– the  availability of single-purpose products
– the  in the number & variety of LCPs marketed
– the  in the number of manufacturers of LCPs
• The promotion of NO RUB & NO RUB products
• Relatively few problems reported

5L1-16
 DEFINITION OF CL DEPOSITS

Any surface coating or contaminant, or any

formation within the CL matrix, that is not
flushed or wiped from the lens by the combined
actions of the tears & blinking

Realistic addendum: …and that is not removed by

routine CL care procedures following CL wear

5L1-17
 WHAT HAPPENS WHEN LENS
CARE IS IGNORED
Deposited CLs

Lipid Lipid Lipid-Calcium

Protein Poor wetting

5L1-18
 Normal

CLPC: White light CLPC: Blue light + fluorescein + yellow

barrier filter

5L1-19
 CLARE: Contact Lens-induced Acute Red Eye

The yellow dots in the diagram above represent

diffuse infiltration (larger dots) and focal
infiltrates (smaller dots). There is little or no
corneal staining. The most obvious sign is
conjunctival & limbal injection, hence the term
‘red eye’ (see image  )

5L1-20
Microbial adhesion to CLs

S. aureus P. aeruginosa

Acanthamoeba sp. Hyphae of fungus

5L1-21
WHAT HAPPENS WHEN LENS CARE IS
IGNORED
MK: Microbial keratitis

Corneal infiltrate

Acanthamoeba keratitis: Late stage

The ‘ring’ form is pathognomonic of Acanthamoeba keratitis

5L1-22
 Reduced vision with soiled CLs

D F Reduced vision quality

(VA with low contrast chart

E F D E
often more ‘revealing’)

P R U Z U R
Z H U V P V N F
E N D F U Z E D N E Z F U
P R U D E N V H Z F V Z F H E N U D R P

Assess with
high & low contrast
Snellen charts

5L1-23
 CONTACT LENS CARE
THE CURRENT SITUATION

• The Convenience Factor

– 1-step peroxide systems

– MPSs (>1 function in a single product)

– DD CLs (usually, no lens care)

• But at what cost?

5L1-24
 CONTACT LENS CARE
THE COST

• Fusarium spp. infections

• Acanthamoeba spp. infections
• Lost vision, penetrating keratoplasties
• LCP recalls
• FDA & other regulators forced to investigate care system
performance, esp. against fungi & Acanthamoeba spp.

5L1-25
 WORLD CONTACT LENS MARKET
2010
International CL Markets 2010
Morgan et al., 2011
Country Rigid OK DDs Other DW Soft SiHy DW Soft EW

CL Spectrum 2011 Jan issue Australia

   
0%
 
0%
 
26%
 
16%
 
48%
 
10%
Bulgaria 4% 0% 5% 8% 68% 15%
Rigid = PMMA CLs + GP CLs
Canada 1% 0% 17% 13% 66% 3%
China 2% 0% 27% 55% 1% 15% OK = Orthokeratology CLs
Czech Republic 2% 0% 17% 21% 51% 10% =DD SCLs + DD SiHy
Morgan PB et al., 2011

Denmark 1% 0% 55% 14% 23% 6% DDs SCLs

Spain 9% 0% 16% 43% 29% 3% Other DW
= Non-SiHy DW SCLs
France 16% 0% 15% 9% 58% 2% Soft
Hong Kong 4% 0% 63% 13% 19% 1% SiHy DW =Non-DD SiHy DW SCLs
Croatia 20% 0% 6% 12% 62% 0%
Soft EW = EW SCLs + EW SiHy CLs
Israel 21% 1% 24% 23% 29% 2%
Iceland 0% 0% 45% 25% 25% 5%
Japan 20% 0% 31% 26% 23% 0%
South Korea 9% 0% 55% 15% 14% 7%
Lithuania 0% 0% 18% 22% 36% 25%
Netherlands 24% 6% 8% 17% 40% 5%
Norway 1% 0% 35% 9% 24% 31%
Nepal 13% 0% 0% 79% 4% 4%
New Zealand 16% 4% 13% 20% 41% 5%
Portugal 18% 8% 9% 24% 34% 7%
Romania 0% 0% 21% 3% 65% 11%
Russia 3% 0% 23% 33% 32% 9%
Sweden 2% 1% 21% 17% 45% 13%
Slovenia 11% 0% 7% 51% 31% 0%
Taiwan 0% 0% 70% 29% 0% 0%
United Kingdom 4% 0% 37% 12% 40% 8%
United States 8% 1% 15% 15% 54% 8%
             
Overall 9% 1% 29% 22% 32% 7%

5L1-26
 WORLD CONTACT LENS MARKET
THE FUTURE

  dominance of disposable CLs

•  Rx range already available

•  range of BOZRs possible

•  range of TDs less likely

• Evolution of CL materials

5L1-27
 WORLD CONTACT LENS MARKET
THE FUTURE

What follows SiHy CLs?

• DD SiHy to  their market share

• DDs in conventional hydrogels to 

• parameter range likely to remain limited

• trade-off between inventory size required &

parameter range stocked

5L1-28
 WORLD CONTACT LENS MARKET
THE FUTURE

• Hybrid CLs to have an impact as technology evolves &

parameter range & number of indications 
– care required when selecting lens care

• Conventional lenses to remain available

– special lenses
– custom Rxs
– extreme Rxs
– trial lenses for all of these

5L1-29
 WORLD CONTACT LENS MARKET
THE FUTURE

• MPSs domination to continue

– single-purpose products - small market share only

• Market & products for protein removal will  further as

disposable lenses achieve even greater market
penetration

5L1-30
 WORLD CONTACT LENS MARKET
THE FUTURE

• Peroxide seen as problem solver

• Rivalry between polihexanide (PHX) & polyquaternium
(PQ-1) disinfectants to  as products containing BOTH are
released
– so-called dual-action products
• Opportunities for novel disinfectants exist
– but small number of manufacturers an issue
• Material compatibility to remain an issue

5L1-31
 CONTACT LENS CARE
DEPOSITS

• CLs still deposit-prone

• Deposit type & deposition rate depend on CL material
& patient characteristics
• Simply, disposability only cuts short the deposition
process
  clinical significance, usually to subclinical
levels
– obviates the need for ‘deep’ cleaning
  or avoids the need for protein removal
• DD may be the ultimate answer

5L1-32
 CONTACT LENS CARE
IN THE DISPOSABLE LENS ERA

SUMMARY
• The need for lens care remains unchanged
• Disposable CLs do not need protein removal
– if protein deposits prove to be a problem,
review frequency of disposal
• DDs = the answer for many but not all wearers
• LCP performance likely to 
• The perceptions surrounding the  importance of lens
care are FALSE

5L1-33
CONTACT LENS CARE
THE MAIN STEPS

5L1-34
 CONTACT LENS CARE
HAND CLEANING

• Cleaning hands before CL handling is THE starting point

for sound & efficacious lens care
– use potable water & select ‘plain’ soap (fragrance-free, little/no
colouring agents, etc.)
– include palms, between fingers, under fingernails
– lather & rub - minimum of 15 seconds
– rinse soap off thoroughly (10-15 sec)
– dry hands with low-lint or lint-free towel
— paper towel is unsuitable
— use towel to turn tap off
– once clean, take care with what the hands touch

5L1-35
 CONTACT LENS CARE
LENS CLEANING

• Cleaning CLs is part of the disinfection

process

– cleaning significant  in microbial load

(Houlsby et al., 1984, Shih et al. 1985, 1991)

– rubbing & rinsing  corneal staining (at least

with the combination of balafilcon-A SiHy CLs & a PHX-

based MPS) (Peterson et al., 2010)

5L1-36
 CONTACT LENS CLEANING
RUB or NO RUB?

NO RUB
Why?
• Rinsing alone does not detach adherent/penetrating fungi
• Micro-organisms are not the only ‘concern’
– other lens contaminants also require removal
 finger-borne contaminants (lens handling)
– inevitable surface deposition needs to be contained
– a clean lens is usually more comfortable
• Lens wettability is enhanced
(see review by Butcko et al., 2007)

5L1-37
 CONTACT LENS CARE
LENS CLEANING continued…
continued…

• Clean back & front surfaces

– 10 – 15 seconds per side
– roll the forefinger to ensure
contact between outer lens
surfaces & palm
• Keep palm taut (wrinkle-free)
• Beware long fingernails,
especially with SCLs

5L1-38
 CONTACT LENS CARE
LENS CLEANING continued…
continued…

• To  control of CL, use to & fro & L to R

movements rather than ‘orbiting’
• Use relatively dry forefinger to propel CL
• 2-3 drops of cleaner or MPS
• Clean front first before getting ‘slippery’
cleaner on back
• Evert lens & repeat for back
– arguably, back requires less time
(e.g. 10 seconds)

5L1-39
 CONTACT LENS CARE
LENS RINSING

• Rinse thoroughly using jet of sterile

saline or MPS
• Rub lens with forefinger to assist the
removal of cleaner & loosened lens
contaminants
• Both lens surfaces should wet completely
• No contaminants should be visible

5L1-40
 CONTACT LENS CARE
LENS RINSING continued…
continued…

• Lens shape should be normal & undistorted

– suggests normal hydration levels

• Shake-off excess rinsing solution before

installing CLs in lens case
• CLs should be rinsed once again after
completion of the disinfection step, just prior
to reinsertion

5L1-41
 CONTACT LENS CARE
LENS RINSING

Regardless of its quality,

tap water has no rôle
in the care of contact lenses
(it is NOT a sterile product)

Equally, bulk, unpreserved normal saline is unsuited to lens care

once it has been opened for more than a few hours
(wide-mouth bottles are best avoided altogether)
5L1-42
 CONTACT LENS CARE
RINSING SOLUTIONS
• Saline:
– bulk (125 mL – 1 L), unpreserved (a.k.a. pharmacy saline, irrigation
saline, intravenous saline [injectable quality])
– bottles may have a jet dispenser or a wide mouth, intravenous saline
is usually supplied in an IV plastic bag
– bulk preserved (a.k.a. sterile saline)
– unit-dose (single-dose)
• MPS

5L1-43
 CONTACT LENS CARE
SALINE SOLUTIONS
(Carney et al., 1990)

Property changes in saline solutions can

occur with
inappropriate storage conditions

5L1-44
 CONTACT LENS CARE
ANTIMICROBIAL ACTIVITY
After Wikipedia @ 2009-Apr-23
Levels of efficacy:

• Sterilization: Any process that kills or eliminates

transmissible agents
• Disinfection: The killing and/or the removal of some or all
resident pathogenic organisms
• Preservation: The killing, and/or the inhibition of growth, of
selected micro-organisms

5L1-45
 ANTIMICROBIAL AGENTS
MODES OF ACTION

• Damage cell membrane

• Damage cyst wall (encysted species)
• Damage outer cytoplasmic membrane (bacteria) or
plasma membrane (fungi)
• Interference with synthesis of cell wall peptidoglycans
• Alteration/binding/damage/interference with DNA
• Inhibition of synthesis of folic acid, nucleotides, or protein
• Dehydration of cell
• Induction of autolysis
• Potentiation of actions of co-located antimicrobials

5L1-46
 CONTACT LENS CARE
PRESERVATIVE CHARACTERISTICS

• Inhibit all microbial growth

• Maintain the number of micro-organisms below a certain
(safe) level
• Act as a LCP ‘defence system’
• Must be:
– compatible with ingredients, CLs, & container
– non-toxic & non-irritating
– stable over time
More information on
– effective against a broad spectrum PRESERVATION
of organisms

5L1-47
 CONTACT LENS CARE
DISINFECTION: TARGETS

Ocular pathogens:

• Bacteria
S. aureus P. aeruginosa
• Viruses

• Protozoans

• Fungi
Acanthamoeba sp. Hyphae of fungus
• Spore forms of any of the above

5L1-48
 CONTACT LENS CARE
DISINFECTION: NEED

Contact lenses may compromise the eye’s natural

defence by:
• Inhibiting tear film’s washing action
• Introducing more micro-organisms via:
– fingers
– solutions
– environment
• Compromising the epithelial barrier function

5L1-49
 CONTACT LENS CARE
CHARACTERISTICS
CHARACTERISTICS OF
OF A
A DISINFECTANT
DISINFECTANT

• Kills or deactivates potentially pathogenic organisms

remaining on CLs
• Rehydrates CLs (GP, SCL, & SiHy) & maintain CL
hydration subsequently
• Maintain microbial safety during storage
• Must be:
– compatible with LCP ingredients, CLs, & container
– non-toxic & non-irritating to the eye
– stable over time

5L1-50
 CONTACT LENS CARE
DISINFECTION: D-VALUE

106

CFUs Surviving/mL (Log Scale) 105

Th An actual curve
eo
re
104 tic
al
Su
rv
iv or
103
CFUs Cu
Colony-Forming rv
e
Units 10 2

Another actual curve

101

0
0 10 20 30 40 50 60 70 80 90 100
TIME (Min)

5L1-51
 CONTACT LENS CARE
DISINFECTION: D-VALUE
106

(about 16 min in this case)

CFUs Surviving/mL [Log Scale]

105 [a poor disinfectant or

a resistant organism?]

104 1 Log = 90% 

2 Log = 99% 
3 Log = 99.9% 
103 (a 90% reduction in 4 Log = 99.99% 
Su the number of CFUs
rv surviving) 5 Log = 99.999% 
ivo If the inoculum is
102 rC
ur large, these
ve figures become
less impressive
101

0
0 10 20 30 40 50 60 70 80 90 100
TIME (Min) [Linear Scale]

5L1-52
 CONTACT LENS CARE
FACTORS AFFECTING DISINFECTION

• Microbial population size

• Microbial growth conditions
• Concentration of disinfectant
• Environmental factors
• Microbial resistance (natural & acquired)

5L1-53
 CONTACT LENS CARE
DISINFECTION: STANDARDS

ISO 14729: Test Panel (TP) of Organisms

• Fungi:
– Candida albicans ATCC 10231
– Fusarium solani ATCC 36031

• Bacteria:
– Pseudomonas aeruginosa ATCC 9027
– Serratia marcescens ATCC 13880
– Staphylococcus aureus ATCC 6538

Note: Currently (2011), Acanthamoeba spp. are not featured in the Test Panel. Therefore,
there is no mandated requirement that a solution or product needs to meet in regard to
Acanthamoeba spp. This may change following discussions between 2008 & 2010

5L1-54
 CONTACT LENS CARE
DISINFECTION: CRITERIA

ISO 14729: Performance Requirement (inoculum 106 CFU/mL)

• Stand Alone Test (no CLs involved, fresh solutions used)
– Primary Criteria (LCP used in isolation):
 mean 3 log  of TP bacteria in MRDT*
 mean 1 log  of TP fungi (moulds & yeasts) in MRDT
– Secondary Criteria (LCP as part of a system, no CLs):
 mean 5 log  over ALL bacteria (in MRDT), and…
 mean 1 log  of EACH bacterium
 NO growth (stasis) of the TP fungi within the MRDT
(error allowed  0.5 log)

5L1-55
 CONTACT LENS CARE
DISINFECTION: CRITERIA continued
continued…

ISO 14729: Performance Requirement

• Regimen Test (full care regimen & CLs used)

– fewer than 10 CFU of any TP organism to remain on

EACH test CL after MRDT

 if original inoculum is large, this is a stringent

requirement as it could translate to a >6 log-unit 

5L1-56
 CONTACT LENS CARE
DISINFECTION METHODS

• Heat (thermal unit, microwave oven, other)

– now historic interest only

• Chemical

- oxidative (e.g. hydrogen peroxide)

- cold chemical

- various disinfectants

5L1-57
 CONTACT LENS CARE
A BALANCE: EFFICACY vs TOXICITY

• Strong preservatives/disinfectants used only in products that NEVER

come in contact with the eye, e.g. CL cleaners

• MPSs must balance efficacy & toxicity

– CLs carry MPSs into eye

  disinfection regulations  difficulty balancing these competing factors

• So-called ‘disappearing’ disinfectants/preservatives used in some in-eye

preparations & a LCP

– they are not strong disinfectants

5L1-58
 CONTACT LENS CARE
ADVERSE REACTION TO A LCP

SYMPTOMS SIGNS

• Sudden  in satisfaction • Conjunctival redness

  wearing time (2-4 hours) (general/local)
• Burning, grittiness, dryness, • Epithelial damage (diffuse
discomfort corneal staining)
• Corneal inflammation
(if severe)

5L1-59
 CONTACT LENS CARE
STORAGE
STORAGE &
& CONDITIONING
CONDITIONING SOLUTIONS
SOLUTIONS

• S&C solutions for GP CLs only

• After cleaning & rinsing CLs  S&C solution

• Lens hydration restored & maintained

• After cleaning & rinsing low CFU count is  further by the disinfectant
in S&C

• Lens wettability  by wetting agents in S&C

• While S&C solutions are compatible with the anterior eye, a

conservative approach is to rinse the CLs in sterile saline immediately
before use

5L1-60
 CONTACT LENS CARE
WETTING SOLUTIONS
• GP CLs only
• Solution is applied to GP CLs immediately before insertion
• Solution contains:
– surfactants
  lens surface tension &  lens wettability
– viscosity-increasing agent(s)
 cushions lens on insertion &  lens lubricity
  comfort on insertion
• Preserved unless unit-dose (single-dose)
• Rôle largely overtaken by S&C solutions or MPSs
• Few products available currently

5L1-61
 CONTACT LENS CARE
PROTEIN REMOVAL

• Targets tear film proteins, especially lysozyme

• Most are proteolytic enzymes
– some are inorganic
• Some used separately, others suitable for use in MPSs or
1-step peroxide systems
• Some are peroxide-specific (compatible with H2O2 & its
low pH)
• Unnecessary for lenses discarded frequently

5L1-62
 CONTACT LENS CARE
PROTEIN REMOVAL: THE #1 TARGET

To remove a protein, it
must be hydrolyzed
For lysozyme, the
four S–S bonds must
be cleaved (broken) to
allow an ‘unraveling’ of
the protein chain

5L1-63
 CONTACT LENS CARE
PROTEIN REMOVAL

• Used periodically (typically weekly)

– after clean & rinse, or…
– concurrently in 1-step care system
• Heavy depositors require  treatment frequency,
especially group IV hydrogels
– consider replacing CLs more often
• CLs must be re-cleaned & re-rinsed
after protein cleaning (ocular exposure to enzyme
undesirable)

5L1-64
 CONTACT LENS CARE
PUT SIMPLY

• Attain a ‘ready-to-wear’ state

• Maintain that ‘ready-to-wear’ state

5L1-65
 CONTACT LENS CARE
RE-WETTING DROPS/LUBRICANTS

In-eye products:
•Soothe dry, irritated, tired, or sensitive eyes
•Preservative-free (unit-dose) or low-irritant preservative
•Alleviate discomfort  insufficiently lubricious tears
– or insufficient tear volume
•Alleviate dryness towards end of CL wear
•Rehydrate CLs in situ
•Flush/clean debris from lens surfaces & eye
 tear protein denaturation &  surface deposition
•Viscous fluid envelope cushions CLs in situ

5L1-66
 CONTACT LENS CARE
RE-WETTING DROPS/LUBRICANTS

Challenges: (after Tonge et al., 2001)

• Rapid fluid loss (patent tear drainage system)  short
anterior eye stay-time (short residency)
  solution viscosity 
  drainage
  absorption by conjunctival vasculature
– alternatively, incorporating a mucoadhesive polymer
may  stay-time

5L1-67
 CONTACT LENS CARE
RE-WETTING DROPS/LUBRICANTS

• Narrow & stable range of tear pH

• Cornea has low permeability to most solution
constituents
• If preserved,
– tear stability, tear BUT & corneal and conjunctival
cell integrity may be affected adversely
– dry eye symptoms can be induced

5L1-68
 CONTACT LENS CARE
LUBRICANTS: DO THEY WORK?
“Neither lubricant tested was found to be significantly
superior to saline” (Efron et al., 1990)

• Has the situation improved?

– formulations are now more complex & sophisticated with claims of
 performance
– SiHy CL wearers may benefit (see Notes)
• Regular use can exacerbate rather than alleviate the original problem
• Avoid using in-eye products just before CL removal (makes CLs
slippery, & if hypertonic, tighter fitting)

5L1-69
 CONTACT LENS CARE
RE-WETTING DROPS/LUBRICANTS

Does the need for these products actually overlap:

• An underlying ocular condition?
or
• Ocular surface disease, e.g. dry eye?

5L1-70
 CONTACT LENS CARE
CONTACT LENS CARE EPHEMERA
Many gadgets, ‘innovations’, novel ideas,
resurrection of old ideas, etc. appear regularly,
few survive. The reasons for failure include:

•Does not work or not sufficiently efficacious

•Product is actually flawed or even dangerous
•Too expensive
•Failed to get regulatory approval
•Research studies reach adverse conclusions
•Competitor product wins marketing war
•Supplying company fails
Planetary-gear devices (swishers)
•Key component(s) no longer available
•Product’s function becomes redundant

5L1-71
 CONTACT LENS CARE
COMPLIANCE

McMonnies (1988): With new wearers, compliance

problems may start at the delivery visit

Radford et al. (1993): After instruction & suitable re-

instruction, an 85% compliance rate is achievable

Claydon et al. (1996): In a reasonably compliant

group of wearers, additional education had no
significant effect on compliance levels

Overall compliance with lens care

instructions is 40% to 74%

5L1-72
 CONTACT LENS CARE
NON-COMPLIANCE
Non-Compliance:
• Failure to return for after-care
• Not adhering to prescribed CL wearing schedule
  life of CLs >recommended
• Failure to understand the requirements for, or significance of,
the various lens care steps
• Skipping the cleaning and/or disinfection steps
• Using  quantities of LCPs than recommended
• Poor general hygiene
• Failure to clean or replace lens case (Woods et al., 2010)
• Not following manufacturers’ instructions (lenses, LCPs)

5L1-73
 CONTACT LENS CARE
NON-COMPLIANCE

• Non-compliance is probably the greatest source of CL-

related complications and is a barrier to long-term
successful CL wear
• Lowest reported rate is 26%

• Highest rates reported:

– 60% - 85%

• Importantly, non-compliance   complication rates

5L1-74
 CONTACT LENS CARE
NON-COMPLIANCE

• 70% non-compliance rate was reported among 215

microbial keratitis (MK) cases (Abry et al., 2010)
– 96% were wearing disposable CLs
– 30% were SiHy CLs
– only 45% of MK patients rubbed & rinsed CLs
• Wearer perceptions  indicator of behaviour:
– 86% rated themselves compliant, only 76% were good or
average (24% non-compliant)
– 80% were risk aware but this had no effect on negative
behaviour (Bui et al., 2010)

5L1-75
 CONTACT LENS CARE
FACTORS AFFECTING COMPLIANCE

Positively:
• Patient education
• Practitioner attitudes & communication skills
• Use & supply of clear, illustrated instructions
• Simplicity of the lens care system
• Review procedures at every opportunity

5L1-76
 CONTACT LENS CARE
FACTORS AFFECTING COMPLIANCE

Negatively:
• Poor or no education from the practitioner
– failure of patient/practitioner ‘partnership’
• Being <30 & using CLs for cosmesis or convenience
• Being 10-30 or >50 or with more than 2 years of lens-
wearing experience
• Differing advice from different practices
• Being a risk taker

5L1-77
 CONTACT LENS CARE
FACTORS AFFECTING COMPLIANCE
(after Shannon,1987)

Negatively:
• Complexity of the procedures recommended

• Length of time required to perform prescribed tasks

• Cost of the regimen

• Poor understanding of instructions

• Poor, or no, patient-practitioner relationship

5L1-78
 CONTACT LENS CARE
FACTORS AFFECTING COMPLIANCE

Negatively:
• Wearer ‘discovering’ a more ‘convenient’ way or an ‘easier’ way
• Laziness
• Erroneous information provided by well-intentioned, ‘helpful’
friends
• Following instructions correctly for different, irrelevant, LCP
and/or CLs
• The awe-struck wearer who is afraid to question the practitioner
or confirm what they think they heard
• Inappropriate practitioner attitudes that act as barriers to
communication

5L1-79
 CONTACT LENS CARE
FACTORS
FACTORS NOT
NOT AFFECTING
AFFECTING COMPLIANCE
COMPLIANCE

• Additional education (esp. if level of compliance is relatively high

already) (Claydon et al., 1996, 1997)

• Shannon (1987):
– age (other studies suggest age is a factor)
– wearer’s sex
– occupation
– perception of threat or consequence of disease
– race
– highest education level achieved
– socio-economic group

5L1-80
 CONTACT LENS CARE
OTHER COMPLIANCE ISSUES

• What to do if a red eye is noted?

• Swimming in CLs against advice
• CL storage if not used for extended periods (should they be
stored at all?)
• Mixing & matching LCPs - different systems, different
manufacturers
• Being swayed from prescribed products/procedures by third
parties (other professionals, e.g. pharmacists)

5L1-81
 CONTACT LENS CARE
OTHER COMPLIANCE ISSUES

• Defaulting to ‘No Rub’ when ‘Rub’ was prescribed

– ‘corner cutting’, laziness/haste, ignorance
(after Woods et al., 2010)

• Re-use and/or topping-up (topping-off) of remaining

spent solution is a flawed pursuit & a false economy
– the Fusarium spp. issue of 2006
– the Acanthamoeba spp. issue of 2007
— use of tap water was also implicated

5L1-82
 CONTACT LENS CARE
OTHER COMPLIANCE ISSUES continued…
continued…

Convenience of a system may determine:

• Patient compliance
• Frequency of lens wear (intermittent?)
• Patient satisfaction
• Continued use of recommended care system
components (a more convenient alternative?)

5L1-83
 CONTACT LENS CARE
FDA RECOMMENDATIONS 2010

• Follow recommended wearing schedule

• Do not substitute sterile saline for MPSs

• Rub & rinse CLs as directed by your eye care professional (ECP)

• Do not ‘top-up’ (top-off) solutions in your case. Always discard all of the
leftover solution after each use. Never reuse any lens solution

• Clean, rinse, & air-dry your lens case (upside-down) each time CLs
removed

• Do not expose your CLs to water: tap, bottled, distilled, lake, ocean, etc.

• Contact your ECP if symptoms of eye irritation or infection occur

5L1-84
 CONTACT LENS CARE
LENS STORAGE & LENS CASE CARE

Contact lenses should be stored in:

• A clean contact lens storage case
• Fresh disinfecting solution
Lens case care is an important but often ignored aspect of contact lens care
Lens cases are a potential source of lens recontamination
Microbial contaminants create biofilms in lens cases for self-protection

5L1-85
 CONTACT LENS CARE
LENS CASE BIOFILM SCHEMATIC
Generalized micro-organism
More mature form

x)
atri
x
ri m
at mer
m ly
Planktonic cells de
i r po
r
a a
c ch ellul
ly sa trac
x
po (e o
Ex

Sessile cells
Micro-colony Macro-colony Macro-colony Substrate (e.g. lens case)
Attachment Phase Growth Phase Maturation Release & Dissemination Phase
Reversible then
Colonization (If conditions are favourable)
irreversible
Seconds Seconds - Minutes Hours - Days Hours - Days Days - Months
5L1-86
 CONTACT LENS CARE
COMPLIANCE & LENS CASE CARE

• Lens case hygiene, care, & replacement have been identified as a

common compliance issue

• More frequent case contamination reported with 1-step peroxide systems

than with 2-step peroxide or MPSs

• Use of tap water at any stage of lens care NOT RECOMMENDED

• CL cases became contaminated after just 1 week & moderately to heavily

contaminated after 2 weeks

– 47% of cases were contaminated with Gram+ bacteria

– 21% with Gram– bacteria

5L1-87
 CONTACT LENS CARE
LENS CASE CARE
• Rinsing alone is incapable of removing adherent organisms
• Hot water & air-drying  bacterial contamination
• Recommendations:
– water temperatures >70°C, or…
– unneutralized peroxide for >20 min, or…
– bleach (sodium hypochlorite [NaOCl]) for >20 min
and…
– periodic scrubbing with dishwashing detergent, bleach, or
peroxide & water using a stiff brush to disrupt any biofilm
established inside the case & lid, & case/lid screw threads

5L1-88
 CONTACT LENS CARE
LENS CASE: RECOMMENDATIONS

• Monthly case replacement is ideal ‘compromise’

• Always avoid tap water
• Use MPS or unneutralized H2O2 as case disinfectant
• Daily:
– discard ALL remaining solution after lens insertion
– rinse in hot water
– air dry upside-down
• Weekly:
– scrub case using stiff brush & peroxide or bleach
– disinfect case with peroxide or bleach for >20 min
– rinse thoroughly with sterile saline just before re-use

5L1-89
 CONTACT LENS CARE
LENS CASE CARE: OTHER ISSUES

• The supply of new lens case with each bottle of solution has met with
limited success
– some CL wearers are ‘collectors’. Each new case becomes part of a
‘collection’ of unused cases thwarting the original intention
– ‘collecting’ is encouraged by cases that are well-designed, attractive, & well
finished
– conversely, cases made as low-cost, disposable items may be perceived
poorly. Functionally, they may also be inadequate, e.g. they might leak
• The cost of complex cases, e.g. vented peroxide cases, may make the
cost of frequent disposability prohibitive

5L1-90
 CONTACT LENS CARE
LENS
LENS CASE
CASE CARE:
CARE: OTHER
OTHER ISSUES
ISSUES

• In a ‘connected’ world, confusion can result from:

– different marketing policies applying in different countries to
identical products
– identical products marketed under different names and/or
packaging
– different products marketed under identical names in different
countries
• Nanotechnology is now being deployed in the CL world
– used in some lens cases, e.g. silver (Ag) is in the case
polymer & plays anti-microbial & anti-biofilm rôles

5L1-91
 CONTACT LENS CARE
WEAR MODALITY & LENS TYPE

Lens Replacement Scheduling:

• >12 months – has no place in CL practice
• Conventional wear (12 months) - discourage
• Frequent/programmed replacement (>1 month replacement)
• Disposable (1 week to 1 month)
• Daily Disposable
• Other (as prescribed or by non-compliance)

5L1-92
 CONTACT LENS CARE
WEAR MODALITY & LENS TYPE

Lens Wear Modalities:

• Daily wear (DW)
– DD (single-use)
– Disposable
– Programmed replacement
– Conventional
• Flexible wear (FW) - disposable
• Extended wear (EW) - disposable
• Continuous wear (CW) – single-use

5L1-93
 CONTACT LENS CARE
WEAR MODALITY & LENS CARE

Lens Wear Modalities: Lens Care:

• Daily wear (DW)
– DD (single-use) • None
– Disposable • Normal
– Programmed replacement • Normal
– Conventional • Full (+ protein removal)
• FW - disposable • Full
• EW - disposable • Full
• CW - single-use • None

5L1-94
 CONTACT LENS CARE
SELECTING A CARE REGIMEN

• Wearing schedule (5/7, 7/7, DW, FW, EW, CW)

• Lens material (FDA group, SiHy, GP, Hybrid)
• Lens replacement schedule (DD, 2 wk, 1 mth, 3 mth,
annual, other)

• Convenience (safety still a consideration)

• Ocular sensitivity (personal/family history, known issues)

5L1-95
 CONTACT LENS CARE
LEGAL ISSUES

Potentially, the use and/or recommendation of

unapproved lens care procedures and/or products,
or off-label recommendations for approved
products, has legal implications for the contact lens
practice & practitioner.
The implications may be serial

5L1-96
 CONTACT LENS CARE
SILICONE HYDROGELS 0
After a decade of development, silicone hydrogel CLs (a.k.a. siloxane
hydrogels, SiHy CLs) were launched in 1999

• Initially, the SiHy manufacturers simply recommended their own LCPs

• Anecdotal information suggested that more superficial corneal staining was being
observed with some combinations of SiHy CLs & MPSs
• The matter was brought to a head by a report by Epstein (2002) & the series of claims &
counter claims that ensued (2002-2004). Some of the ensuing responses had marketing
overtones
• Most patients & practitioners were unaware of the issue because the ‘staining’ peaked
after about 2 hours of lens wear & comfort remained unaffected,
• Investigations revealed that some LCP formulations did result in more superficial staining
with some SiHy lenses. Initial assumptions that the disinfectant was the cause were
shown to be false because other products with the same disinfectant remained problem-
free. This suggested specific formulations (or combinations of excipients) were the issue

5L1-97
 CONTACT LENS CARE
SILICONE HYDROGELS 1

• The reports exposed an unmet need for SiHy LCPs if the ‘problems’
reported were to be addressed adequately
• Subsequently, LCPs targeting SiHy CLs were released
• Throughout this saga, hydrogen peroxide’s status as the yardstick
against which other LCPs should be measured, was confirmed, even
when used with SiHy CLs
• For practitioners, it was also a salutatory lesson on how easy it is to
jump to logical but erroneous conclusions when inadequate ‘research’
(or no research) in undertaken
• Industry’s seizure of the obvious but ultimately hollow marketing
opportunities, also provided a valuable lesson

5L1-98
 CONTACT LENS CARE
TO RUB OR NOT TO RUB
• The benefits of CL cleaning by rubbing have been detailed already & have been
long understood
• The Fusarium spp. & Acanthamoeba spp. events of 2005-2007 revealed several
potential problems compounded by the usual compliance issues
• The down-side of the wide acceptance & promotion of a ‘No Rub’ approach
became apparent
• All stakeholders, many of whom never supported ‘No Rub’, now agree that
rubbing is required
• Erasing the entrenched ‘No Rub’ culture will take time & effort by all, especially
practitioners
– omitting rubbing is the easiest form of ‘non-compliance’
• Regulation & approval of Patient Instruction inserts is an obvious next step
– differing regulations around the world are unhelpful

5L1-99
 CONTACT LENS CARE
TINTED LENSES

• As an added CL ‘feature’, modern CL tinting technologies were developed with a

full knowledge of LCPs
• Hydrogen peroxide systems pose no special risk to tints
• Usually, so-called ‘crazy’ or ‘fun’ CLs are made of conventional materials using
accepted tinting & artwork technologies. Such CLs require conventional lens
care (a fact lost on far too many ‘buyers’)
– commonly, these CLs are sourced from unregulated suppliers with no CL
professional involvement
– this means little or no lens care & unsafe wearing habits. Wearers
swapping CLs is reportedly common. Overall, this situation is a danger to
the wearer’s health & the reputation of the CL industry
– many jurisdictions have resorted to specific legislation
targeting the illegitimate & unsafe supply of non-Rx CLs

5L1-100
 CONTACT LENS CARE
LONG-TERM STORAGE OF CLs

• Home or CL practice, long-term CL storage is potentially risky

• Unneutralized H2O2 ideal medium for CL storage. However, its
long-term stability, while high, requires a vented container.
Decomposition  gaseous oxygen   pressure in sealed
container - case rupture possible
• Because safe, long-term storage is difficult technically, it should be
actively discouraged. In era of disposable/frequent replacement,
this should be easier to achieve
– generally, those with unusual Rxs not available as disposable
CLs, need to wear their CLs regularly & are therefore  likely to
need to store CLs
5L1-101
 CONTACT LENS CARE
LONG-TERM STORAGE OF CLs
• For CLs that cannot be discarded but can be disinfected thermally (@ 70° - 80°C) thermal
disinfection is the safest
– before disinfection, CLs should be sealed in a glass vial with a silicone bung (plug) &
a crimped, tear-off, metal seal
– once disinfected, the vial should remain unopened until needed
• If unsuited to heating, a regimen of a MPS in a new case (biofilm-free) with scheduled,
regular solution changes is required. This is difficult to orchestrate:
– the solution must be ‘in date’ and within its ‘discard after’ period
– some form of assurance/confirmation (written) that the necessary steps have been
performed, is required
— solution changes need to be scheduled for every 1-2 weeks (for a case that
remains unopened in the interim)
– this is a demanding regimen (non-compliance likely!)
– once resealed, the case should be agitated vigorously to ensure fresh solution
bathes all inside surfaces, lid, case/lid threads, etc.

5L1-102
 CONTACT LENS CARE
LONG-TERM STORAGE OF CLs
• An alternative is to use unneutralized 3% peroxide in a new,
vented case with 3-monthly (a conservative figure) scheduled
solution changes
– the same provisos detailed previously apply, especially
ensuring the new solution bathes the insides of the case
completely
– current peroxide solutions are well stabilized and can easily
perform this task (a vented case still required)
 longer storage is possible & safe but scheduling longer
intervals is more difficult
 obviously, CLs require thorough neutralization & rinsing
before further use
• In summary: Discard the CLs – it’s the easiest solution

5L1-103
 CONTACT LENS CARE
IN-OFFICE (TRIAL SET) DISINFECTION
• Similar to all other long-term storage
– problems for GP & hydrogel lenses are similar
– a CL practice must set the standard for infection control
• Disposable CLs have  problem significantly. However, not all trial
CLs are disposable & GP CLs are unlikely to be disposable in the
foreseeable future
• If trial CLs can be disinfected thermally, this is preferred
– prions are not inactivated by heat used in this context
– any CLs used on a known CJD/vCJD case should be
destroyed
– undiagnosed CJD cases are a risk
 there are no known cases of CL-mediated CJD – yet!

5L1-104
 CONTACT LENS CARE
IN-OFFICE (TRIAL SET) DISINFECTION
• Alternatives include:
– peroxide storage in a vented lens case with scheduled 3-monthly solution
changes
 as neutralization takes time, and is required before reuse, it must be
scheduled immediately before any relevant appointment. The latter
can not always be anticipated
– storage in a MPS with 2-weekly solution changes as described previously.
As none of these solutions are especially strong disinfectants, thorough
cleaning & rinsing before storage, and documentation of the steps taken
are mandatory
 as the vial/case/container is likely to be reused many times,
consideration of case hygiene/replacement and/or biofilm formation
are also required
• Although obvious, the need for the case/vial lids to remain on
& sealed needs to be emphasized to all staff in the practice
5L1-105
 CONTACT LENS CARE
SUMMARY

• The need for routine lens care remains essentially the

same as previously

• Contact lenses need to be rubbed during the CL cleaning

step

• It is probable that regulatory requirements for lens care

products will be made more stringent in the near future

• Long-term, the  cost of CLs & the  costs of LCPs will

have to be reconciled

5L1-106
 GP LENS CARE
PRODUCT
PRODUCT UPDATES
UPDATES

Due to research advances and changing market conditions,

new LCP releases and older product retirements are regular
events

IACLE is keen to keep its resources up-to-date. Therefore,

we invite members and other interested parties to inform
IACLE of changes in the LCP marketplace
Please forward information to: iacle@iacle.org

As IACLE’s presentations are electronic resources, they can

be updated easily & promptly

IACLE will inform members of resource updates

5L1-107
 IACLE RESOURCES
ERRORS,
ERRORS, OMISSIONS,
OMISSIONS, IMPROVEMENTS
IMPROVEMENTS

IACLE also invites users of its resources to help it evolve and improve them

If you become aware of errors or omissions, or you have suggestions for

improvements, you are invited to submit them to : iacle@iacle.org for consideration

Contributions incorporated will be acknowledged in the relevant presentation’s

Notes pane(s)

5L1-108
IACLE INDUSTRY SPONSORS

5L1-109
5L1-110
 ALL
REFERENCES
USED

(In alphabetical order)

5L1-111
Abry F et al. (2010) reported in Sivak A (2010), ARVO 2010 Part 2 available at:
http://www.siliconehydrogels.org/meeting_synopsis/index.asp (accessed on 2010-Dec-22).
Bayer S et al. (2004). Effect of rewetting drops use on comfort and protein deposition of silicone hydrogel (Focus Night
and Day) contact lenses. ARVO Abstracts Book Vol. 1: 1575.
Boost M et al. (2010) . Do multipurpose contact lens disinfecting solutions work effectively against non-FDA/ISO
recommended strains of bacteria and fungi? Ophthal Physiol Opt. 30: 12 – 19.
Bowden FW et al. (1989). Patterns of lens care practices and lens product contamination in contact lens associated
microbial keratitis. CLAO J. 15: 49 – 54.
Bright FV et al. (2011). PHMB and PQ-1 impact on a liposome corneal surface membrane model. Invest Ophthalmol Vis
Sci. 52: E-abstract 6491.
Bui TH et al. (2010). Patient compliance during contact lens wear: perceptions, awareness, and behaviour. Eye & CL.
36(6): 334 – 339.
Butcko V et al. (2007). Microbial keratitis and the role of rub and rinsing. Eye & CL. 33(6): 421 – 423.
Carney LG et al. (1990). Do contact lens solutions stand the test of time? II The aging of salines. CL Spectrum. 5(8): 53 -
56.
Carnt N et al. (2010). Contact lens user profile, attitudes and level of compliance to lens care. Cont Lens Ant Eye.
33:183-188.
Chun MW & Weissman BA (1987). Compliance in contact lens care. Am J Optom Physiol Opt. 64: 274 – 278.
Clark G et al. (1994). Microbial contamination of cases used for storing contact lenses. J Infect. 28: 293 - 304.
Claydon BE et al. (1996). A prospective study of non-compliance in contact lens wear. J BCLA. 19(4): 133-140.
Claydon BE et al. (1997). A prospective study of the effect of education on non-compliant behaviour in contact lens wear.
Ophthalmic Physiol Optics. 17(2): 137 - 146.
Collins M (1990). Failure to care for CLs becoming alarming. In: Contact Lenses a supplement to Australian Optometry
Nov.: 11 – 12.
Collins MJ & Carney LG (1986a). Compliance with care and maintenance procedures amongst contact lens wearers.
Clin Exp Optom. 69: 174 – 177.
Collins MJ & Carney LG (1986b). Patient compliance and its influence on contact lens wearing problems. Am J Optom
Physiol Optics. 63: 952 – 956.

5L1-112
Davis LJ (1995). Lens hygiene and care system contamination of asymptomatic rigid gas permeable lens wearers . ICLC.
22: 217 – 221.
Dumbleton KA et al. (2010). Relationship between compliance with lens replacement and contact lens-related problems in
silicone hydrogel wearers. Poster Amer Acad Optom Annual Meeting, San Francisco Nov 2010 .
Efron N et al., (1990). Do in-eye lubricants for contact lens wearers really work? CL Ant Eye. 5: 14 - 19.
Epstein AB (2002) . SPK with daily wear of silicone hydrogel lenses and MPS. CL Spectrum. 17(11): 30.
Gleason WJ (1999). Contact Lens Regulations and Compliance. CL Spectrum. May or visit:
http://www.clspectrum.com/article.aspx?article=&loc=archive%5C1999%5Cmay%5C0599034.htm
Hickson-Curran SB et al. (2010). Making the case for daily disposable contact lenses: patient non-compliance with
storage case hygiene and replacement. Poster Amer Acad Optom Annual Meeting, San Francisco Nov 2010 .
Hind HW (1979). Contact lens solutions: Yesterday, Today, and Tomorrow. CL Forum. 4(100): 17 – 27.
Houang E et al. (2001). Microbial keratitis in Hong Kong: relationship to climate, environment and contact-lens
disinfection. Trans R Soc Trop Med Hyg. 95: 361 - 367.
Houlsby RD et al. (1984). Microbiological evaluation of soft contact lens disinfecting solutions. J Am Optom Assoc. 55(3):
205 – 211.
Jones L, Senchyna M (2007). Soft contact lens solutions review: Part 1 - components of
modern care regimens. Optometry in Practice 8: 45 - 56.
Kilvington S (2000). Through a glass darkly – Contact lenses and personal hygiene. Microbiol Today. 27(5): 66 – 69.
Ky W et al. (1998). Clinical survey of lens care in contact lens patients. 24(4): 216 – 219 & comment 194.
Lakkis C et al. (2010) reported in Sivak A (2010), ARVO 2010 Part 2 available at:
http://www.siliconehydrogels.org/meeting_synopsis/index.asp (accessed on 2010-Dec-22).
Larragoiti ND et al. (1994). A comparative study of techniques for decreasing contact lens storage case contamination . J
Am Optom Assoc. 65(3): 161 – 163.
Leluan P et al. (1991). Amoebic and bacterial contamination of contact lens storage cases. Contactologia 13: 137 – 141.
Mayers M et al. (2010). Compliance and contamination in contact lens wear. Poster Amer Acad Optom Annual Meeting,
San Francisco Nov 2010 .
McGeehon M (1988). Guidelines to handling problem patients. CL Forum. 13(4): 23 – 28.
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5L1-113
Morgan PB et al. (2011). International Contact Lens Prescribing in 2010. CL Spectrum. January 2011. Available at:
http://www.clspectrum.com/article.aspx?article=105084
Peterson R et al. (2010). Impact of a rub and rinse on solution-induced corneal staining. Optom Vis Sci. 87: 1030 – 1036.
Powell CH et al. (2010). ARVO Fort Lauderdale, May 2010. Synopsis by Sivak A Oct 2010 Meeting Synopsis on the
silicone hydrogels website (www.siliconehydrogels.org)
Radford CF et al. (1993). Contact lens hygiene compliance in a university population. J BCLA. 16(3): 105 – 111.
Seal D et al. (1999). Acanthamoeba keratitis in Scotland: Risk factors of contact lens wearers. Cont Lens Ant Eye. 22(2):
58 - 68.
Schwartz CA (1987). What’s on their minds when they don’t comply? Review Optom. 130: 49.
Shannon BJ (1987). Don’t quit with the fit. CL Forum. 12: 46 – 48.
Shih KL et al. (1985). The microbial benefit of cleaning and rinsing contact lenses. ICLC. 12(4): 235 – 242.
Shih KL et al. (1991). Disinfecting activities of non-peroxide soft contact lens cold disinfection solutions. CLAO J. 17(3):
165 – 168.
Sokol JL et al. 1990. A study of patient compliance in a contact lens wearing population. CLAO J. 16(3): 209 – 213.
Stapleton F et al. (1995a). Epidemiology of Pseudomonas aeruginosa keratitis in contact lens wearers. Epidemiol Infect.
114(3): 395 – 402.
Stone R (1988). Why contact lens groups? CL Spectrum. 3: 38 - 41.
Sweeney DF et al. (1992). Contamination of 500 ml bottles of unpreserved saline. Clin Exp Optom. 75(2): 67 – 75.
Tonge et al. (2001). Contact lens care: Part 6: - Comfort drops, artificial tears and dry-eye therapies. Optician 222(5817):
27 – 33.
Turner FD et al. (1993). Compliance and contact lens care: A new assessment method. Optom Vis Sci. 70(12): 998 –
1004.
Wilson LA et al. (1990). Microbial contamination of contact lens storage cases and solutions. Am J Ophthalmol. 110: 193
- 198.
Wilson LA et al. (1991). Comparative Efficacies of Soft Contact Lens Disinfectant Solutions Against Microbial Films in
Lens Cases. Arch Ophthalmol 109: 1155 – 1157.
Woods CA et al. (2010). Compliance with lens care and contact lens case care and replacement. Poster Amer Acad
Optom Annual Meeting, San Francisco Nov 2010 .

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 CONTACT LENS CARE
PRESERVATION STANDARDS

ISO 14730: Preservative Efficacy Test (tests effectiveness up to 30 days, no CLs involved,
microbial re-challenge @ 14 days, tests for initial efficacy & shelf-life. Test is basis of 30-day
lens storage)
Test Panel (TP) of Organisms (inoculum 1 X 10 7 to X 108 CFU/mL):
• Fungi:

– Candida albicans ATCC 10231

– Aspergillus niger ATCC 16404
• Bacteria:
– Pseudomonas aeruginosa ATCC 9027
– Staphylococcus aureus ATCC 6538
– Escherichia coli ATCC 8739

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 CONTACT LENS CARE
PRESERVATION CRITERIA
ISO 14730: Performance Requirement (inoculum 107 to 108)
Bacteria A preservative acts as a
• At 14 days & before re-challenge LCP ‘defence system’

–  by a mean value of 3 log of TP bacteria

• After the 14 day re-challenge, assessed at day 28
  by a mean value of 3 log of TP bacteria
Molds & Yeasts
Return to
• At 14 days & before re-challenge DISINFECTION
– the number of organisms recovered per mL is equal to or fewer
than initial numbers (error allowed  0.5 log)
• After the 14 day re-challenge, assessed at day 28
– the numbers to remain at or below level after the re-challenge
(error allowed  0.5 log)

These criteria to be met throughout labeled shelf-life

5L1-116
 CONTACT LENS CARE
A BRIEF HISTORY 0

• Early glass scleral CLs maintained with soap & water

• Glass-PMMA hybrid sclerals & early PMMA corneal lenses (early 1940s) used
with sodium bicarbonate (NaHCO3) solution to try to address corneal oedema
not lens condition (Hind, 1979)
• First true LCPs addressed lens wettability, not cleanliness. Many contained
polyvinyl alcohol (PVA). It was then realized that other factors such as
soiled/deposited lens surfaces also affected lens wettability. Lens cleaners
followed & modern lens care was born
• Eventually, suites of LCPs that cleaned, disinfected, and
wet PMMA lenses became available from several manufacturers

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A BRIEF HISTORY 1
• Thermal disinfection used on the first HEMA SCLs (1950s):
– lens case immersed in boiling water
– denaturation of tear protein induced adverse reactions/hypersensitivity
– lens deposits  comfort &  lens life
– eventually, enzymatic protein removal treatments addressed these issues
partially
– still the cheapest & most effective antimicrobial treatment but prions
remain effective
– later, automatic electric wet, and later still, electric dry heat units were
developed deploying lower temperatures (70-85°C) to reduce
denaturation
– still applicable to HEMA trial (diagnostic) lenses

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A BRIEF HISTORY 2

• Hydrogen peroxide disinfection was introduced when non-

HEMA SCLs (45-55% water initially, later 79 - 85%)
appeared on the market:
– initially, pharmacy grade 3% peroxide used but variable
quality & stabilizers used in some, led to unwanted
discolouration & physical property changes
– effective neutralization an issue (See notes)

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A BRIEF HISTORY 3
• Next were the so-called cold chemical systems in which CLs (rigid & soft) were
immersed after cleaning & rinsing:
– disinfectants used included: mercurials (e.g. thimerosal), chlorhexidine (a
biguanide, e.g. chlorhexidine gluconate), quaternary ammonium compounds or
QACs (e.g. ATAC or ATEAC)
– a common excipient then & now was EDTA. Later, benzalkonium chloride (BAK –
rigid lens only), sorbic acid, chlorbutanol (an alcohol), benzyl, ethyl, & isopropyl
alcohols were also used
 initially, EDTA included as a disinfectant/preservative enhancer, later its
calcium-chelating properties were also harnessed
– adverse reaction rates to individual ingredients or combinations of ingredients
were significant especially in hydrogel wearers. Research resulted in the evolution
of the modern polymeric biguanides & QACs that now underpin the majority of
non-peroxide LCPs

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A BRIEF HISTORY 4
• Chlorine–based systems have appeared & disappeared
– usually in tablet form, these products proved to be less efficacious
than desired, e.g. they were less effective against fungi &
Acanthamoeba spp. [especially encysted])
– efficacy was  by chlorine’s predilection for binding to biological soil,
hence removing it from solution
– they were simple & economic
• A chlorhexidine-based tablet system was introduced but the ocular
reaction rate to the product limited its marketability
• UV-generating (usually UV-C), ozone generating, & microwave oven-
based disinfection systems have also appeared. Few remain

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A BRIEF HISTORY 5

• Modern MPSs are based on polymeric biguanides, polymeric

QACs, or more recently, both. Their large molecular structure
deters accumulation within intact hydrogel or SiHy CLs   eye
exposure to man-made chemical entities
– most non-peroxide lens care systems are based on
polihexanide (PHX, PAPB, PHMB [polymeric biguanides]) or
polyquaternium-1 (PQ-1 or polidronium chloride – a polymeric
QAC), or a combination of these
– antimicrobial efficacy of MPSs is also something of a
compromise – a balance of efficacy & toxicity

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A BRIEF HISTORY 6
• Chemically, peroxide systems have changed little over time
– most are now 1-step (tablet or disc)
• A sodium chlorite-hydrogen peroxide disinfectant & a sodium chlorite
preserved (a so-called ‘disappearing preservative’) series of in-eye
products round out the current LCP market
• Other additions include anti-acanthamoebal compounds (e.g. MAPD).
Such inclusions can be expected to become more common in future
LCPs
• EDTA is still a common inclusion in LCPs
• Many solutions, especially cleaners, still include viscosity-increasing
agents

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A BRIEF HISTORY 7
Why have some products survived? Possibilities include:
• Success at balancing efficacy & toxicity, i.e. product is effective against micro-
organisms & relatively ineffective against the anterior eye
• Strong marketing of an acceptable product
• Availability of starter kits at little or no cost. However, unpublished studies have
shown that even free kits do not necessarily ensure market penetration/success
• Competitive pricing of an acceptable product
– intuitively, nothing will save an unacceptable product. Sometimes however,
‘failure’ takes time
• Addressing a niche market that is unattractive to competitors (often due to small
size or highly specialized nature)
• Adequate & relevant market research used to steer product development
• Luck – having the right (appropriate) product at the right time

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A BRIEF HISTORY 8
Why have some products failed? Possibilities include:
• Failure to balance efficacy & toxicity
• Poor marketing of an acceptable product
• Uncompetitive pricing of an acceptable product
• Addressing a niche market that is too small to be sustained
• Inadequate and/or poorly targeted market research used to steer product
development
• Failure to ‘move with the times’ – product(s) perceived as ‘old’
• Inadequately researched product
• Failure to take ‘worst case scenarios’ into account, e.g. user non-compliance
• Unforeseen changes in external factors, e.g. reticulated mains water disinfection
levels, that alter the anticipated user environment
• Bad luck

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