Current Research Topics in Cornea & CLs. Discomfort. Reasons for Dropout. Financial Disclosure 8/27/2017. Lyndon Jones PhD FCOptom FAAO

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1 Financial Disclosure Current Research Topics in Cornea & CLs Lyndon Jones PhD FCOptom FAAO Professor and University Research Chair School of Optometry & Depts of Physics, Biology, Chemical Engineering & Chemistry Director,, University of Waterloo, Ontario, Canada Over the past three years members of the CCLR have received research funding and/or honoraria from the following companies: Advanced Vision Research Alcon Allergan Contamac CooperVision Essilor GL Chemtec Inflamax Research Johnson & Johnson Vision Nature s Way Novartis Ocular Dynamics Oculus Safilens Santen Shire TearLab TearScience Discomfort % of Wearers Dropping out of Lens Wear for a Period of Time Reasons for Dropout Weed 1993 Canada Pritchard 1999 Dumbleton 2013 UK Best 2013 Richdale 2007 US Nichols 2010 Rumpakis Sulley et al: Factors in the success of new contact lens wearer retention. Optom Vis Sci 2014; 91 e-abstract

2 N=4207 Reasons for Lapsed Wear Tear Film & Ocular Surface Society Factors impacting CLD Contact Lens Discomfort 9 subcommittees 79 experts Academic and industry representatives Oct 2013: publication in IOVS 10 reports All free to download Dumbleton et al.: The impact of contemporary contact lenses on contact lens discontinuation. Eye Contact Lens 2013; 39;1: Many factors influence comfort in CL wearers TFOS Reports on CLD Patient factors: Demographics Age Gender Environment Humidity Temperature General Health Allergies Diet Medications Systemic conditions Ocular Physiology Lid margin disease Ocular surface Tear film Care regimen factors: Disinfecting solutions Rewetting drops Lens factors: Design and fit Deposition Material Dk/t Lubricity Hydration Modulus Wettability Surface properties Modification Wetting agents Wearing schedule Modality Replacement frequency Wearing time 1. Dumbleton et al.: The TFOS International Workshop on Contact Lens Discomfort: Report of the Subcommittee on Epidemiology. Invest Ophthalmol Vis Sci 2013; 54;11: TFOS Jones et al.: The TFOS International Workshop on Contact Lens Discomfort: report of the contact lens materials, design, and care subcommittee. Invest Ophthalmol Vis Sci 2013; 54;11: TFOS Papas et al.: The TFOS International Workshop on Contact Lens Discomfort: Report of the Management and Therapy Subcommittee. Invest Ophthalmol Vis Sci 2013; 54;11: TFOS Oxygen Permeability (Dk) Materials Dk (barrers) Tighe, 2000 Conventional Sil Hydrogel Equilibrium Water Content (%) 2

3 AO Night & Day Ultra Biofinity Dailies TOTAL1 Acuvue OASYS/VITA Air OPTIX Aqua PureVision 2 1-Day AV OASYS 1-Day AV TruEye Sapphire/Avaira Vitality MyDay Acuvue Advance Clariti 1 day Biotrue 1 Day Proclear Dailies ACP 1 Day AV Moist Acuvue 2 Proclear 1 Day SofLens 38 Oxygen Transmissibility (Dk/t) ( 3.00D) Hydrogel Dk/t 1. SiHy values from manufacturers quoted values. 2. Hydrogel values calculated from Morgan & Efron. The oxygen performance of contemporary hydrogel contact lenses. CLAE 1998;21: SiHy Oxygen Transmissibility (Dk/t) Centre of a 3.00D lens what about the periphery? What about impact of thickness? BVP vs 4.00D torics bifocals Characteristics of Reusable SiHy Materials SiHy Daily Disposable Characteristics of DD SiHy Materials DAILIES TOTAL1 Unique water gradient technology ultra-soft surface gel Low friction surface 3

4 Silicone Hydrogel Benefits What have SiHy bought us? Hypoxia related complications - problem solved! overnight oedema ~3% 1,2 no increase in microcysts 2,3 min limbal hyperaemia 2,4 min vascularisation 5 no myopic creep 6 1. Fonn D et al.: IOVS 1999; 40;13 2. Fonn D et al.: Clin Exp Optom 2002; 85;3 3. Covey M et al.: OVS 2001; 78;2 4. Papas E et al.: Curr Eye Res 1997; 16;9 5. Dumbleton KA et al. OVS 2001; 78;3 6. Dumbleton KA et al. OVS 1999; 76;12 Corneal Swelling for DW? Hydrogel Wear vs NLW Moezzi et al.: Corneal swelling with cosmetic etafilcon A lenses versus no lens wear. Optom Vis Sci 2016; 93;6: N=24 DW of etafilcon A for 8 hrs (tinted and clear) Central and peripheral corneal swelling by optical pachymetry or OCT was negligible No significant differences between lenses and NLW for corneal staining limbal/bulbar hyperemia Comfort & Wearing Time SiHy & DD Only Comfort Benefits? N=2232 Hours of Wear Comfort During Wear 14 Reduced Good Canada USA K Dumbleton et al: Compliance with contact lens replacement in Canada and the United States. Optom Vis Sci 2010; 87(2):

5 Comfort: Hydrogel vs SiHy? Comfort: Hydrogel vs SiHy? there is no evidence that for daily wear they have significantly improved comfort compared with the comfort achieved with hydrogel contact lenses While it may be appealing to attribute measured comfort benefits to the higher oxygen transmissibility of the SiHy lenses, a host of other confounding factors will drive the comfort response. for the outcomes achieved M Guillon: Are silicone hydrogel contact lenses more comfortable than hydrogel contact lenses? Eye Contact Lens 2013; 39;1: Jones et al.: The TFOS International Workshop on Contact Lens Discomfort: report of the contact lens materials, design, and care subcommittee. Invest Ophthalmol Vis Sci 2013; 54;11: TFOS Material Factors NOT Associated with Comfort Higher Dk/t Ionicity/charge Modulus/stiffness Dehydration In vitro wettability Tear exchange Deposits denatured lysozyme? Material Factors PROBABLY Associated with Comfort Good fit avoid excessive movement avoid excessive thickness Lower water content Shorter frequency of replacement Shorter periods of wear comfort worse at end of day Low friction Jones et al.: The TFOS International Workshop on Contact Lens Discomfort: report of the contact lens materials, design, and care subcommittee. Invest Ophthalmol Vis Sci 2013; 54;11: TFOS Jones et al.: The TFOS International Workshop on Contact Lens Discomfort: report of the contact lens materials, design, and care subcommittee. Invest Ophthalmol Vis Sci 2013; 54;11: TFOS Friction & Lubricity Emerging importance to CL field varied testing protocols unknown which best simulates in-eye performance Recent evidence does exist for an association between CL friction and comfort 1,2 What are some unique challenges with SiHy? 1. Coles & Brennan: Coefficient of friction and soft contact lens comfort. Optom Vis Sci 2012; 88:e-abstract Kern et al: Assessment of the relationship between contact lens coefficient of friction and subject lens comfort. Invest Ophthalmol Vis Sci 2013; 54:(ARVO abstracts):e-abstract

6 1. Modulus Modulus (MPa) Modulus Acuvue Proclear Advance Clariti TruEye OASYS Biofinity Air Optix PureVision Night & Day Water Content vs Modulus 2. Deposits Deposit Summary for SiHy Very low levels of protein but often denatured Lipid deposits higher than conventional materials in some patients lower in surface treated materials Clinical relevance not all deposits may be bad? denatured protein and lipid is hard to remove without physical rub/rinse 3. Interactions With Solutions 6

7 Biocide Uptake/Release? Corneal Other Pictures Staining 1. CH Powell et al:, CLAE 2010; 33: Lipophilic versus hydrodynamic modes of uptake and release by contact lenses of active entities used in multipurpose solutions. Cont Lens Anterior Eye 2010; 33;1: L Jones & CH Powell: Uptake and release phenomena in contact lens care by silicone hydrogel lenses. Eye Contact Lens 2013; 39;1: Clinically Relevant? Review Papers on Staining Fluorescein Interacts With MPS Preservatives When fluorescein dye is applied to the eye, it interacts with MPS preservatives released from soft contact lenses 1,2 Fluorescein (negative charge) and MPS preservatives (positive charge) are attracted to one another 1-8 The level of attraction depends on MPS preservative 2 Fluorescein Preservative Fluorescein is attracted to PHMB up to 50x more strongly than to PQ Morgan et al. Corneal staining: do we really understand what we are seeing? Cont Lens Anterior Eye 2009; 32;2: Ward. Superficial punctate fluorescein staining of the ocular surface. Optom Vis Sci 2008; 85;1: MPS = multipurpose solution; PHMB = polyhexamethyl biguanide; PQ-1 = polyquaternium Bright FV et al. Poster presented at: The 6 th Biennial Scientific Symposium of the Contact Lens Association of Ophthalmologists Education and Research Foundation; September 23-25, 2010; Las Vegas, NV. 2. Data on File. Bausch & Lomb, Inc Blackburn RS et al. Langmuir. 2006;22: Dutot M et al. Eur J Pharm Sci. 2008;33: Kilvington S et al. Antimicrob Agents Chemother. 2002;46: Labbe A et al. J Ocular Pharmacol Ther. 2006;22: Perez-Ruiz T et al. Chromatographia. 1998;48: Powell CH et al. Cont Lens Anterior Eye. 2010;33:9. [ 40 ] Latest Findings Case Hygiene Replace case regularly every 1/12 ideal max after 3/12 Rubbing with a tissue reduces biofilm Don t air dry face-up aerosol effect Air dry face-down on a clean tissue 1. Wu YT, Zhu H, et al.: Impact of air-drying lens cases in various locations and positions. Optom Vis Sci 2010; 87;7: Wu YT, Zhu H, et al.: The effectiveness of various cleaning regimens and current guidelines in contact lens case biofilm removal. Invest Ophthalmol Vis Sci 2011; 52;8: Wu YT, Zhu H, et al.: Profile and Frequency of Microbial Contamination of Contact Lens Cases. Optom Vis Sci 2011; In press. 4. Wu YT, Teng YJ, et al.: Impact of lens case hygiene guidelines on contact lens case contamination. Optom Vis Sci 2011; 88;10: E

8 year data on MK Rates for EW SCL 4. Microbial Keratitis Annual Incidence (per 10,000) Hydrogel Si Hydogel Severe keratitis? Hydrogel ~ SiHy USA 1989 USA 1991 Sweden 1994 Holland 1999 Hong Kong 2002 UK 2005 USA 2005 Australia 2008 EW SiHy & Microbial Keratitis No reduced incidence compared with conventional polyhema-based materials Lower morbidity Swifter recovery role of oxygen? Related to eye/lens contamination with pathogenic organisms 5. Infiltrative Keratitis Schein et al, 2005, Keay et al OVS 2006, Stapleton et al, 2008 Infiltrates? Difficult to accurately report incidence rates results depend on: study design criteria used for reporting infiltrates Consistently 2X higher rate with reusable SiHy 1-5 Hydrogels vs SiHy SiHy materials have provided muchneeded improved oxygen transport to the eye but little improvement in comfort for many patients Hydrogels remain a viable option for many wearers 1. Szczotka Flynn & Diaz Optom Vis Sci 2007; 2.Radford et al Ophthalmology 2009; 3. Chalmers et al Optom Vis Sci 2010; 4. Chalmers et al IOVS 2011; 5. Chalmers et al Optom Vis Sci

9 Impact of Solutions on CLD Solutions There are conflicting studies regarding the impact of solutions on CLD 1,2 No statistically significant association for solutions in self-reported DE among CL wearers 3 1. Papas et al.: The TFOS International Workshop on Contact Lens Discomfort: Report of the Management and Therapy Subcommittee. Invest Ophthalmol Vis Sci 2013; 54;11: TFOS Jones et al.: The TFOS International Workshop on Contact Lens Discomfort: report of the contact lens materials, design, and care subcommittee. Invest Ophthalmol Vis Sci 2013; 54;11: TFOS Ramamoorthy et al.: Treatment, material, care, and patient-related factors in contact lens-related dry eye. Optom Vis Sci 2008; 85;8: Comfort: Lens & Solution Choice? Comfort: Avoiding Solutions.. D Tilia et al: Effect of lens and solution choice on the comfort of contact lens wearers. Optom Vis Sci 2013; 90;5: Ocular comfort and symptoms in symptomatic CL wearers can be perceptibly improved by switching to an alternative CL-LCP combination. This finding provides justification for the efforts of both eye care practitioners and researchers to improve the comfort of CL wearers Senofilcon A clinical response is modulated by the lens care products. All lens care products tested reduced subjective responses relative to DD modality,... Senofilcon A performs best when used on a DD basis. P Lazon de la Jara et al: Effect of lens care systems on the clinical performance of a contact lens. Optom Vis Sci 2013; 90;4: Potential Patient Factors? Patient Factors Age Environment Medication Allergies Blink rate Tear film quality Lid disease 9

10 Patient Factors Associated with CLD Potential factors include: Female sex Younger age Poor TF quality and quantity Seasonal allergies Some systemic medications oral contraceptives isotretinoin Diet, hydration & alcohol Smoking Compliance Dumbleton et al. The TFOS International Workshop on Contact Lens Discomfort: Report of the Subcommittee on Epidemiology. Invest Ophthalmol Vis Sci 2013; 54;11: TFOS Ocular Surface Factors Associated with CLD Potential factors include: Staining bulbar conjunctival staining corneal staining Lid abnormalities meibomian gland disease lid wiper epitheliopathy Tear film abnormalities reduced tear film stability increased tear film evaporation tear film biochemical changes mainly to lipids 1. Craig et al: The TFOS International Workshop on Contact Lens Discomfort: Report of the Contact Lens Interactions With the Tear Film Subcommittee. Invest Ophthalmol Vis Sci 2013; 54;11: TFOS Efron et al: The TFOS International Workshop on Contact Lens Discomfort: Report of the Contact Lens Interactions With the Ocular Surface and Adnexa Subcommittee. Invest Ophthalmol Vis Sci 2013; 54;11: TFOS98-TFOS122. Meibomian Gland Dysfunction Lid Disease Bubbles in the tear film Association of MGD with CL Wear? Impact of MGD on CL Discomfort? Equivocal results CL wear reduces # of functional MG 1 decrease is proportional to duration of CL wear No association between CL wear and MG atrophy 2 CL wear results in MG changes 3 Onset during first 2 yrs of wear 6 months cessation of wear no impact on recovery 1. Arita et al.: Contact lens wear is associated with decrease of meibomian glands. Ophthalmology 2009; 116;3: Pucker et al.: Associations with meibomian gland atrophy in daily contact lens wearers. Optom Vis Sci 2015; 92;9: e Alghamdi et al.: Impact of duration of contact lens wear on the structure and function of the meibomian glands. Ophthalmic Physiol Opt 2016; 36;2:

11 Managing MGD Ocular lubricants containing lipids Warm compresses Physical treatments Forceful expression without heat Intense pulsed light (IPL) Intraductal (Maskin) probing Lid debridement LipiFlow Lid heated and physically expressed Demodex CL Wear and Demodex Impact of Demodex on CL Discomfort? N=62 28 ex CL wearers; ceased wear due to discomfort 34 asymptomatic CL wearers Mean age 29 Significant difference in % exhibiting demodex infestation Percentage of Subjects Demodex No demodex Drop outs 6 Asymptomatic Tarkowski et al. Demodex sp. as a potential cause of the abandonment of soft contact lenses by their existing users. Biomed Res Int 2015;2015: Tea Tree Oil (TTO) Treatment Managing Demodex Blepharitis Tea tree oil (TTO) essential oil derived mainly from the Australian native plant Melaleuca alternifolia TTO is incorporated as the active ingredient in many topical formulations used to treat cutaneous infections wide ranging antimicrobial, antifungal and anti-inflammatory properties TTO kills Demodex mites dosedependently TTO in its pure form can be extremely irritating to the skin around the eye Carson et al (2006). Melaleuca alternifolia (Tea Tree) Oil: a Review of Antimicrobial and Other Medicinal Properties. Clin Microbiol Rev 19(1): 5-62) 11

12 Essential Fatty Acids & Dry Eye Reviews Optics & Optical Correction 1. Roncone et al. Contact Lens & Anterior Eye 2010; 33: Rosenberg & Asbell. The Ocular Surface 2010; 8; 1 (18-28). 3. Rand & Asbell: Curr Opin Ophthalmol 2011; 22: Reviews on Myopia Control Ortho-K vs Atropine/SCL MF for Myopia Control 1. Walline et al: Interventions to slow progression of myopia in children. Cochrane Database Syst Rev 2011;12: CD Smith & Walline: Controlling myopia progression in children and adolescents. Adolesc Health Med Ther 2015; Gifford & Gifford: The Future of Myopia Control Contact Lenses. Optom Vis Sci 2016; 93;4: Walline: Myopia Control: A Review. Eye Contact Lens 2016; 42;1: 3-8. Smith & Walline: Controlling myopia progression in children and adolescents. Adolesc Health Med Ther 2015; 6: Scleral lenses 2. Corneal Cross Linking 3. Refractive Surgery Thanks for your attention 12