Report of the Epidemiology Subcommittee Members: Kathy Dumbleton (Chair)

1. Report of the Epidemiology Subcommittee Members: Kathy Dumbleton (Chair) Christine Purslow (SC Liaison) Murat Dogru (Consultant) Barbara Caffery Sheila Hickson-Curran Jami Kern Takashi Kojima Philip B. Morgan Danielle M. Robertson J. Daniel Nelson (Harmonization Subcommittee Member)

2. Epidemiology Subcommittee • Scope of Epidemiology Report • To provide a clinical context of CLD • Differentiate from dry eye that can occur in CL and non CL wearers • To report on the prevalence of CLD • To investigate the factors associated with CLD • To examine the impact of CLD • To consider future research directions for evaluating the epidemiology of CLD WHO Definition of Epidemiology: “The study of the distribution and determinants of health-related states or events (including disease), and the application of this study to the control of diseases and other health problems.”1

3. Epidemiology Subcommittee • Caveats • Emphasis of CLD as a symptom not a sign • Disregard CLD due to attributable pathophysiology • Primarily CLD with adapted wear of disposable soft lenses • Not adaptation to CLs

4. Epidemiology Subcommittee • Contact Lens Discomfort (CLD): Historical Context • PubMed search: • 7,024 publications with “contact lens” in title/abstract • 406 with “contact lens” and “(dis)comfort” • 1970s – 2.6% of CL papers • 2000 onwards – 7.5% of CL papers • 1980s and 1990s • Frequency and types of CLD and related symptoms • Last 15 years • Determinants of CLD • CL hydration and dehydration, tear film, lens design, lens material, replacement frequency, care system etc. Note: Complete list of references provided in Epidemiology report

5. Epidemiology Subcommittee • Clinical Context • Symptoms - “Discomfort” is generic term • Patients may describe other specific symptoms • Dryness symptoms • McMonnies and Ho 1986 2 • CL wear provocative factor in “marginal dry eye” • Other symptoms • Stinging, burning, itching, lens awareness, grittiness, scratchiness, visual disturbance, tiredness, ‘temperature change’ Neurobiology of Discomfort and Pain Subcommittee

6. Epidemiology Subcommittee • Clinical Context (cont’d) • Signs • Clinical assessments which may be helpful: • Pre-lens tear film • Meibomian glands • Eyelids • Bulbar hyperemia • Corneal and conjunctival staining • Young et al 2012 3 • NO common sign in symptomatic wearers • 23% of symptomatic wearers did not exhibit any of the typical clinical signs of dryness

7. Epidemiology Subcommittee • Prevalence • Population Based Studies • PubMed search • “Contact lens discomfort” and “population study” or “epidemiological study” • No prospectively designed epidemiological studies • Only epidemiological studies to investigate prevalence of dry eye disease • Older populations, CL wear infrequently reported • 5 population based studies dry eye studies reporting on CL wearers • Canada (1), Japan (3) and China (1) • May be differences according to geographical location

8. Epidemiology Subcommittee • Prevalence: Population Based Studies

9. Epidemiology Subcommittee • Prevalence • Clinical Studies • Broader extent of CLD research • Clinical practice • Hospitals • Disadvantages • Issues with sampling • Bias in control groups • Survivor effects etc. • 14 clinical studies reporting on prevalence of CLD

10. Epidemiology Subcommittee • Prevalence: Clinical Studies (1)

11. Epidemiology Subcommittee • Prevalence: Clinical Studies (2)

12. Epidemiology Subcommittee • Summary of Frequency of CLD • Reported to range from ≈ 30 – 80% • Approximately 50% • Variations may be attributed to: • Population evaluated • Questionnaires used • Symptoms evaluated • CL types • Care solutions

13. Epidemiology Subcommittee • Factors Associated with CLD • Patient related factors • Non modifiable • Gender • Age • Poor tear film quality / quantity • Blinking (rate and completeness) • Systemic disease • Seasonal allergies • Ethnicity • Modifiable • Medication • Compliance with lens replacement • Diet / hydration / alcohol intake • Smoking • Cosmetics • Psychological / fatigue

14. Epidemiology Subcommittee • Factors Associated with CLD • Factors secondary to lens wear • Decreased tear film thickness and stability • Increased tear osmolarity • Loss or shortening of meibomian glands • Alterations in corneal sensitivity • Cellular changes in corneal and conjunctival epithelia Contact Lens Interactions with the Ocular Surface and Adnexa Subcommittee Contact Lens Interactions with the Tear Film Subcommittee

15. Epidemiology Subcommittee • Factors Associated with CLD • Environmental Factors • Low humidity • Temperature • Climate • Pollution and air quality • Occupation • Air conditioning and heating • Altitude / atmospheric pressure • Factors related to contact lenses and care regimens Contact Lens Materials, Design and Care Subcommittee

16. Epidemiology Subcommittee • Impact or Morbidity of CLD • Patient • “Quality of Life” • Interference with daily activities emotional effects • Economic • Lens and lens care products, visits to ECP etc. • “Drop out” • Prichard et al 23 – Canada 1999 • 1,400 wearers: 34% discontinued • Dumbleton et al 24 – Canada 2013 • 4207 wearers: 40% lapsed lens wear

17. Epidemiology Subcommittee • Impact or Morbidity of CLD (cont’d) • ECP • Increased chair time • Patient retention • ≈ 3 million discontinue each year in US • Economic • Contact Lens Industry • Product technology advances • Direct comparisons required to decisively establish significant improvement • Contact lens market • Relatively flat growth

18. Epidemiology Subcommittee • Future Research Directions • Epidemiological studies • Natural occurrence and evolution of CLD • Geographical, racial and gender differences • Prospective clinical trials • Effect of modifying one parameter at a time • Requires commitment from industry • Non-interventional or registration trials • Power derived from large numbers • Statistical modeling to determine relationship between CLD and lens-related factors • Adoption of a single measure of CLD

19. Epidemiology Subcommittee • Acknowledgements • The Tear Film & Ocular Surface Society • CLD Steering Committee • Epidemiology Subcommittee on CLD • Sponsors • Alcon, Allergan, Bausch + Lomb, Contact Lens Spectrum, Cooper Vision, Menicon, Oculus, Optima, Santen, Laboratoires Théa, Vistakon

20. Epidemiology Subcommittee • Unknown. World Health Organization: Epidemiology. Accessed 23rd Feb 2013http://www.who.int/topics/epidemiology/en • McMonnies CW, Ho A. Marginal dry eye diagnosis: history versus biomicroscopy. In: Holly F (ed), The Preocular Tear Film in Health, Disease and Contact Lens Wear. Lubbock, TX: Dry Eye Institute; 1986:32-40. • Young G, Chalmers R, Napier L, Kern J, Hunt C, Dumbleton K. Soft contact lens-related dryness with and without clinical signs. Optom Vis Sci 2012;89:1125-1132. • Doughty MJ, Fonn D, Richter D, Simpson T, Caffery B, Gordon K. A patient questionnaire approach to estimating the prevalence of dry eye symptoms in patients presenting to optometric practices across Canada. Optom Vis Sci 1997;74:624-631. • Uchino M, Nishiwaki Y, Michikawa T, et al. Prevalence and risk factors of dry eye disease in Japan: Koumi study. Ophthalmology 2011;118:2361-2367. • Uchino M, Schaumberg DA, Dogru M, et al. Prevalence of dry eye disease among Japanese visual display terminal users. Ophthalmology 2008;115:1982-1988. • Uchino M, Dogru M, Uchino Y, et al. Japan Ministry of Health study on prevalence of dry eye disease among Japanese high school students. Am J Ophthalmol 2008;146:925-929 e922. • Zhang Y, Chen H, Wu X. Prevalence and risk factors associated with dry eye syndrome among senior high school students in a county of Shandong Province, China. Ophthalmic Epidemiol 2012;19:226-230. • Brennan NA, Efron N. Symptomatology of HEMA contact lens wear. Optom Vis Sci 1989;66:834-838. • Guillon M, Styles E, Guillon JP, Maissa C. Preocular tear film characteristics of nonwearers and soft contact lens wearers. Optom Vis Sci 1997;74:273-279. • Vajdic C, Holden BA, Sweeney DF, Cornish RM. The frequency of ocular symptoms during spectacle and daily soft and rigid contact lens wear. Optom Vis Sci 1999;76:705-711. • Begley CG, Caffery B, Nichols KK, Chalmers R. Responses of contact lens wearers to a dry eye survey. Optom Vis Sci 2000;77:40-46.

21. Epidemiology Subcommittee • Begley CG, Chalmers RL, Mitchell GL, et al. Characterization of ocular surface symptoms from optometric practices in North America. Cornea 2001;20:610-618. • Chalmers RL, Begley CG. Dryness symptoms among an unselected clinical population with and without contact lens wear. Cont Lens Anterior Eye 2006;29:25-30. • Du Toit R, Situ P, Simpson T, Fonn D. The effects of six months of contact lens wear on the tear film, ocular surfaces, and symptoms of presbyopes. Optom Vis Sci 2001;78:455-462. • Guillon M, Maissa C. Dry eye symptomatology of soft contact lens wearers and nonwearers. Optom Vis Sci 2005;82:829-834. • Nichols JJ, Ziegler C, Mitchell GL, Nichols KK. Self-reported dry eye disease across refractive modalities. Invest Ophthalmol Vis Sci 2005;46:1911-1914. • Nichols JJ, Sinnott LT. Tear film, contact lens, and patient factors associated with corneal staining. Invest Ophthalmol Vis Sci 2011;52:1127-1137. • Riley C, Young G, Chalmers R. Prevalence of ocular surface symptoms, signs, and uncomfortable hours of wear in contact lens wearers: the effect of refitting with daily-wear silicone hydrogel lenses (senofilcon a). Eye Contact Lens 2006;32:281-286. • Richdale K, Sinnott LT, Skadahl E, Nichols JJ. Frequency of and factors associated with contact lens dissatisfaction and discontinuation. Cornea 2007;26:168-174. • González-Méijome JM, Parafita MA, Yebra-Pimentel E, Almeida JB. Symptoms in a population of contact lens and noncontact lens wearers under different environmental conditions. Optom Vis Sci 2007;84:E296-E302. • Young G, Chalmers RL, Napier L, Hunt C, Kern J. Characterizing contact lens-related dryness symptoms in a cross-section of UK soft lens wearers. Cont Lens Anterior Eye 2011;34:64-70. • Pritchard N, Fonn D, Brazeau D. Discontinuation of contact lens wear: a survey. Int Contact Lens Clin 1999;26:157 - 162. • Dumbleton K, Woods CA, Jones LW, Fonn D. The impact of contemporary contact lenses on contact lens discontinuation. Eye Contact Lens 2013;39:92-98.

22. Epidemiology Subcommittee Thank you! QUESTIONS?