1. Report of the Management & Therapy Subcommittee Members: Eric Papas, Chair (Australia) Joseph Ciolino (US) Deborah Jacobs (US) William Miller (US) Heiko Pult (Germany), Afsun Sahin (Turkey) Sruthi Srinivasan (Canada) Joseph Tauber (US) James Wolffsohn (UK) J Daniel Nelson (US - Harmonization Subcommittee Member)

2. General Approach – Provide a clinical framework for treating an individual complaining of CLD – Systematic Approach includes: History taking – Establishing the Current Status of the Lens and its Relationship with the Eye and Adnexa plus Px requirements, needs and expectations Elimination of confounding issues – Identifying & Treating Non-Contact Lens Related, Co-existing, Systemic and Ocular Diseases – Treating Evident Contact Lens Related Problems Treatment of the Symptomatic CL Patient with a Clinically Acceptable Lens

3. Levels of Evidence – Clinical Studies Level I – Evidence obtained from at least one properly conducted, well- designed randomized controlled trial or evidence from studies applying rigorous statistical approaches Level II – Evidence obtained from one of the following: Well-designed controlled trial without randomization Well-designed cohort or case-control analytic study from one (preferably more) center(s) Well-designed study accessible to more rigorous statistical analysis. Level III – Evidence obtained from one of the following: Descriptive studies Case reports Reports of expert committees Expert opinion Meeting abstracts, unpublished proceedings

4. Adjusting Replacement Frequency – Few relevant studies – No Level I evidence for efficacy of increased replacement frequency – Level II evidence supports use of Daily Disposables Silicone Hydrogel Mechanism may be via elimination of care system – RGPs More frequent replacement is ineffective 3 months vs non replaced

5. Changing Material – Hydrogel to Silicone Hydrogel No firm consensus – Studies on both sides (pro and con) Methodological problems in many cases undermine value Balance of evidence mildly favourable – Need for more well designed studies

6. Wetting Agents – Internal (Manufacturer Incorporated) HA, PVA No clear effect demonstrated (level II) – External (Packaging solution additive or pre- conditioning treatment) CMC, HPMC, Guar Pre-conditioning may increase comfortable wearing time (level II & III) Incorporation into lens packing solution generally gives short term benefits evident early in the wearing cycle (level II & III)

7. Lens Factors (Soft Lenses) – Edge shape (Level I-) Thin, knife edge > chisel > round – Base curve (Level I-,II,III) Steeper better (down to 8.3 mm) – Diameter (Level I-) Larger better (up to 13.5mm) – Back Surface Shape – Design (Level I-) No systematic pattern – Monocurve least preferred – Centre thickness (Level II-) Ineffective – Practical Issues Manipulation of individual parameters difficult due to design component interdependence and unless lenses are custom made, control may lie with manufacturer

8. Lens Factors (Rigid Lenses) – Favourable Larger diameters – 10mm (Level II) Rounded anterior edge shape (Level II) Respecting the corneal contour – Toric back surfaces for astigmatism (Level III) – Unfavourable Excessively steep fitting – Optimal and slightly flat preferred (Level II) Very thin lenses – Flexure (Level I)

9. Changing the Care System – Clinical study evidence conflicting as to benefits of change with a given material (Level I) – Comfort benefits can accrue from optimising the combination of lens type and solution type (Level II) Optimum combination may involve products from different manufacturers – Evidence for any effect with RGPs is scant

10. Tear Supplementation – Eye Drops, Wetting Agents Widely regarded as mainstay of treatment – Clinical benefit generally evident in trials 0.9% saline (Level II) CMC, PVA (Level III) 2% povidone (Level III) Recent studies tend to favour more complex solutions over saline alone – Hydroxypropyl Cellulose Ophthalmic Inserts Effective in reducing dryness symptoms after 1 m (Level II & III)

11. Nutrition – Essential Fatty Acid (EFA) Supplementation Beneficial in dry eye BUT….. Little evidence in CL wearers – No studies of omega-3 – Omega-6 (evening primrose oil) beneficial (Level I - female sample) – Hydration No studies

12. Punctal Occlusion – Balance of evidence suggests increased tear volume is beneficial Silicone plug superior to dissolvable collagen Upper and lower occlusion better than lower lid alone – Other factors need consideration Relative invasiveness Specialist skills needed

13. Topical medication – Azythromycin Only one relevant study – 1% b.i.d. beneficial over 1 month (Level II) – Cyclosporin No clear evidence of benefit – Two studies with contradictory results (Level I & II) – Steriods No studies – Use not justified in view of potential risks – NSAIDs Soft CLs – No studies RGPs – 0.1% diclofenac q.i.d may reduce post fitting adaptation (Level III) – Anaeshtetics Long term use insupportable

14. Environment – Few studies Low humidity gives poorer RGP comfort (Level III) SCLs avoid dust, pollen, smoke, low humidity (Level III) Blinking Behaviour – Can modify number of complete blinks No evidence for effect on CL comfort

15. Alternative Approaches – RGP to SCL Generally beneficial (Level II) – Vision worse – SCL to RGP No studies – Orthokeratology, Refractive Surgery No studies Future – Neuromodulation

16. No Yes No Summary of management strategies for contact lens related discomfort – Determine most likely cause – Identify corresponding treatment strategy – Stepwise (additive) application of treatments to achieve maximum effect

17. Thank you QUESTIONS?