Clinical Framework for Contact Lens Discomfort: Evidence-Based Management Strategies

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following: • Descriptive studies • Case reports • Reports of expert committees • Expert opinion • Meeting abstracts, unpublished proceedings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 • Monocurveleast 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% diclofenacq.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 Yes Yes No No Yes No Yes Yes No

17. Thank you QUESTIONS?