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Predictors for misuse of daily disposable lenses in a large post-market surveillance registry – The TEMPO Registry

February 3rd, 2016
photo_bio_robinRobin Chalmers is a clinical trials consultant based in the United States.

Download the poster (.pdf), which was originally shared at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting, 2015.


Robin L. Chalmers1 , Sheila B. Hickson-Curran2 , Lisa J. Keay3 , William Gleason4
1 Clinical Trial Consultant, Atlanta, Georgia, United States;
2 Professional Development Department, Johnson & Johnson Vision Care, Jacksonville, Florida, United States;
3 Injury, George Institute for Global Health, Sydney, New South Wales, Australia;
4 none, Foresight Regulatory Strategies, Inc., Wilmington, Massachusetts, United States

Purpose: To describe predictors for overnight wear (EW) and storage and reuse (re-use) of daily disposable (DD) lenses among wearers of silicone hydrogel (SiHyDD) or hydrogel daily disposable (HydDD) lenses in the 1•DAY ACUVUE® TruEye® (narafilcon B) or 1•DAY ACUVUE® MOIST® (etafilcon A) Performance Overview (TEMPO) Registry (#NCT01467557).

Methods: At registration, 977 habitual SCL wearers rated their compliance with care of their SCLs and their eye care practitioners (ECPs) also rated their compliance with instructions. Wearers reported frequency of EW and reuse, key aspects of DD lens wear at 2 wks, 4 mos and 12 mos via online surveys. A Wilcoxon Signed Rank test compared the Likert scale rating of compliance between the ECP and wearer. Reports of EW or re-use were modelled using generalized estimating equations (GEE) with survey as a repeated measure, adjusting for clustering by ECP site. The model included age, gender, ECP and wearer rated compliance, and self-report of EW with habitual SCLs.

Results: The Registry observed 977 habitual SCL wearers (801 (82%) for 12 mos) and included 240 (24.6%) who reported EW with habitual lenses, usually for <1 day/week. There were no significant differences between ECP and wearer ratings of overall compliance with habitual SCLs (p=0.36, Wilcoxon Signed Rank test). EW with DDs increased from 14% at 2 wks to 22% at 12 mos surveys (Odds Ratio (OR) 1.52 (1.24, 1.87 95% CI) and re-use of DDs increased from 9% at 2 wks to 17% at 12 mos surveys (OR 1.56 (1.32, 1.84). Baseline ratings of overall compliance predicted later re-use of DDs: ECP ratings (OR 1.56 (1.0, 2.4) p=0.05) and self-assessment (OR 1.72 (1.1, 2.6) p=0.01). EW of DDs was not predicted by baseline ECP or wearer compliance ratings but was strongly predicted by wearer report of EW with habitual SCLs at baseline (OR 9.7 (7.4, 12.7), p<0.0001).

Conclusions: During a year of remote follow-up in the TEMPO Registry, EW and reuse of DD lenses both increased significantly with longer time since refitting. Reuse of lenses was predicted by self- and ECP assessment of overall compliance at baseline and EW was strongly predicted by EW with habitual SCLs. Eye care practitioners must re-train as they fit DDs to lens wearers to proper use of DDs; no EW and no storage or re-use of lenses.

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    Predictors for misuse of daily disposable lenses in a large post-market surveillance registry – The TEMPO Registry

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