title: Patient-Reported Wearing Experience From Hydrogel Daily Disposable Wearers Older Than 40 Years From the TEMPO Registry.
abstract: OBJECTIVE
  To describe the patient-reported wearing experience over time among wearers of hydrogel daily disposable (HydDD) contact lenses (CLs) in the TruEye and Moist Performance Overview (TEMPO) Registry (NCT01467557).
  
  
  METHODS
  Registered wearers older than 40 years who were recently fit with 1-DAY ACUVUE MOIST HydDDs completed self-administered questionnaires four times during a year-long Registry. Overall opinion of CLs, replacement schedules, Contact Lens Dry Eye Questionnaire (CLDEQ-8), and compliance were queried. Data were analyzed with analysis of variance and signed rank tests.
  
  
  RESULTS
  A total of 86 subjects (24% men, age 50.2±7.1 years) completed the Registry. Approximately 76% were new to daily disposable lenses, and 8% were neophytes. Overall opinion of CLs improved significantly after refitting with HydDDs (baseline 57% excellent/very good vs. 69%-79% at follow-ups, P<0.05 all vs. baseline). Changing to HydDDs maintained average and comfortable wear time (P>0.05), and it did significantly improve CLDEQ-8 scores at all follow-ups (baseline, 11.2±7.3 vs. 2 weeks, 7.8±5.8, P<0.0001; 4 months, 8.6±6.5, P=0.0006; 12 months, 9.3±6.5, P=0.01). Self-assessment of compliance was excellent/very good for 80% at baseline, and improved to 92% to 98% at follow-ups (P<0.0001). More than 90% never slept in their HydDDs, although compliance to daily replacement diminished from 2-week to 4-month surveys (93% vs. 84%, P=0.007).
  
  
  CONCLUSIONS
  After refitting with HydDDs, older wearers reported significantly higher overall opinions of their lenses, better CLDEQ-8 symptom scores, and most were compliant with proper daily disposable lens use. Diminishing daily replacement rates from 2 weeks to 4 months indicate a need to reinforce that recommendation. Wearers of HydDD CLs older than 40 years experienced many benefits from refitting with these daily disposable lenses.
authors.affiliation: Medical Affairs, Johnson & Johnson Vision Care, Inc. (S.B.H-C.), Jacksonville, FL; Clinical Trial Consultant (R.L.C.), Atlanta, GA; The George Institute for Global Health (L.K.), Sydney, NSW, Australia; and Foresight Regulatory Strategies, Inc. (W.G.), Wilmington, MA.
authors.forename: Sheila B
authors.initials: SB
authors.lastname: Hickson-Curran
authors.forename: Robin L
authors.initials: RL
authors.lastname: Chalmers
authors.forename: Lisa
authors.initials: L
authors.lastname: Keay
authors.forename: William
authors.initials: W
authors.lastname: Gleason
mesh_terms: D003263:Contact Lenses, Hydrophilic / Q000706:statistics & numerical data*; D004209:Disposable Equipment; D005260:Female; D006801:Humans; D020136:Hydrogel, Polyethylene Glycol Dimethacrylate; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D011358:Product Surveillance, Postmarketing; D012042:Registries; D011795:Surveys and Questionnaires
chemical_list: D020136:Hydrogel, Polyethylene Glycol Dimethacrylate