title: Rates of adverse events with hydrogel and silicone hydrogel daily disposable lenses in a large postmarket surveillance registry: the TEMPO Registry.
abstract: OBJECTIVE
  To report annualized adverse events (AEs) including corneal infiltrative events (CIEs) with use of silicone hydrogel (SiHyDD) and hydrogel daily disposable (HydDD) soft contact lenses (SCLs) in the 1•DAY ACUVUE TruEye or 1•DAY ACUVUE MOIST Performance Overview (TEMPO) Registry (NCT01467557).
  
  
  METHODS
  Annualized incidence of symptomatic daily disposable (DD)-related AEs was calculated from 3064 surveys from 1171 subjects (601 SiHyDD and 570 HydDD, 31.8 ± 13.5 years, 68% female) during 1 year. Three independent experts adjudicated potential AE cases. Demographics were compared between wearers with and without AEs.
  
  
  RESULTS
  The registry tracked 960.3 years of lens wear: SiHyDD 489.4 years and HydDD 470.9 years. In that period, the 601 SiHyDD wearers reported eight AEs with office visits (1.6%/y; 2 CIEs, 0.4%/y), eight (1.6%/y) without office visits, and four AEs unrelated to SCLs (0.8%/y) (SiHyDD wearers with AEs; 44.8 ± 12.5 years; 75% female). The 570 HyDD wearers reported three AEs with office visits (0.6%/y; no CIEs), five without office visits (1.1%/y), and one non-SCL-related AE (0.2%/y) (HydDD wearers with AEs; 26.3 ± 8.0 years; 100% female). These CIE rates are significantly lower than the lowest estimate of 3.3% from prior studies. Wearers with SiHyDD-related AEs were significantly older than unaffected wearers (P = 0.02), but not for HydDD-related AEs.
  
  
  CONCLUSIONS
  The CIE rates of 0.4% and 0% with these DD lenses are significantly lower than rates reported with reusable SCLs (3%-4%/y), indicating improved safety outcomes with these DD lenses. Compared to unaffected wearers, SiHyDD lens wearers with AEs requiring clinical visits were significantly older. (ClinicalTrials.gov number, NCT01467557.).
authors.affiliation: Clinical Trial Consultant, Atlanta, Georgia, United States.
authors.forename: Robin L
authors.initials: RL
authors.lastname: Chalmers
authors.affiliation: Director, Medical Affairs, Johnson & Johnson Vision Care, Inc., Jacksonville, Florida, United States.
authors.forename: Sheila B
authors.initials: SB
authors.lastname: Hickson-Curran
authors.affiliation: The George Institute for Global Health, University of Sydney, Sydney, Australia.
authors.forename: Lisa
authors.initials: L
authors.lastname: Keay
authors.affiliation: Foresight Regulatory Strategies, Inc., Wilmington, Massachusetts, United States.
authors.forename: William J
authors.initials: WJ
authors.lastname: Gleason
authors.affiliation: Foresight Regulatory Strategies, Inc., Wilmington, Massachusetts, United States.
authors.forename: Roger
authors.initials: R
authors.lastname: Albright
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D003263:Contact Lenses, Hydrophilic / Q000009:adverse effects*; D004209:Disposable Equipment; D005260:Female; D006801:Humans; D020136:Hydrogel, Polyethylene Glycol Dimethacrylate; D015994:Incidence; D007634:Keratitis / Q000453:epidemiology* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data*; D012042:Registries; D012307:Risk Factors; D012828:Silicones; D014481:United States / Q000453:epidemiology; D055815:Young Adult
chemical_list: D012828:Silicones; D020136:Hydrogel, Polyethylene Glycol Dimethacrylate
keywords: adverse events; corneal infiltrates; daily disposable contact lenses; postmarket surveillance; registry