PMID- 25574042
OWN - NLM
STAT- MEDLINE
DCOM- 20150406
LR  - 20171116
IS  - 1552-5783 (Electronic)
IS  - 0146-0404 (Linking)
VI  - 56
IP  - 1
DP  - 2015 Jan 8
TI  - Rates of adverse events with hydrogel and silicone hydrogel daily disposable 
      lenses in a large postmarket surveillance registry: the TEMPO Registry.
PG  - 654-63
LID - 10.1167/iovs.14-15582 [doi]
AB  - PURPOSE: 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.).
CI  - Copyright 2015 The Association for Research in Vision and Ophthalmology, Inc.
FAU - Chalmers, Robin L
AU  - Chalmers RL
AD  - Clinical Trial Consultant, Atlanta, Georgia, United States.
FAU - Hickson-Curran, Sheila B
AU  - Hickson-Curran SB
AD  - Director, Medical Affairs, Johnson & Johnson Vision Care, Inc., Jacksonville, 
      Florida, United States.
FAU - Keay, Lisa
AU  - Keay L
AD  - The George Institute for Global Health, University of Sydney, Sydney, Australia.
FAU - Gleason, William J
AU  - Gleason WJ
AD  - Foresight Regulatory Strategies, Inc., Wilmington, Massachusetts, United States.
FAU - Albright, Roger
AU  - Albright R
AD  - Foresight Regulatory Strategies, Inc., Wilmington, Massachusetts, United States.
LA  - eng
SI  - ClinicalTrials.gov/NCT01467557
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20150108
PL  - United States
TA  - Invest Ophthalmol Vis Sci
JT  - Investigative ophthalmology & visual science
JID - 7703701
RN  - 0 (Silicones)
RN  - 25852-47-5 (Hydrogel, Polyethylene Glycol Dimethacrylate)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Child
MH  - Contact Lenses, Hydrophilic/*adverse effects
MH  - Disposable Equipment
MH  - Female
MH  - Humans
MH  - *Hydrogel, Polyethylene Glycol Dimethacrylate
MH  - Incidence
MH  - Keratitis/*epidemiology/etiology
MH  - Male
MH  - Middle Aged
MH  - Product Surveillance, Postmarketing/*statistics & numerical data
MH  - *Registries
MH  - Risk Factors
MH  - *Silicones
MH  - United States/epidemiology
MH  - Young Adult
OTO - NOTNLM
OT  - adverse events
OT  - corneal infiltrates
OT  - daily disposable contact lenses
OT  - postmarket surveillance
OT  - registry
EDAT- 2015/01/13 06:00
MHDA- 2015/04/07 06:00
CRDT- 2015/01/10 06:00
PHST- 2015/01/10 06:00 [entrez]
PHST- 2015/01/13 06:00 [pubmed]
PHST- 2015/04/07 06:00 [medline]
AID - iovs.14-15582 [pii]
AID - 10.1167/iovs.14-15582 [doi]
PST - epublish
SO  - Invest Ophthalmol Vis Sci. 2015 Jan 8;56(1):654-63. doi: 10.1167/iovs.14-15582.