April 2014
Volume 55, Issue 13
Free
ARVO Annual Meeting Abstract  |   April 2014
Safety of Hydrogel and Silicone Hydrogel Daily Disposables in a Large Post-Market Surveillance Registry - The TEMPO Registry
Author Affiliations & Notes
  • Robin L Chalmers
    Clinical Trial Consultant, Atlanta, GA
  • Sheila B Hickson-Curran
    Clinical Trial Consultant, Atlanta, GA
  • Lisa J Keay
    Clinical Trial Consultant, Atlanta, GA
  • William Gleason
    Clinical Trial Consultant, Atlanta, GA
  • Footnotes
    Commercial Relationships Robin Chalmers, AcuFocus (C), Alcon Research, Ltd (C), CooperVision Corp. (C), Johnson & Johnson Vision Care (C); Sheila Hickson-Curran, Johnson & Johnson Vision Care (E); Lisa Keay, AcuFocus (C), Johnson & Johnson Vision Care (C); William Gleason, EyeTronix (C), Johnson & Johnson Vision Care (C), Menicon (C), Nova Bay Pharmaceuticals (C), Sauflon (C)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science April 2014, Vol.55, 862. doi:https://doi.org/
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      Robin L Chalmers, Sheila B Hickson-Curran, Lisa J Keay, William Gleason; Safety of Hydrogel and Silicone Hydrogel Daily Disposables in a Large Post-Market Surveillance Registry - The TEMPO Registry. Invest. Ophthalmol. Vis. Sci. 2014;55(13):862. doi: https://doi.org/.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: To describe safety outcomes among wearers of silicone hydrogel (SiHyDD) or hydrogel daily disposable (HydDD) lenses in the 1DAY ACUVUE® TruEye® or 1DAY ACUVUE® MOIST® Performance Overview (TEMPO) Registry (#NCT01467557).

Methods: Soft contact lens (SCL) related adverse events (AEs) were identified via self-report (“Yes” to “Have you had a red or painful eye while wearing your CLs since registering for this study that caused you to seek care at your eye doctor or emergency room?”) during 2,894 self-administered electronic questionnaires from 1171 subjects over 1 year from the TEMPO Registry. Years of wear were calculated by lens brand. AE diagnoses were adjudicated by 3 independent clinical experts. Prevalence of risk factors was % of subjects reporting the factor at any survey during the observation period.

Results: The Registry observed 960 years of wear; 489 years of SiHyDDand 471 years of HydDD wear. In that period, SiHyDD wearers reported 8 AEs that resulted in office visits (1.6%/year; 2 corneal infiltrative events (CIEs),0.4%/year), 8 reports without office visits (1.6%/year; e.g., foreign body, symptoms with no visits, allergic conjunctivitis), and 4 (0.8%/yr) with events that were not SCL related (allergic conjunctivitis, conjunctivitis, sub-conjunctival hemorrhage). For the HyDD wearers there were 3 AEs reported that resulted in office visits (0.6%/year; no corneal infiltrative events), 5 reports without office visits (1.1%/year; e.g., allergic conjunctivitis), and 1 AE (0.2%/yr) that was not SCL related (allergic conjunctivitis). Prevalence of risk factors to be reported at any of the 3 study surveys was: Any overnight wear 30%, Storage &Reuse of DD lenses 21%, >5.0D 22%, Age <25 years 31%, Age >50 years 10%, with no difference between lens brands.

Conclusions: Of 1,171 wearers of DDs in the TEMPO Registry with 960 years of wear, only 11, or approximately 1%, had SCL-related complications that prompted clinical visits and only 2 events were CIEs. The event rate with these DD lenses is considerably lower than rates previously reported with reusable SCLs and offers a strategy to improve the safety outcomes with SCL wear. 30% of this post-market sample of DD wearers reported some overnight wear on at least one survey during the year, thus re-training at the time of refitting with DDs is advised.

Keywords: 477 contact lens • 462 clinical (human) or epidemiologic studies: outcomes/complications  
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