May 2005
Volume 46, Issue 13
ARVO Annual Meeting Abstract  |   May 2005
Wearer Retention and Disposition in the Post Approval Evaluation of Lotrafilcon a in the US
Author Affiliations & Notes
  • R.L. Chalmers
    Clinical Trial Consultant, Atlanta, GA
  • J.J. McNally
    CIBA Vision Corp., Duluth, GA
  • O. Schein
    Johns Hopkins Medical Institute, Baltimore, MD
  • J. Tielsch
    Johns Hopkins Bloomberg School of Public Health, Baltimore, MD
  • J. Katz
    Johns Hopkins Bloomberg School of Public Health, Baltimore, MD
  • E. Alfonso
    Bascom Palmer Eye Institute, Miami, FL
  • M.A. Bullimore
    The Ohio State University College of Optometry, Columbus, OH
  • D. O'Day
    Vanderbilt Eye Institute, Nashville, TN
  • J. Shovlin
    Northeastern Eye Institute, Scranton, PA
  • Footnotes
    Commercial Relationships  R.L. Chalmers, CIBA Vision C; Alcon C; Rose Biomedical C; Hydrogel Vision C; J.J. McNally, CIBA Vision E; O. Schein, CIBA Vision C; J. Tielsch, CIBA Vision C; J. Katz, CIBA Vision F, C; E. Alfonso, CIBA Vision C; M.A. Bullimore, Eyeonics C; Refractec C; Alcon C; CIBA Vision C; Paragon Vision Sciences C; Staar Surgical C; D. O'Day, CIBA Vision C; J. Shovlin, CIBA Vision C.
  • Footnotes
    Support  CIBA Vision, a Novartis Company
Investigative Ophthalmology & Visual Science May 2005, Vol.46, 2068. doi:
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      R.L. Chalmers, J.J. McNally, O. Schein, J. Tielsch, J. Katz, E. Alfonso, M.A. Bullimore, D. O'Day, J. Shovlin; Wearer Retention and Disposition in the Post Approval Evaluation of Lotrafilcon a in the US . Invest. Ophthalmol. Vis. Sci. 2005;46(13):2068.

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

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Abstract: : Purpose: To report the one year retention and disposition of wearers prescribed 30 night continuous wear who were registered in the post–market evaluation of lotrafilcon A lenses in the US. Methods: 6,245 wearers who intended to use a 30 night continuous wearing schedule of lotrafilcon A lenses registered for the study in 131 practices in the US and Canada. Practices were selected based on volume of lens sales and included private practices, corporate practices, and retail settings. After registration, wearers were contacted directly at 3 and 12 months and asked, among other questions, whether they had experienced an episode of painful, red eyes which caused them to seek eye care. Any events that presented to the registering practice were reported directly by the practice. All events were reviewed for the presence of a corneal infiltrate and forwarded to an Endpoint Adjudication Committee. Results: Of the enrolled cohort, 5,903 (94.5%) wearers completed final exit questionnaires and only 342 (5.5%) were lost to follow–up. 4,995 wearers (80.0%) completed the one year period wearing lenses and 908 (14.5%) discontinued wear of the study lenses. Of the reported events, 167 (2.7%) corneal infiltrates of varying severity have been confirmed in 158 wearers (2.5%). At the 12 month survey 79.3% of wearers reported overnight wear of lenses for >21 nights in a row; 9.3% wore them 1–2 weeks in a row; 7.6% for 1–6 nights and 3.2% for daily wear only. Conclusions: The design of this study has resulted in a very high follow–up rate. The infiltrate event rate in this post–approval evaluation was similar to that reported in the FDA pre–market approval study, indicating robust performance of the lenses when released for wider use outside of clinical trials.

Keywords: contact lens • clinical (human) or epidemiologic studies: biostatistics/epidemiology methodology 

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