Wearer Retention and Disposition in the Post Approval Evaluation of Lotrafilcon a in the US

Abstract

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