Purpose. To describe the factors associated with symptomatic corneal infiltrates in a postmarket surveillance study of continuous wear contact lenses.
Methods. Patients intending to wear lotrafilcon A lenses continuously for 30 days and nights were registered in a 1-year study at 131 clinical sites. A self-administered questionnaire was used to gather demographic and other data at baseline. The severity of the incidence of corneal infiltrative events during the year-long study was graded by an independent adjudication committee.
Results. Of 6245 lens wearers, 163 were reported to have symptomatic corneal infiltrative events (2.6%). In 159 wearers, the infiltrates were judged to be lens-related (2.5%). Age ≤25 years and >50 years was significantly associated with the development of corneal infiltrates (≤25 years OR = 1.75, 95% CI = 1.24–2.48 and >50 years OR = 2.04, 95% CI = 1.40–2.98). Ametropia of ≥5.00 D was significantly associated with corneal infiltrates (OR = 1.60, 95% CI = 1.08–2.37). Study participants who typically wore lenses for >21 consecutive days and nights were significantly less likely to have infiltrates than those who wore lenses for fewer consecutive days and nights (OR = 0.43, 95% CI = 0.24–0.75). Smoking concurrent with contact lens wear was weakly associated with corneal infiltrates (OR = 1.47, CI = 0.99–2.18).
Conclusions. Patient age, degree of refractive error, and failure to achieve the intended wearing schedule were associated with development of symptomatic corneal infiltrative events.
Clinical Trial Consultant, Atlanta, Georgia (RLC), CIBA Vision Corporation, Duluth, Georgia (JJM), Johns Hopkins University School of Medicine, Department of Ophthalmology, Baltimore, Maryland (ODS), Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland (JK, JMT), Bascom Palmer Eye Institute, Miami, Florida (EA), The Ohio State University College of Optometry, Columbus, Ohio (MAB), Department of Ophthalmology, Vanderbilt University School of Medicine, Nashville, Tennessee (DO), and Northeastern Eye Institute, Scranton, Pennsylvania (JS)
Received October 24, 2006; accepted March 22, 2007.