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 < or =25 years and >50 years was significantly associated with the development of corneal infiltrates (< or =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 > or =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.