This analysis reports on risk factors for corneal infiltrative events from a 1-year, randomized clinical trial of lotrafilcon A lenses.
Six hundred fifty-eight subjects randomized to lotrafilcon A lenses were observed in a 1-year clinical trial in the United States. Risk factors gathered at baseline were analyzed to determine their association with corneal infiltrative events.
Factors examined but not found to be associated with events were male sex, history of extended or daily lens wear, refractive error, neovascularization, or assessment of lens fit. Significant factors included subject age 18 to 29 years, smoking, smoking and young age combined, history of corneal scar, contact lens acute red eye (CLARE), and corneal infiltrates.
Risk factors for corneal infiltrative events with silicone hydrogel lenses worn for 30 nights of continuous wear have been identified. Wearers with a history of inflammatory events such as contact lens peripheral ulcer or CLARE should consider 30-night continuous wear with these lenses. Careful counseling of wearers who smoke is advised.