PURPOSE: To examine the rate and types of ocular adverse events among children wearing soft contact lenses. METHODS: This study is a retrospective review of ocular adverse event data from six randomized controlled trials among a total of 581 myopic children (aged 7-15 years at baseline) administered daily disposable hydrogel contact lenses (etafilcon A). RESULTS: During 816 patient years of contact lens wear, no significant or serious ocular adverse events were reported. A total of 86 non-significant ocular adverse events occurred in 53 children. The crude rate of ocular adverse events was 10.6 per 100 patient years with the estimated pooled incidence being 8.9 per 100 patient years (95% CI: 4.5-17.4). Two asymptomatic corneal infiltrative events were reported (both non-significant), which is an incidence of 0.3 (95% CI: 0.1-0.9) per 100 patient years. The most common ocular adverse events (n) were slit-lamp findings of Grade 2 or less requiring treatment (26), unspecified conjunctivitis (14), and allergic conjunctivitis (13). No cases of microbial keratitis were observed. Of the 86 adverse events, 37 were classified as highly likely or possibly lens-related, giving a crude incidence of 4.5 per 100 patient years for contact lens-related events. The crude incidence of ocular adverse events among spectacle wearers was 1.8 per 100 patient years. CONCLUSION: These data suggest that daily disposable soft contact lenses can be safely worn by children. Additional studies will be needed to precisely quantify the adverse event rate of soft contact lenses in normal clinical practice.
PURPOSE: To examine the rate and types of ocular adverse events among children wearing soft contact lenses. METHODS: This study is a retrospective review of ocular adverse event data from six randomized controlled trials among a total of 581 myopic children (aged 7-15 years at baseline) administered daily disposable hydrogel contact lenses (etafilcon A). RESULTS: During 816 patient years of contact lens wear, no significant or serious ocular adverse events were reported. A total of 86 non-significant ocular adverse events occurred in 53 children. The crude rate of ocular adverse events was 10.6 per 100 patient years with the estimated pooled incidence being 8.9 per 100 patient years (95% CI: 4.5-17.4). Two asymptomatic corneal infiltrative events were reported (both non-significant), which is an incidence of 0.3 (95% CI: 0.1-0.9) per 100 patient years. The most common ocular adverse events (n) were slit-lamp findings of Grade 2 or less requiring treatment (26), unspecifiedconjunctivitis (14), and allergic conjunctivitis (13). No cases of microbial keratitis were observed. Of the 86 adverse events, 37 were classified as highly likely or possibly lens-related, giving a crude incidence of 4.5 per 100 patient years for contact lens-related events. The crude incidence of ocular adverse events among spectacle wearers was 1.8 per 100 patient years. CONCLUSION: These data suggest that daily disposable soft contact lenses can be safely worn by children. Additional studies will be needed to precisely quantify the adverse event rate of soft contact lenses in normal clinical practice.