Abstract
PURPOSE: To compare the efficacy and safety of 0.1% dexamethasone/0.3% netilmicin (Netildex), with that of 0.1% dexamethasone/0.3% tobramycin (Tobradex) in the treatment of external ocular inflammation requiring antibiotic therapy. METHODS: In this randomized, double-blind study, 139 subjects with conjunctival inflammation associated with signs of ocular infection were treated with Netildex (n = 71) or Tobradex (n = 68) four times daily for 6 days. The primary efficacy analysis was based on the percentage of patients with at least a 50% decrease in conjunctival hyperemia at the endpoint visit (Day 6 [± 1]) with respect to baseline (responder rate). An equivalence margin of 20% was set for this study. A follow-up visit was performed at Day 14 (± 1). Other efficacy parameters were: conjunctival edema, conjunctival discharge, lid hyperemia, lid edema, presence of ocular infection, and symptoms of ocular discomfort. Safety evaluations included intraocular pressure, visual acuity, and adverse events. RESULTS: At Day 6, a decrease of conjunctival hyperemia was observed in 87.3% and 90.9% of the patients treated with Netildex and Tobradex, respectively. The 95% confidence interval for the difference between groups (-15.3 ÷ 8.0) satisfied the equivalence hypothesis. Subjects treated with Netildex had a better control of lid hyperemia (P = 0.016), tearing (P = 0.001), burning (P = 0.007), and stinging (P = 0.004). No adverse reactions were observed during the study except one case of keratitis in the Tobradex group. CONCLUSION: Netildex was as effective and safe as Tobradex in reducing signs and symptoms in patients with conjunctival inflammation when ocular infection was suspected.