Efficacy and Safety of Ciprofloxacin and Fluocinolone Solution in the Treatment of Acute Otitis Media with Tympanostomy Tubes Otorrhea in Children: A Comparative Clinical Trial

Purpose: Evaluate the efficacy and safety of topical ciprofloxacin 0.3% plus fluocinolone acetonide 0.025% otic solution (CIPRO+FLUO) relative to ciprofloxacin 0.3% (CIPRO) alone, and to fluocinolone acetonide 0.025% alone in children with Acute Otitis Media with Tympanostomy Tubes Otorrhea (AOMT). Methods: This trial was conducted at multiple sites and was approved by the FDA and respective IRBs. 662 patients between 6 months and 12 years old with AOMT in at least one ear were enrolled. All patients were randomized and assigned to one of the 3 cohorts in a 1:1:1 …