ABSTRACT
OBJECTIVE: To determine the efficacy and safety of topical ciprofloxacin/dexamethasone otic suspension compared with ofloxacin otic solution in the treatment of acute otitis media with otorrhea through tympanostomy tubes (AOMT) in pediatric patients. METHODS: This multicenter, prospective, randomized, observer-masked, parallel-group study was conducted at 39 sites in 599 children aged >or=6 months to 12 years with an AOMT episode of Subject(s)
Anti-Infective Agents/therapeutic use
, Anti-Inflammatory Agents/therapeutic use
, Ciprofloxacin/therapeutic use
, Dexamethasone/therapeutic use
, Ofloxacin/therapeutic use
, Otitis Media with Effusion/drug therapy
, Acute Disease
, Administration, Topical
, Anti-Infective Agents/adverse effects
, Anti-Inflammatory Agents/adverse effects
, Child
, Child, Preschool
, Ciprofloxacin/adverse effects
, Dexamethasone/adverse effects
, Drug Therapy, Combination
, Female
, Humans
, Infant
, Male
, Middle Ear Ventilation
, Ofloxacin/adverse effects
, Otitis Media with Effusion/microbiology
, Prospective Studies
, Suspensions
