Comparison of two otologic suspensions of ciprofloxacin 2 mg/mL and hydrocortisone 10 mg/mL in the treatment of otitis externa: a multicenter, double-blind, randomized study / Comparação de duas suspensões otológicas de ciprofloxacino 2 mg/mL e hidrocortisona 10 mg/mL no tratamento da otite externa: um estudo multicêntrico, duplo-cego e randomizado

ABSTRACT

This was Phase III multicenter, double-blind, randomized, comparative safety and efficacy study in parallel groups of subjects, assessing non-inferiority between two commercially available otologic suspensions containing ciprofloxacin 2mg/mL and hydrocortisone 10mg/mL (Otociriax and Cipro HC®) in the treatment of acute diffuse otitis externa. Following screening and informed consent, subjects were randomly allocated into two treatment groups Group A (treated with Otociriax) and Group B (treated with Cipro HC®). Treatment regimen in both groups was three drops, twice daily for seven days. The primary study endpoint was otitis cure, defined as elimination of pain, edema, and otorrhea. The secondary study endpoint was presence of side effects. Efficacy assessments included presence and intensity of otitis externa manifestations. Safety assessments included vital signs and physical examination, as well as adverse event monitoring. Study data analysis was performed using GraphPad Prism 5.0...