Conditions: Acute Otitis Media
Keywords: AOMT tympanostomy tubes Otorrhea anti-infective
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 84
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate a single application of AL-60371/AL-817 Otic Suspension relative to ototopical CIPRODEX for sustained clinical cure, microbiological success, and time to cessation of otorrhea.

Detailed description:
The results at the time of the interim analysis met the futility criteria and the study was subsequently stopped.

Arms:
arm 1: AL-60371/AL-817 otic suspension, 200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1) arm 2: Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension, 4 drops in affected ear(s) twice daily through tympanostomy tube for 7 days

Interventions: intervention 1: AL-60371/AL-817 otic suspension intervention 2: Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension
Intervention descriptions: intervention 1: None intervention 2: CIPRODEX®

Protocol document: