Conditions: Acute Otitis Media AOMT
Keywords: Acute otitis media with tympanostomy tubes OTIPRIO
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 95
Healthy volunteers: no

Brief summary:
Dose Ranging Study of OTO-201 in AOMT

Detailed description:
This is a 1-month, prospective, multicenter, randomized, dose-ranging, sham-controlled, blinded study in which eligible subjects with either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT) will receive a single administration of 6 mg OTO-201, 12 mg OTO-201, or sham into the affected ear(s).

Arms:
arm 1: 6 mg OTO-201 (sustained-release suspension of ciprofloxacin), single 0.1 mL supra-tympanostomy tube (STT) administration to the affected ear(s) arm 2: 12 mg OTO-201 (sustained-release suspension of ciprofloxacin), single 0.2 mL supra-tympanostomy tube (STT) administration to the affected ear(s) arm 3: Sham (empty syringe), single 0.1 mL STT administration to the affected ear(s)

Interventions: intervention 1: 6 mg ciprofloxacin intervention 2: 12 mg ciprofloxacin intervention 3: Sham
Intervention descriptions: intervention 1: Single administration of OTO-201 intervention 2: Single administration of OTO-201 intervention 3: None

Protocol document: