Conditions: Acute Otitis Externa Swimmer's Ear
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 262
Healthy volunteers: no

Brief summary:
This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study in which eligible subjects with acute otitis externa (AOE) will be randomized to receive a single administration of either 12 mg OTO-201 or Sham-Control (empty syringe) to the external auditory canal of the affected ear(s).

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: 12 mg ciprofloxacin intervention 2: Sham Control
Intervention descriptions: intervention 1: Single administration of OTO-201 intervention 2: Simulated, single adminstration

Protocol document: