Conditions: Otitis Media
Keywords: Otitis media Ear infection Tympanostomy tubes
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 501
Healthy volunteers: no

Brief summary:
This is an 8-week, multicenter, open-label study in which eligible subjects with a history of otitis media requiring TT placement will receive 6 mg OTO-201 to each ear. The study is designed to evaluate the safety and efficacy of OTO-201 in subjects undergoing TT placement with common concurrent surgeries and any middle ear effusion status.

Detailed description:

Arms:
arm 1: Ciprofloxacin

Interventions: intervention 1: OTO-201 (ciprofloxacin)
Intervention descriptions: intervention 1: None

Protocol document: