Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes

Otonomy

Status and phase

Completed

Phase 3

Conditions

Otitis Media

Treatments

Drug: OTO-201 (ciprofloxacin)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02600559

201-201507

Details and patient eligibility

About

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.

Enrollment

501 patients

Sex

All

Ages

6 months to 17 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria includes, but is not limited to:

Subject is a male or female aged 6 months to 17 years, inclusive
Subject has a history of otitis media requiring bilateral tympanostomy tube placement
Subject's caregiver is willing to comply with the protocol and attend all study visits

Exclusion Criteria includes, but is not limited to:

Subject has a history of prior ear or mastoid surgery, not including myringotomy or myringotomy with TT placement
Subject has been designated for any other surgical procedure that would occur concurrently with TT placement, except adenoidectomy, airway endoscopy, nasal endoscopy, and nasal cautery for epistaxis
Subject has a history of sensorineural hearing loss