Expired Study
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Winston-Salem, North Carolina


Purpose:

This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with bilateral middle ear effusion requiring tympanostomy tube placement. Eligible subjects will receive a single dose to each ear of 6 mg OTO-201, administered intraoperatively into the middle ear through the lumen of the tympanostomy tube (trans-tympanostomy tube TTT). The study is designed to characterize safety and any procedural issues associated with TTT drug administration of OTO-201.


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 clinical diagnosis of bilateral middle ear effusion requiring tympanostomy tube placement - Subject's caregiver is willing to comply with the protocol an 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 tympanostomy tube placement - Subject has a history of sensorineural hearing loss - Subject has been designated for any other surgical procedure that would occur concurrently with TT placement, such as, but not limited to adenoidectomy or tonsillectomy


NCT ID:

NCT02350998


Primary Contact:

Study Chair
Carl LeBel, PhD
Otonomy, Inc.


Backup Contact:

N/A


Location Contact:

Winston-Salem, North Carolina
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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