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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

501 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Otitis Media

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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0.1 mL OTO-201

Ciprofloxacin

Group Type EXPERIMENTAL

OTO-201 (ciprofloxacin)

Intervention Type DRUG

Interventions

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OTO-201 (ciprofloxacin)

Intervention Type DRUG

Other Intervention Names

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OTIPRIO

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Minimum Eligible Age

6 Months

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No