OTO-201 for Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement

A Prospective, Randomized, Double-Blind, Placebo- and Sham-Controlled, Multicenter, Phase 1b Study of OTO-201 Given as a Single Intratympanic Injection for Intra-Operative Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01755286

Enrollment

Registered

2012-12-24

Start date

2012-12-31

Completion date

2013-06-30

Last updated

2013-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement

Brief summary

The purpose of this study is to describe the safety and tolerability of two dose levels of OTO-201, placebo and sham when administered intra-operatively in pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.

Interventions

DRUGOTO-201

Single intra-operative injection

DRUGPlacebo

Single intratympanic injection

DRUGSham

Simulated single intratympanic injection

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Months to 12 Years

Healthy volunteers

Inclusion criteria

includes, but is not limited to: * Subject is a male or female aged 6 months to 12 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 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 tympanostomy tube placement * Subject has a history of sensorineural hearing loss * Subject has a history of chronic or recurrent bacterial infections other than otitis media that likely will require treatment with antibiotics during the course of the study

Design outcomes

Primary

Measure	Time frame	Description
Safety	Up to 1 month	Evaluation of adverse events, otoscopic exams, audiometry, and tympanometry

Secondary

Measure	Time frame	Description
Clinical Activity	Up to 1 month	Evaluation of physician reported and caregiver reported otorrhea
Microbiological Eradication	Up to 1 month	Microbiological eradication of pretherapy bacteria

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026