Completed

NCT Number: NCT02350998

Open-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration

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.

Completed

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Key information

Conditions

Bilateral Middle Ear Effusion

Age range

6 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Central California Ear, Nose and Throat, Fresno, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OTO-201

Drug

Primary outcomes

Otoscopic Examination: Auricle and Meatus

Time frame: Up to 1 month

Number of ears whose external ear and ear canal (auricle and meatus), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29
Otoscopic Examination: Tympanic Membrane

Time frame: up to 1 month

Number of ears whose ear drum (tympanic membrane), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29
Otoscopic Examination: Tube Patency

Time frame: Up to 1 month

Subjects with at least one ear tube patent (i.e., not blocked) at Day 29

Secondary outcomes

Feasibility of Administration

Time frame: Day 1

Ease of administering OTO-201 through the tympanostomy tube: Number of subjects that investigators rated ease of administration as either "easy" or "very easy"

Sponsors and collaborators

Lead sponsor

Otonomy, Inc.

Industry

Registry information

Official study title

A 1-Month, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Trans-Tympanic Tube Administration for Intra-Operative Treatment of Middle Ear Effusion in Pediatric Subjects With Otitis Media Requiring Tympanostomy Tube Placement

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Jan 30, 2015
Registry last updated: Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.