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

Phase 3

Completed

• Conditions: Bilateral Middle Ear Effusion
• Interventions: Drug: OTO-201

• Registration Number: NCT02350998
• Lead Sponsor: Otonomy, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-21
• Study First Submitted QC: 2015-01-29
• Study First Posted: 2015-01-30
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2020-09
• Results First Submitted: 2020-09-01
• Results First Submitted QC: 2020-09-01
• Results First Posted: 2020-09-23
• Last Update Submitted: 2020-09-24
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OTO-201	OTO-201	6 mg OTO-201 administered trans-tympanostomy tube

Primary Outcome Measures

Name	Time	Method
Otoscopic Examination: Auricle and Meatus	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	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	Up to 1 month	Subjects with at least one ear tube patent (i.e., not blocked) at Day 29

Secondary Outcome Measures

Name	Time	Method
Feasibility of Administration	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"

Trial Locations

Locations (4)

Charlotte Eye, Ear, Nose and Throat Associates; 🇺🇸 Matthews, North Carolina, United States

Central California Ear, Nose and Throat; 🇺🇸 Fresno, California, United States

Piedmont Ear, Nose and Throat; 🇺🇸 Winston-Salem, North Carolina, United States

Carolina Ear, Nose and Throat; 🇺🇸 Orangeburg, South Carolina, United States