Brief Title
OTO-413 in Subjects With Speech-in-Noise Hearing Impairment
Official Title
A Randomized, Double-blind, Placebo-controlled Phase 1/2 Study of OTO-413 Given as a Single Intratympanic Injection in Subjects With Speech-in-noise Hearing Impairment
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and exploratory efficacy
of OTO-413 administered as an intratympanic injection for the treatment of speech-in-noise
hearing impairment.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Treatment Emergent Adverse Events (Safety)
Condition
Sensorineural Hearing Loss
Intervention
OTO-413
Study Arms / Comparison Groups
OTO-413
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
70
Start Date
October 1, 2019
Completion Date
June 2022
Primary Completion Date
June 2022
Eligibility Criteria
Inclusion Criteria:
- Subject has audiometrically-defined normal hearing or up to moderately severe hearing
impairment.
- Subject has self-reported difficulty hearing in noisy environments for at least 6
months prior to Screening.
- Subject exhibited a speech-in-noise hearing deficit in at least one ear.
Exclusion Criteria:
- Subject is pregnant or lactating.
- Subject has the following hearing disorders or any other hearing disorders that may
impact the efficacy assessments or safety of the subject in the opinion of the
Investigator: Meniere's disease, congenital hearing loss, or genetic sensorineural
hearing loss.
- Subject has a cochlear implant or consistently uses a hearing aid.
- Subject has worked at least 5 years as a professional musician or has had at least 15
years of formal musical training.
- Subject self-reports bothersome, subjective tinnitus and is consistently aware of
their tinnitus throughout much of the waking day.
Gender
All
Ages
21 Years - 64 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04129775
Organization ID
413-201901
Responsible Party
Sponsor
Study Sponsor
Otonomy, Inc.
Study Sponsor
, ,
Verification Date
June 2022