OTO-413 in Subjects With Speech-in-Noise Hearing Impairment

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 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

, , [email protected]

Location Countries

United States

Location Countries

United States

NCT ID

NCT04129775

Organization ID

413-201901

Responsible Party

Sponsor

Study Sponsor

Otonomy, Inc.

Study Sponsor

, , 

Verification Date

July 2021