OTO-413 in Subjects With Speech-in-Noise Hearing Impairment
- Registration Number
- NCT04129775
- Lead Sponsor
- Otonomy, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - OTO-413 OTO-413 -
- Primary Outcome Measures
Name Time Method Otoscopic Examinations (Safety) After dosing (Day 1) up to end of study (Day 85 - 12 weeks after dosing) Clinically significant change form Baseline
Treatment Emergent Adverse Events (Safety) Reported or observed during or after dosing (Day 1) up to the end of study (Day 85 - 12 weeks after dosing) An adverse event (AE) is any unfavorable and unintended diagnosis, symptom, sign, syndrome or disease which occurs during the study, having been absent at baseline, or if present at baseline, appears to worsen.
Audiometry (Safety) After dosing (Day 1) up to end of study (Day 85 - 12 weeks after dosing) Clinically significant change from Baseline
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
South Florida ENT Associates or Research Centers of America
🇺🇸Miami, Florida, United States
JBR Clinical Research
🇺🇸Salt Lake City, Utah, United States
Research Centers of America
🇺🇸Hollywood, Florida, United States
Colorado Otolaryngology Associates LLC dba Colorado ENT & Allergy
🇺🇸Colorado Springs, Colorado, United States
Eastern Virginia Medical School, Department of Otolaryngology
🇺🇸Norfolk, Virginia, United States
Advanced ENT and Allergy, PLLC
🇺🇸Louisville, Kentucky, United States
Piedmont Ear, Nose & Throat Associates
🇺🇸Winston-Salem, North Carolina, United States
University of South Florida
🇺🇸Tampa, Florida, United States