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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
110
Colorado Otolaryngology Associates LLC dba Colorado ENT & Allergy
Colorado Springs, Colorado, United States
Research Centers of America
Hollywood, Florida, United States
South Florida ENT Associates or Research Centers of America
Miami, Florida, United States
Treatment Emergent Adverse Events (Safety)
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.
Time frame: Reported or observed during or after dosing (Day 1) up to the end of study (Day 85 - 12 weeks after dosing)
Otoscopic Examinations (Safety)
Clinically significant change form Baseline
Time frame: After dosing (Day 1) up to end of study (Day 85 - 12 weeks after dosing)
Audiometry (Safety)
Clinically significant change from Baseline
Time frame: After dosing (Day 1) up to end of study (Day 85 - 12 weeks after dosing)
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University of South Florida
Tampa, Florida, United States
Advanced ENT and Allergy, PLLC
Louisville, Kentucky, United States
Piedmont Ear, Nose & Throat Associates
Winston-Salem, North Carolina, United States
JBR Clinical Research
Salt Lake City, Utah, United States
Eastern Virginia Medical School, Department of Otolaryngology
Norfolk, Virginia, United States