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
Who is this study for? Patients with Sensorineural Hearing Loss
What treatments are being studied? OTO-413
Status: Completed
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 64
Healthy Volunteers: f
View:
• 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.
Locations
United States
Colorado
Colorado Otolaryngology Associates LLC dba Colorado ENT & Allergy
Colorado Springs
Florida
Research Centers of America
Hollywood
South Florida ENT Associates or Research Centers of America
Miami
University of South Florida
Tampa
Kentucky
Advanced ENT and Allergy, PLLC
Louisville
North Carolina
Piedmont Ear, Nose & Throat Associates
Winston-salem
Utah
JBR Clinical Research
Salt Lake City
Virginia
Eastern Virginia Medical School, Department of Otolaryngology
Norfolk
Time Frame
Start Date: 2019-10-01
Completion Date: 2022-09-05
Participants
Target number of participants: 110
Treatments
Experimental: OTO-413
Placebo_comparator: Placebo
Authors
Related Therapeutic Areas
Sponsors
Leads: Otonomy, Inc.