The purpose of this study is to evaluate the safety, tolerability, plasma pharmacokinetics (PK), and exploratory efficacy of OTO-313 administered as an intratympanic injection for the treatment of subjective tinnitus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
43
House Clinic
Los Angeles, California, United States
California Head & Neck Specialists
San Diego, California, United States
Audiometry - Pure Tone Average Done Over 1000, 2000 and 4000 Hertz (HZ)
Mean Change from Baseline to End of Study (baseline to Day 29 \[4 weeks after dosing\](Part A) or baseline to Day 57 \[8 weeks after dosing\] (Part B)). in Pure Tone Average Hearing Thresholds; a negative change indicates improvement.
Time frame: Up to end of study (Part A - Day 29 [4 weeks after dosing]), (Part B - Day 57 [8 weeks after dosing])
Otoscopic Examination - Presence of Perforation in the Treated Ear at the End of Study Visit (Day 29 [4 Weeks After Dosing] (Part A) or Day 57 [8 Weeks After Dosing] (Part B)).
Ear examinations were done at every visit. One of the important safety endpoints was an observation of a perforation in the ear drum that did not heal properly after the injection.
Time frame: Up to end of study (Part A - Day 29 [4 weeks after the injection], Part B - Day 57 [8 weeks after the injection])
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Colorado ENT and Allergy
Colorado Springs, Colorado, United States
Silverstein Institute/Ear Research Foundation
Sarasota, Florida, United States
ChicagoENT
Chicago, Illinois, United States
Advanced ENT and Allergy
Louisville, Kentucky, United States
Tandem Clinical Research, LLC
Marrero, Louisiana, United States
Summit Medical Group
Berkeley Heights, New Jersey, United States
Dent Neurosciences Research Center
Amherst, New York, United States
Northwell Health, Hearing & Speech Center
New Hyde Park, New York, United States
...and 6 more locations