OTO-313 in Subjects With Subjective Tinnitus

Phase 1

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Subject has subjective unilateral tinnitus and is consistently aware of their tinnitus throughout much of the waking day.
Subject is able to use the electronic diary to complete their daily tinnitus ratings
Subject's tinnitus is likely of cochlear origin, e.g., associated with sensorineural hearing loss; acute hearing loss from noise trauma, barotrauma, or traumatic cochlear injury (acute acoustic trauma, blast trauma, middle ear surgery, inner ear barotrauma); age-related hearing loss; resolved otitis media; ototoxic drug exposure.
Subject is willing to comply with the protocol and attend all study visits.

Exclusion Criteria

Subject has pulsatile tinnitus, tinnitus resulting from traumatic head or neck injury, or tinnitus resulting from a tumor or stroke.
Subject is pregnant or lactating.
Subject has other clinically significant illness, medical condition or medical history at Screening or Baseline (Day 1) that, in the Investigator's opinion, would likely reduce the safety of study participation or compliance with study procedures.

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
OTO-313	OTO-313	-

Primary Outcome Measures

Name	Time	Method
Audiometry - Pure Tone Average Done Over 1000, 2000 and 4000 Hertz (HZ)	Up to end of study (Part A - Day 29 [4 weeks after dosing]), (Part B - Day 57 [8 weeks after dosing])	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.
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)).	Up to end of study (Part A - Day 29 [4 weeks after the injection], Part B - Day 57 [8 weeks after the injection])	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.

Secondary Outcome Measures

Name	Time	Method

Locations (16): WVU Medicine
🇺🇸
Morgantown, West Virginia, United States
Silverstein Institute/Ear Research Foundation
🇺🇸
Sarasota, Florida, United States
California Head & Neck Specialists
🇺🇸
San Diego, California, United States
Advanced ENT and Allergy
🇺🇸
Louisville, Kentucky, United States
House Clinic
🇺🇸
Los Angeles, California, United States
Colorado ENT and Allergy
🇺🇸
Colorado Springs, Colorado, United States
Summit Medical Group
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Berkeley Heights, New Jersey, United States
Dent Neurosciences Research Center
🇺🇸
Amherst, New York, United States
Tandem Clinical Research, LLC
🇺🇸
Marrero, Louisiana, United States
Charlotte Eye Ear Nose & Throat Associates
🇺🇸
Charlotte, North Carolina, United States
Chrysalis Clinical Research
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Saint George, Utah, United States
Worldwide Clinical Trials
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San Antonio, Texas, United States
ChicagoENT
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Chicago, Illinois, United States
Northwell Health, Hearing & Speech Center
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New Hyde Park, New York, United States
Northwell Health at ENT and Allergy Associates
🇺🇸
White Plains, New York, United States
Piedmont Ear, Nose, and Throat Associates
🇺🇸
Winston-Salem, North Carolina, United States