OTO-313 in Subjects With Unilateral Subjective Tinnitus

Otonomy

Status and phase

Completed

Phase 2

Conditions

Subjective Tinnitus

Treatments

Drug: OTO-313

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04829214

OTO-313-201

Details and patient eligibility

About

The purpose of this study is to determine the efficacy of OTO-313 in subjects with unilateral tinnitus and to determine the safety and tolerability of OTO-313 in subjects with unilateral tinnitus.

Enrollment

153 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject has early-onset subjective unilateral tinnitus that is persistent (consistently aware of their tinnitus throughout much of the waking day).
Subject is able to use the 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, temporomandibular joint disease (TMJ) associated with tinnitus perception, tinnitus resulting from traumatic head or neck injury, or tinnitus resulting from a tumor or stroke.
Subject is pregnant, lactating, or undergoing fertility treatment.
Subject has other clinically significant illness, medical condition or medical history at Screening or Baseline that, in the Investigator's opinion, would likely reduce the safety of study participation or compliance with study procedures.