OTO-313 in Subjects With Subjective Tinnitus

Otonomy

Status and phase

Completed

Phase 2

Phase 1

Conditions

Tinnitus, Subjective

Treatments

Drug: OTO-313

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03918109

313-201901

Details and patient eligibility

About

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.

Enrollment

43 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.