OTO-313 in Subjects with Unilateral Subjective Tinnitus

  • STATUS
    Recruiting
  • sponsor
    Otonomy
Updated on 13 April 2021

Summary

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.

Description


Details
Condition Tinnitus
Clinical Study IdentifierTX271120
SponsorOtonomy
Last Modified on13 April 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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