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OTO-313 in Subjects With Subjective Tinnitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03918109
Recruitment Status : Completed
First Posted : April 17, 2019
Results First Posted : December 23, 2022
Last Update Posted : December 23, 2022
Information provided by (Responsible Party):
Otonomy, Inc.

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.

Condition or disease Intervention/treatment Phase
Tinnitus, Subjective Drug: OTO-313 Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, placebo-controlled, multicenter
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Phase 1/2 Study of OTO-313 Given as a Single Intratympanic Injection in Subjects With Subjective Tinnitus
Actual Study Start Date : April 4, 2019
Actual Primary Completion Date : May 29, 2020
Actual Study Completion Date : May 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arm Intervention/treatment
Experimental: OTO-313 Drug: OTO-313
single intratympanic injection of gacyclidine

Placebo Comparator: Placebo Drug: Placebo
single intratympanic injection of placebo

Primary Outcome Measures :
  1. Audiometry - Pure Tone Average Done Over 1000, 2000 and 4000 Hertz (HZ) [ Time Frame: 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.

  2. 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)). [ 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]) ]
    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.

Other Outcome Measures:
  1. Change From Baseline in Tinnitus Functional Index (TFI) [ Time Frame: Up to the End of Study Visit (Part A - Day 29 [4 weeks after the injection]), (Part B - Day 57 [8 weeks after injection]) ]
    Validated, 25-item questionnaire; index score from 0 to 100; a negative change indicates improvement. The 25 items of the TFI represent 8 subscales covering multiple domains of tinnitus severity: 1) Intrusive, 2) Sense of Control, 3) Cognitive, 4) Sleep, 5) Auditory, 6) Relaxation, 7) Quality of Life, and 8) Emotional. Subjects answer each TFI question by rating their experience over the past week. Each subscale has 3 questions with a response ranging from 0 (best response) to 10 (worst response) in regard to the impact of tinnitus in these different aspects of the subject's life. The highest raw score would be 250 and the lowest would be 0. The raw score is then divided by the total number of valid answers and that in turn is multiplied by 10 to give an overall score range from 0-100, with 0 representing no impact of tinnitus on their daily life and 100 representing complete impact of tinnitus on their daily life.

  2. Patient Global Impression of Change (PGIC) [ Time Frame: Measured at the end of study visit (Part A - Day 29 [4 weeks after injection]), (Part B - Day 57 [8 weeks after injection]). ]

    Change in overall tinnitus status as perceived by the subject; this was a subject-reported outcome that evaluated the change in overall "global" tinnitus status as perceived by the subject. The subject was asked: "Since the beginning of the clinical study, how would you rate your tinnitus?".

    The beginning of the clinical study in this context was the time prior to investigational product administration. The 7 response categories (and point scores) for the PGIC are:

    • Very much improved = 3
    • Much improved = 2
    • Minimally improved = 1
    • Unchanged = 0
    • Minimally worse = -1
    • Much worse = -2
    • Very much worse = -3

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03918109

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United States, California
House Clinic
Los Angeles, California, United States, 90057
California Head & Neck Specialists
San Diego, California, United States, 92121
United States, Colorado
Colorado ENT and Allergy
Colorado Springs, Colorado, United States, 80909
United States, Florida
Silverstein Institute/Ear Research Foundation
Sarasota, Florida, United States, 34239
United States, Illinois
Chicago, Illinois, United States, 60657
United States, Kentucky
Advanced ENT and Allergy
Louisville, Kentucky, United States, 40207
United States, Louisiana
Tandem Clinical Research, LLC
Marrero, Louisiana, United States, 70072
United States, New Jersey
Summit Medical Group
Berkeley Heights, New Jersey, United States, 10882
United States, New York
Dent Neurosciences Research Center
Amherst, New York, United States, 14226
Northwell Health, Hearing & Speech Center
New Hyde Park, New York, United States, 11042
Northwell Health at ENT and Allergy Associates
White Plains, New York, United States, 10605
United States, North Carolina
Charlotte Eye Ear Nose & Throat Associates
Charlotte, North Carolina, United States, 28210
Piedmont Ear, Nose, and Throat Associates
Winston-Salem, North Carolina, United States, 27103
United States, Texas
Worldwide Clinical Trials
San Antonio, Texas, United States, 78217
United States, Utah
Chrysalis Clinical Research
Saint George, Utah, United States, 84790
United States, West Virginia
WVU Medicine
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Otonomy, Inc.
  Study Documents (Full-Text)

Documents provided by Otonomy, Inc.:
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Responsible Party: Otonomy, Inc.
ClinicalTrials.gov Identifier: NCT03918109    
Other Study ID Numbers: 313-201901
First Posted: April 17, 2019    Key Record Dates
Results First Posted: December 23, 2022
Last Update Posted: December 23, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Otonomy, Inc.:
tinnitus, intratympanic injection, gacyclidine
Additional relevant MeSH terms:
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Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases