Trial · NCT03918109
OTO-313 in Subjects With Subjective Tinnitus
NCT03918109, Phase 1, Phase 2, Completed, Otonomy, Inc.; results first posted 2022-12-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. OTO-313 in Subjects With Subjective Tinnitus. Trials, record NCT03918109. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03918109
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- OTO-313 in Subjects With Subjective Tinnitus
- NCT number
- NCT03918109
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 43 participants, actual
- Lead sponsor
- Otonomy, Inc.
- Conditions
- Tinnitus, Subjective
- Interventions
- OTO-313, Placebo
- First posted
- 2019-04-17
- Last updated
- 2022-12-23
- Results first posted
- 2022-12-23
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Other | Change From Baseline in Tinnitus Functional Index (TFI) | 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. |
| Other | Patient Global Impression of Change (PGIC) | 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 |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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]) | decibels | MEAN | |
| PRIMARY | 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]) | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Change From Baseline in Tinnitus Functional Index (TFI) | Up to the End of Study Visit (Part A - Day 29 [4 weeks after the injection]), (Part B - Day 57 [8 weeks after injection]) | score on a scale | MEAN | |
| OTHER_PRE_SPECIFIED | Patient Global Impression of Change (PGIC) | Measured at the end of study visit (Part A - Day 29 [4 weeks after injection]), (Part B - Day 57 [8 weeks after injection]). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Audiometry - Pure Tone Average Done Over 1000, 2000 and 4000 Hertz (HZ) | Part A OTO-313 | -0.3 | Standard Deviation 2.66 | decibels | |
| Audiometry - Pure Tone Average Done Over 1000, 2000 and 4000 Hertz (HZ) | Part A Placebo | 0.71 | Standard Deviation 2.5 | decibels | |
| Audiometry - Pure Tone Average Done Over 1000, 2000 and 4000 Hertz (HZ) | Part B OTO-313 | -0.8 | Standard Deviation 6.44 | decibels | |
| Audiometry - Pure Tone Average Done Over 1000, 2000 and 4000 Hertz (HZ) | Part B Placebo | 0.3 | Standard Deviation 6.95 | decibels | |
| 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)). | Part A OTO-313 | Perforation present: pinhole size | 0 | Participants | |
| 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)). | Part A Placebo | Perforation present: pinhole size | 0 | Participants | |
| 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)). | Part B OTO-313 | Perforation present: pinhole size | 0 | Participants | |
| 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)). | Part B Placebo | Perforation present: pinhole size | 0 | Participants | |
| 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)). | Part A OTO-313 | Perforation present: ≤25% tympanic membrane | 0 | Participants | |
| 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)). | Part A Placebo | Perforation present: ≤25% tympanic membrane | 0 | Participants |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part A OTO-313 | 6 | |
| Overall Study | STARTED | Part A Placebo | 2 | |
| Overall Study | STARTED | Part B OTO-313 | 17 | |
| Overall Study | STARTED | Part B Placebo | 18 | |
| Overall Study | COMPLETED | Part A OTO-313 | 6 | |
| Overall Study | COMPLETED | Part A Placebo | 2 | |
| Overall Study | COMPLETED | Part B OTO-313 | 15 | |
| Overall Study | COMPLETED | Part B Placebo | 16 | |
| Overall Study | NOT COMPLETED | Part A OTO-313 | 0 | |
| Overall Study | NOT COMPLETED | Part A Placebo | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events32
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection Site Discomfort | General disorders | Part A OTO-313 | 1 | 6 | 1 |
| other | Injection Site Discomfort | General disorders | Part A Placebo | 0 | 2 | 0 |
| other | Injection Site Discomfort | General disorders | Part B OTO-313 | 0 | 17 | 0 |
| other | Injection Site Discomfort | General disorders | Part B Placebo | 0 | 18 | 0 |
| other | Injection Site Pain | General disorders | Part A OTO-313 | 1 | 6 | 1 |
| other | Injection Site Pain | General disorders | Part A Placebo | 0 | 2 | 0 |
| other | Injection Site Pain | General disorders | Part B OTO-313 | 0 | 17 | 0 |
| other | Injection Site Pain | General disorders | Part B Placebo | 0 | 18 | 0 |
| other | Injection Site Pruritis | General disorders | Part A OTO-313 | 0 | 6 | 0 |
| other | Injection Site Pruritis | General disorders | Part A Placebo | 1 | 2 | 1 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A OTO-313 | 0 | 6 |
| Total, all-cause mortality | Part A Placebo | 0 | 2 |
| Total, all-cause mortality | Part B OTO-313 | 0 | 17 |
| Total, all-cause mortality | Part B Placebo | 0 | 18 |
| Total, other adverse events | Part A OTO-313 | 2 | 6 |
| Total, other adverse events | Part A Placebo | 1 | 2 |
| Total, other adverse events | Part B OTO-313 | 5 | 17 |
| Total, other adverse events | Part B Placebo | 8 | 18 |
| Total, serious adverse events | Part A OTO-313 | 0 | 6 |
| Total, serious adverse events | Part A Placebo | 0 | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03918109
GET https://conductscience.org/api/trials/v1/NCT03918109/results?page=2