Trial · NCT02511561
OTO-201 for the Treatment of Otitis Externa
NCT02511561, Phase 2, Completed, Otonomy, Inc.; results first posted 2020-09-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. OTO-201 for the Treatment of Otitis Externa. Trials, record NCT02511561. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02511561
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- OTO-201 for the Treatment of Otitis Externa
- NCT number
- NCT02511561
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 75 participants, actual
- Lead sponsor
- Otonomy, Inc.
- Conditions
- Otitis Externa
- Interventions
- OTO-201 (ciprofloxacin)
- First posted
- 2015-07-30
- Last updated
- 2020-10-19
- Results first posted
- 2020-09-22
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Otoscopic Examination: Tympanic Membrane | Up to 1 month | Number of subjects with a tympanic membrane that was rated as "Not able to Visualize" or "Abnormal" at Baseline that was rated as "Normal" at Day 29 (final study day) |
| Primary | Otoscopic Examination: Middle Ear | Up to 1 month | Number of subjects with a middle ear that was rated as "Not Able to Visualize" or "Abnormal" at Baseline that had a middle ear rated as "Normal" at Day 29 (final study visit) |
| Primary | Feasibility of Administration | Day1 | Ease of administering OTO-201 to the external ear canal. Number of subjects that investigators rated ease of administration as either "easy" or "very easy". |
| Primary | Overall Adverse Events | up to 1 month | Number of Subjects with and without adverse events during the study from dosing up to 1 month after dosing |
| Secondary | Number of Subjects Considered a Clinical Cure at Day 15 (Intent-to-treat Analysis Set) | Day 15 (two weeks from dosing) | Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows: None = 0 Mild = 1 Moderate = 2 Severe = 3 |
| Secondary | Number of Subjects Considered a Clinical Cure at Day 15 (Per-protocol Analysis Set) | Day 15 (2 weeks from dosing) | Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows: None = 0 Mild = 1 Moderate = 2 Severe = 3 |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Otoscopic Examination: Tympanic Membrane | Up to 1 month | Safety analysis set: All subjects who received study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Otoscopic Examination: Middle Ear | Up to 1 month | Safety analysis set: All subjects that received drug | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Feasibility of Administration | Day1 | Safety analysis set: All subjects who receieved study drug | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Overall Adverse Events | up to 1 month | Safety analysis set: All subjects that received study drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Considered a Clinical Cure at Day 15 (Intent-to-treat Analysis Set) | Day 15 (two weeks from dosing) | Intent-to-treat analysis set: All subjects who were randomized and were used for assessments of clinical activity | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Considered a Clinical Cure at Day 15 (Per-protocol Analysis Set) | Day 15 (2 weeks from dosing) | Per-protocol Analysis Set defined as all subjects in the ITT analysis set who received study drug, completed Visit 4 (Day 15), and did not have a major protocol deviation. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Otoscopic Examination: Tympanic Membrane | 6 mg OTO-201 | 6 | Participants | ||
| Otoscopic Examination: Tympanic Membrane | 12 mg OTO-201 | 8 | Participants | ||
| Otoscopic Examination: Tympanic Membrane | 24 mg OTO-201 | 8 | Participants | ||
| Otoscopic Examination: Middle Ear | 6 mg OTO-201 | 8 | Participants | ||
| Otoscopic Examination: Middle Ear | 12 mg OTO-201 | 7 | Participants | ||
| Otoscopic Examination: Middle Ear | 24 mg OTO-201 | 8 | Participants | ||
| Feasibility of Administration | 6 mg OTO-201 | 24 | Participants | ||
| Feasibility of Administration | 12 mg OTO-201 | 25 | Participants | ||
| Feasibility of Administration | 24 mg OTO-201 | 25 | Participants | ||
| Overall Adverse Events | 6 mg OTO-201 | Number of subjects with at least 1 adverse event | 8 | Participants |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 6 mg OTO-201 | 25 | |
| Overall Study | STARTED | 12 mg OTO-201 | 25 | |
| Overall Study | STARTED | 24 mg OTO-201 | 25 | |
| Overall Study | COMPLETED | 6 mg OTO-201 | 25 | |
| Overall Study | COMPLETED | 12 mg OTO-201 | 25 | |
| Overall Study | COMPLETED | 24 mg OTO-201 | 25 | |
| Overall Study | NOT COMPLETED | 6 mg OTO-201 | 0 | |
| Overall Study | NOT COMPLETED | 12 mg OTO-201 | 0 | |
| Overall Study | NOT COMPLETED | 24 mg OTO-201 | 0 |
Source ClinicalTrials.gov
Adverse events9
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 | Otitis externa | Infections and infestations | 6 mg OTO-201 | 2 | 25 | |
| other | Otitis externa | Infections and infestations | 12 mg OTO-201 | 3 | 25 | |
| other | Otitis externa | Infections and infestations | 24 mg OTO-201 | 4 | 25 | |
| other | Ear pain | Ear and labyrinth disorders | 6 mg OTO-201 | 0 | 25 | |
| other | Ear pain | Ear and labyrinth disorders | 12 mg OTO-201 | 1 | 25 | |
| other | Ear pain | Ear and labyrinth disorders | 24 mg OTO-201 | 3 | 25 | |
| other | Hypacusis | Ear and labyrinth disorders | 6 mg OTO-201 | 0 | 25 | |
| other | Hypacusis | Ear and labyrinth disorders | 12 mg OTO-201 | 1 | 25 | |
| other | Hypacusis | Ear and labyrinth disorders | 24 mg OTO-201 | 3 | 25 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 6 mg OTO-201 | 0 | 25 |
| Total, all-cause mortality | 12 mg OTO-201 | 0 | 25 |
| Total, all-cause mortality | 24 mg OTO-201 | 0 | 25 |
| Total, other adverse events | 6 mg OTO-201 | 2 | 25 |
| Total, other adverse events | 12 mg OTO-201 | 5 | 25 |
| Total, other adverse events | 24 mg OTO-201 | 10 | 25 |
| Total, serious adverse events | 6 mg OTO-201 | 0 | 25 |
| Total, serious adverse events | 12 mg OTO-201 | 0 | 25 |
| Total, serious adverse events | 24 mg OTO-201 | 0 | 25 |
Source ClinicalTrials.gov
Papers0
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/NCT02511561
GET https://conductscience.org/api/trials/v1/NCT02511561/results?page=2