Otitis Externa
Conditions
Keywords
Otitis externa, Swimmer's ear, Ear infection
Brief summary
This is a 1-month, multicenter, open-label study in subjects with unilateral otitis externa. Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear. The study is designed to characterize safety, procedural factors and clinical effect of OTO-201 administered in subjects with otitis externa.
Interventions
Sponsors
Otonomy, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 80 Years
Healthy volunteers
No
Inclusion criteria
includes, but is not limited to: * Subject is a male or female aged 6 months to 80 years, inclusive * Subject has a clinical diagnosis of unilateral otitis externa * Subject or subject's caregiver is willing to comply with the protocol and attend all study visits
Exclusion criteria
includes, but is not limited to: * Subject has tympanic membrane perforation * Subject has a history of known immunodeficiency disease * Subject has fungal otitis externa, based on clinical signs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 6 mg OTO-201 6 mg ciprofloxacin: single administration | 25 |
| 12 mg OTO-201 12 mg ciprofloxacin: single administration | 25 |
| 24 mg OTO-201 24 mg ciprofloxacin: single administration | 25 |
| Total | 75 |
Baseline characteristics
| Characteristic | 6 mg OTO-201 | Total | 24 mg OTO-201 | 12 mg OTO-201 |
|---|---|---|---|---|
| Age, Continuous | 38.8 years STANDARD_DEVIATION 21.95 | 37.3 years STANDARD_DEVIATION 22.37 | 43.0 years STANDARD_DEVIATION 23.74 | 30.0 years STANDARD_DEVIATION 20.12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 12 Participants | 2 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 63 Participants | 23 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 11 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 22 Participants | 61 Participants | 18 Participants | 21 Participants |
| Region of Enrollment United States | 25 participants | 75 participants | 25 participants | 25 participants |
| Sex: Female, Male Female | 12 Participants | 35 Participants | 12 Participants | 11 Participants |
| Sex: Female, Male Male | 13 Participants | 40 Participants | 13 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 2 / 25 | 5 / 25 | 10 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 25 |
Outcome results
Primary
Feasibility of Administration
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.
Time frame: Day1
Population: Safety analysis set: All subjects who receieved study drug
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 6 mg OTO-201 | Feasibility of Administration | 24 Participants |
| 12 mg OTO-201 | Feasibility of Administration | 25 Participants |
| 24 mg OTO-201 | Feasibility of Administration | 25 Participants |
Primary
Otoscopic Examination: Middle Ear
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)
Time frame: Up to 1 month
Population: Safety analysis set: All subjects that received drug
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 6 mg OTO-201 | Otoscopic Examination: Middle Ear | 8 Participants |
| 12 mg OTO-201 | Otoscopic Examination: Middle Ear | 7 Participants |
| 24 mg OTO-201 | Otoscopic Examination: Middle Ear | 8 Participants |
Primary
Otoscopic Examination: Tympanic Membrane
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)
Time frame: Up to 1 month
Population: Safety analysis set: All subjects who received study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 6 mg OTO-201 | Otoscopic Examination: Tympanic Membrane | 6 Participants |
| 12 mg OTO-201 | Otoscopic Examination: Tympanic Membrane | 8 Participants |
| 24 mg OTO-201 | Otoscopic Examination: Tympanic Membrane | 8 Participants |
Primary
Overall Adverse Events
Number of Subjects with and without adverse events during the study from dosing up to 1 month after dosing
Time frame: up to 1 month
Population: Safety analysis set: All subjects that received study drug
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 6 mg OTO-201 | Overall Adverse Events | Number of subjects with at least 1 adverse event | 8 Participants |
| 6 mg OTO-201 | Overall Adverse Events | Number of subjects with no adverse events | 17 Participants |
| 12 mg OTO-201 | Overall Adverse Events | Number of subjects with at least 1 adverse event | 9 Participants |
| 12 mg OTO-201 | Overall Adverse Events | Number of subjects with no adverse events | 16 Participants |
| 24 mg OTO-201 | Overall Adverse Events | Number of subjects with at least 1 adverse event | 13 Participants |
| 24 mg OTO-201 | Overall Adverse Events | Number of subjects with no adverse events | 12 Participants |
Secondary
Number of Subjects Considered a Clinical Cure at Day 15 (Intent-to-treat Analysis Set)
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
Time frame: Day 15 (two weeks from dosing)
Population: Intent-to-treat analysis set: All subjects who were randomized and were used for assessments of clinical activity
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 6 mg OTO-201 | Number of Subjects Considered a Clinical Cure at Day 15 (Intent-to-treat Analysis Set) | 14 Participants |
| 12 mg OTO-201 | Number of Subjects Considered a Clinical Cure at Day 15 (Intent-to-treat Analysis Set) | 19 Participants |
| 24 mg OTO-201 | Number of Subjects Considered a Clinical Cure at Day 15 (Intent-to-treat Analysis Set) | 16 Participants |
Secondary
Number of Subjects Considered a Clinical Cure at Day 15 (Per-protocol Analysis Set)
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
Time frame: Day 15 (2 weeks from dosing)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 6 mg OTO-201 | Number of Subjects Considered a Clinical Cure at Day 15 (Per-protocol Analysis Set) | 13 Participants |
| 12 mg OTO-201 | Number of Subjects Considered a Clinical Cure at Day 15 (Per-protocol Analysis Set) | 19 Participants |
| 24 mg OTO-201 | Number of Subjects Considered a Clinical Cure at Day 15 (Per-protocol Analysis Set) | 15 Participants |