Acute Otitis Externa, Swimmer's Ear
Conditions
Brief summary
This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study in which eligible subjects with acute otitis externa (AOE) will be randomized to receive a single administration of either 12 mg OTO-201 or Sham-Control (empty syringe) to the external auditory canal of the affected ear(s).
Interventions
Single administration of OTO-201
DRUGSham Control
Simulated, single adminstration
Sponsors
Otonomy, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
includes, but is not limited to: * Subject is a male or female age 6 months or older * Subject has a clinical diagnosis of unilateral or bilateral acute 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 eczematoid otitis externa * Subject has diabetes mellitus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Considered a Clinical Cure at Day 8 | At Day 8 (1 week after 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Considered a Clinical Cure at Day 15 | At Day 15 (2 weeks after 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
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 12 mg OTO-201 12 mg ciprofloxacin: single administration | 130 |
| Control Sham Control: Simulated, single administration | 130 |
| Total | 260 |
Baseline characteristics
| Characteristic | 12 mg OTO-201 | Total | Control |
|---|---|---|---|
| Age, Continuous | 36.724 years STANDARD_DEVIATION 20.5866 | 35.760 years STANDARD_DEVIATION 19.9244 | 34.796 years STANDARD_DEVIATION 19.2708 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 41 Participants | 84 Participants | 43 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 87 Participants | 173 Participants | 86 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 29 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) White | 111 Participants | 220 Participants | 109 Participants |
| Region of Enrollment United States | 130 participants | 260 participants | 130 participants |
| Sex: Female, Male Female | 75 Participants | 150 Participants | 75 Participants |
| Sex: Female, Male Male | 55 Participants | 110 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 127 | 0 / 132 |
| other Total, other adverse events | 12 / 127 | 18 / 132 |
| serious Total, serious adverse events | 0 / 127 | 0 / 132 |
Outcome results
Primary
Number of Subjects Considered a Clinical Cure at Day 8
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: At Day 8 (1 week after dosing)
Population: Intent-to-treat analysis set: All subjects who were randomized and did not have Group A Streptococci cultured on Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 12 mg OTO-201 | Number of Subjects Considered a Clinical Cure at Day 8 | 91 Participants |
| Control | Number of Subjects Considered a Clinical Cure at Day 8 | 63 Participants |
Secondary
Number of Subjects Considered a Clinical Cure at Day 15
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: At Day 15 (2 weeks after dosing)
Population: Intent-to-treat analysis set: All subjects who were randomized and and did not have Group A Streptococci cultured on Day 1.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 12 mg OTO-201 | Number of Subjects Considered a Clinical Cure at Day 15 | 97 Participants |
| Control | Number of Subjects Considered a Clinical Cure at Day 15 | 69 Participants |