Acute Otitis Media, AOMT
Conditions
Keywords
Acute otitis media with tympanostomy tubes
Brief summary
This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT). Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear(s). The study is designed to characterize safety, procedural factors and clinical effect of OTO-201 administered in subjects with AOMT.
Interventions
DRUGOTO-201
Sponsors
Otonomy, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 17 Years
Healthy volunteers
No
Inclusion criteria
includes, but is not limited to: * Subject is a male or female aged 6 months to 17 years, inclusive * Subject has a clinical diagnosis of acute otitis media with tympanostomy tubes (AOMT) * Subject's caregiver is willing to comply with the protocol an attend all study visits
Exclusion criteria
includes, but is not limited to: * Subject has a history of sensorineural hearing loss * Subject has tympanic membrane perforation other than the surgical tympanostomy tube perforation * Subject has a history of known immunodeficiency disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Ears With Otorrhea (Drainage From the Middle Ear) | Day 29 | Acute otitis media with tympanostomy tubes in place (AOMT) refers to subjects that have ear tubes present, but have a middle ear infection. Otorrhea is fluid drainage from the middle ear. This outcome is assessed during the otoscopic examination of each affected ear (the ear with the infection). All subjects have otorrhea in the affected ear at Baseline and the assessment is done after administering OTO-201 to be sure there is no infection remaining or no new infection. |
| Feasibility of Administration Questionnaire | Day 1 | Issues Administering OTO-201 onto the Tympanic Membrane and the Auditory Canal-facing Side of the Tympanostomy Tube (answered yes) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Ears With no More Otorrhea (Drainage From the Middle Ear) | Day 15 | Acute otitis media with tympanostomy tubes in place (AOMT) refers to subjects that have ear tubes present, but have a middle ear infection. Otorrhea is fluid drainage from the middle ear. This outcome is assessed during the otoscopic examination of each affected ear (the ear with the infection). All subjects have otorrhea in the affected ear at Baseline and the assessment is done 15 days after administering OTO-201 to see if it worked and there is no more drainage from the middle ear. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OTO-201 6 mg OTO-201
OTO-201 | 39 |
| Total | 39 |
Baseline characteristics
| Characteristic | OTO-201 |
|---|---|
| Age, Continuous | 2.16 years STANDARD_DEVIATION 1.17 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Region of Enrollment United States | 39 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 39 |
| other Total, other adverse events | 23 / 39 |
| serious Total, serious adverse events | 0 / 39 |
Outcome results
Primary
Feasibility of Administration Questionnaire
Issues Administering OTO-201 onto the Tympanic Membrane and the Auditory Canal-facing Side of the Tympanostomy Tube (answered yes)
Time frame: Day 1
Population: Safety analysis set: All enrolled and treated subjects.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| OTO-201 | Feasibility of Administration Questionnaire | 2 ears |
Primary
Number of Ears With Otorrhea (Drainage From the Middle Ear)
Acute otitis media with tympanostomy tubes in place (AOMT) refers to subjects that have ear tubes present, but have a middle ear infection. Otorrhea is fluid drainage from the middle ear. This outcome is assessed during the otoscopic examination of each affected ear (the ear with the infection). All subjects have otorrhea in the affected ear at Baseline and the assessment is done after administering OTO-201 to be sure there is no infection remaining or no new infection.
Time frame: Day 29
Population: Safety analysis set: All enrolled and treated subjects; subjects could have either unilateral or bilateral (one ear or both ears) acute otitis media with tympanostomy tubes in place (AOMT)
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| OTO-201 | Number of Ears With Otorrhea (Drainage From the Middle Ear) | 8 affected ears |
Secondary
Number of Ears With no More Otorrhea (Drainage From the Middle Ear)
Acute otitis media with tympanostomy tubes in place (AOMT) refers to subjects that have ear tubes present, but have a middle ear infection. Otorrhea is fluid drainage from the middle ear. This outcome is assessed during the otoscopic examination of each affected ear (the ear with the infection). All subjects have otorrhea in the affected ear at Baseline and the assessment is done 15 days after administering OTO-201 to see if it worked and there is no more drainage from the middle ear.
Time frame: Day 15
Population: Safety analysis set: All enrolled and treated subjects
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| OTO-201 | Number of Ears With no More Otorrhea (Drainage From the Middle Ear) | 50 affected ears |