Bilateral Middle Ear Effusion
Conditions
Brief summary
This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with bilateral middle ear effusion requiring tympanostomy tube placement. Eligible subjects will receive a single dose to each ear of 6 mg OTO-201, administered intraoperatively into the middle ear through the lumen of the tympanostomy tube (trans-tympanostomy tube TTT). The study is designed to characterize safety and any procedural issues associated with TTT drug administration of OTO-201.
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 bilateral middle ear effusion requiring tympanostomy tube placement * 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 prior ear or mastoid surgery, not including myringotomy or myringotomy with tympanostomy tube placement * Subject has a history of sensorineural hearing loss * Subject has been designated for any other surgical procedure that would occur concurrently with TT placement, such as, but not limited to adenoidectomy or tonsillectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Otoscopic Examination: Auricle and Meatus | Up to 1 month | Number of ears whose external ear and ear canal (auricle and meatus), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29 |
| Otoscopic Examination: Tympanic Membrane | up to 1 month | Number of ears whose ear drum (tympanic membrane), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29 |
| Otoscopic Examination: Tube Patency | Up to 1 month | Subjects with at least one ear tube patent (i.e., not blocked) at Day 29 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Administration | Day 1 | Ease of administering OTO-201 through the tympanostomy tube: Number of subjects that investigators rated ease of administration as either easy or very easy |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 6 mg OTO-201 6 mg ciprofloxacin: single Trans-Tympanic Tube Administration | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | 6 mg OTO-201 |
|---|---|
| Age, Categorical <=18 years | 33 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 2.92 years STANDARD_DEVIATION 2.465 |
| Age, Customized >2 years | 16 Participants |
| Age, Customized 6 months to 2 years | 17 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 6 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 | 2 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Region of Enrollment United States | 33 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 33 |
| other Total, other adverse events | 20 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
Primary
Otoscopic Examination: Auricle and Meatus
Number of ears whose external ear and ear canal (auricle and meatus), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29
Time frame: Up to 1 month
Population: Safety analysis set : consisted of all enrolled and treated subjects
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| 6mg OTO-201 | Otoscopic Examination: Auricle and Meatus | 1 ears |
Primary
Otoscopic Examination: Tube Patency
Subjects with at least one ear tube patent (i.e., not blocked) at Day 29
Time frame: Up to 1 month
Population: Safety analysis set: all enrolled and treated subjects
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 6mg OTO-201 | Otoscopic Examination: Tube Patency | 32 Participants |
Primary
Otoscopic Examination: Tympanic Membrane
Number of ears whose ear drum (tympanic membrane), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29
Time frame: up to 1 month
Population: Safety analysis set: all enrolled and treated subjects
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| 6mg OTO-201 | Otoscopic Examination: Tympanic Membrane | 2 ears |
Secondary
Feasibility of Administration
Ease of administering OTO-201 through the tympanostomy tube: Number of subjects that investigators rated ease of administration as either easy or very easy
Time frame: Day 1
Population: Safety analysis set consisted of all enrolled and treated subjects
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 6mg OTO-201 | Feasibility of Administration | 29 Participants |