Otitis Media
Conditions
Keywords
Otitis media, Ear infection, Tympanostomy tubes
Brief summary
This is an 8-week, multicenter, open-label study in which eligible subjects with a history of otitis media requiring TT placement will receive 6 mg OTO-201 to each ear. The study is designed to evaluate the safety and efficacy of OTO-201 in subjects undergoing TT placement with common concurrent surgeries and any middle ear effusion status.
Interventions
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 history of otitis media requiring bilateral tympanostomy tube placement * 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 a history of prior ear or mastoid surgery, not including myringotomy or myringotomy with TT placement * Subject has been designated for any other surgical procedure that would occur concurrently with TT placement, except adenoidectomy, airway endoscopy, nasal endoscopy, and nasal cautery for epistaxis * Subject has a history of sensorineural hearing loss
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Post-surgical Otorrhea | Week 4 | Absence or presence of otorrhea (drainage from the middle ear) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Burden - Ear Discharge Control | Week 4 | Ear Drop Caregiver Burden Questionnaire at Week 4 |
| Adverse Events | Up to Eight Weeks | Evaluation of adverse events |
| Caregiver Burden - Ear Drops Administration | Week 8 | Ear Drop Caregiver Burden Questionnaire at Week 8 |
Countries
United States
Participant flow
Pre-assignment details
There were a total of 518 subjects screened for this study. There were 17 subjects considered screen failures, with the majority (11) failing to meet inclusion/exclusion criteria. Therefore, 501 subjects were assigned for treatment in this study and are designated as enrolled.
Participants by arm
| Arm | Count |
|---|---|
| 6 mg OTO-201 6 mg ciprofloxacin: single administration | 501 |
| Total | 501 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 20 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | 6 mg OTO-201 |
|---|---|
| Age, Categorical <=18 years | 501 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 2.9 years STANDARD_DEVIATION 2.54 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 80 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 403 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 18 Participants |
| Medicaid (Yes/No) Medicaid - No | 336 Participants |
| Medicaid (Yes/No) Medicaid - Yes | 165 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 40 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 36 Participants |
| Race (NIH/OMB) White | 415 Participants |
| Region of Enrollment United States | 501 participants |
| Sex: Female, Male Female | 216 Participants |
| Sex: Female, Male Male | 285 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 501 |
| other Total, other adverse events | 200 / 501 |
| serious Total, serious adverse events | 1 / 501 |
Outcome results
Primary
Number of Subjects With Post-surgical Otorrhea
Absence or presence of otorrhea (drainage from the middle ear)
Time frame: Week 4
Population: Safety analysis set: All subjects who received study drug.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 6 mg OTO-201 | Number of Subjects With Post-surgical Otorrhea | Absence of Otorrhea | 383 Participants |
| 6 mg OTO-201 | Number of Subjects With Post-surgical Otorrhea | Presence of Otorrhea | 118 Participants |
Primary
Number of Subjects With Post-surgical Otorrhea
Absence or presence of otorrhea (drainage from the middle ear)
Time frame: 8 weeks
Population: Safety analysis set: All subjects who received study drug
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 6 mg OTO-201 | Number of Subjects With Post-surgical Otorrhea | Absence of Otorrhea | 334 Participants |
| 6 mg OTO-201 | Number of Subjects With Post-surgical Otorrhea | Presence of Otorrhea | 167 Participants |
Secondary
Adverse Events
Evaluation of adverse events
Time frame: Up to Eight Weeks
Population: Safety analysis set: All subjects who received study drug.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 6 mg OTO-201 | Adverse Events | Subjects with AEs | 250 Participants |
| 6 mg OTO-201 | Adverse Events | Subjects without AEs | 251 Participants |
Secondary
Caregiver Burden - Ear Discharge Control
Ear Drop Caregiver Burden Questionnaire at Week 4
Time frame: Week 4
Population: Safety analysis set: All subjects who received study drug and whose caregiver completed the questionnaire at Week 4
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 6 mg OTO-201 | Caregiver Burden - Ear Discharge Control | Satisfied with control of ear discharge | 481 Participants |
| 6 mg OTO-201 | Caregiver Burden - Ear Discharge Control | Not satisfied with control of ear discharge | 4 Participants |
Secondary
Caregiver Burden - Ear Discharge Control
Ear Drop Caregiver Burden Questionnaire at Week 8
Time frame: Week 8
Population: Safety analysis set: All subjects who received study drug, and had a completed questionnaire at Week 8
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 6 mg OTO-201 | Caregiver Burden - Ear Discharge Control | Satisfied with control of ear discharge | 470 Participants |
| 6 mg OTO-201 | Caregiver Burden - Ear Discharge Control | Not satisfied with control of ear discharge | 5 Participants |
Secondary
Caregiver Burden - Ear Drops Administration
Ear Drop Caregiver Burden Questionnaire at Week 8
Time frame: Week 8
Population: Safety analysis set: All subject who received study drug, and who had to be treated with ear drops after tube placement surgery.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 6 mg OTO-201 | Caregiver Burden - Ear Drops Administration | Bothersome to administer ear drops | 48 Participants |
| 6 mg OTO-201 | Caregiver Burden - Ear Drops Administration | Not bothersome to administer ear drops | 23 Participants |