Open-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: OTO-201 6 mg OTO-201 administered trans-tympanostomy tube |
Drug: OTO-201
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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"
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Central California Ear, Nose and Throat | Fresno | California | United States | |
| 2 | Charlotte Eye, Ear, Nose and Throat Associates | Charlotte | North Carolina | United States | |
| 3 | Charlotte Eye, Ear, Nose and Throat Associates | Matthews | North Carolina | United States | |
| 4 | Piedmont Ear, Nose and Throat | Winston-Salem | North Carolina | United States | |
| 5 | Carolina Ear, Nose and Throat | Orangeburg | South Carolina | United States |
Sponsors and Collaborators
- Otonomy, Inc.
Investigators
- Study Chair: Carl LeBel, PhD, Otonomy, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 201-201404
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | 6 mg OTO-201 |
|---|---|
| Arm/Group Description | 6 mg ciprofloxacin: single Trans-Tympanic Tube Administration |
| Period Title: Overall Study | |
| STARTED | 33 |
| COMPLETED | 33 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | 6 mg OTO-201 |
|---|---|
| Arm/Group Description | 6 mg ciprofloxacin: single Trans-Tympanic Tube Administration |
| Overall Participants | 33 |
| Age (Count of Participants) | |
| <=18 years |
33
100%
|
| Between 18 and 65 years |
0
0%
|
| >=65 years |
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
2.92
(2.465)
|
| Age, Customized (Count of Participants) | |
| 6 months to 2 years |
17
51.5%
|
| >2 years |
16
48.5%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
11
33.3%
|
| Male |
22
66.7%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
2
6.1%
|
| Not Hispanic or Latino |
31
93.9%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
2
6.1%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
6
18.2%
|
| White |
23
69.7%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
2
6.1%
|
| Region of Enrollment (participants) [Number] | |
| United States |
33
100%
|
Outcome Measures
| Title | Otoscopic Examination: Auricle and Meatus |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set : consisted of all enrolled and treated subjects |
| Arm/Group Title | 6mg OTO-201 |
|---|---|
| Arm/Group Description | 6 mg ciprofloxacin: single Trans-Tympanic Tube Administration |
| Measure Participants | 33 |
| Measure ears | 66 |
| Count of Units [ears] |
1
|
| Title | Otoscopic Examination: Tympanic Membrane |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set: all enrolled and treated subjects |
| Arm/Group Title | 6 mg OTO-201 |
|---|---|
| Arm/Group Description | 6 mg ciprofloxacin: single Trans-Tympanic Tube Administration |
| Measure Participants | 33 |
| Measure ears | 66 |
| Count of Units [ears] |
2
|
| Title | Otoscopic Examination: Tube Patency |
|---|---|
| Description | Subjects with at least one ear tube patent (i.e., not blocked) at Day 29 |
| Time Frame | Up to 1 month |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set: all enrolled and treated subjects |
| Arm/Group Title | 6 mg OTO-201 |
|---|---|
| Arm/Group Description | 6 mg ciprofloxacin: single Trans-Tympanic Tube Administration |
| Measure Participants | 33 |
| Count of Participants [Participants] |
32
97%
|
| Title | Feasibility of Administration |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set consisted of all enrolled and treated subjects |
| Arm/Group Title | 6 mg OTO-201 |
|---|---|
| Arm/Group Description | 6 mg ciprofloxacin: single Trans-Tympanic Tube Admin istration |
| Measure Participants | 33 |
| Count of Participants [Participants] |
29
87.9%
|
Adverse Events
| Time Frame | Adverse events were reported during dosing and up to 1 month following dosing. | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | 6 mg OTO-201 | |
| Arm/Group Description | 6 mg ciprofloxacin: single Trans-Tympanic Tube Administration | |
All Cause Mortality |
||
| 6 mg OTO-201 | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/33 (0%) | |
Serious Adverse Events |
||
| 6 mg OTO-201 | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/33 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| 6 mg OTO-201 | ||
| Affected / at Risk (%) | # Events | |
| Total | 20/33 (60.6%) | |
| Ear and labyrinth disorders | ||
| Ear Pain | 4/33 (12.1%) | |
| General disorders | ||
| Pyrexia | 4/33 (12.1%) | |
| Infections and infestations | ||
| Nasopharyngitis | 7/33 (21.2%) | |
| Upper Respiratory Infection | 3/33 (9.1%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Nasal Congestion | 2/33 (6.1%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Publication subject to Sponsor consent.
Results Point of Contact
| Name/Title | Medical Information Call Center |
|---|---|
| Organization | Otonomy, Inc. |
| Phone | 1-800-826-6411 |
| medinfo@otonomy.com |
- 201-201404