Bilateral Middle Ear Effusion Clinical Trial
Official title:
A 1-Month, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Trans-Tympanic Tube Administration for Intra-Operative Treatment of Middle Ear Effusion in Pediatric Subjects With Otitis Media Requiring Tympanostomy Tube Placement
| NCT number | NCT02350998 |
| Other study ID # | 201-201404 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | January 2015 |
| Est. completion date | March 2015 |
| Verified date | September 2020 |
| Source | Otonomy, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 33 |
| Est. completion date | March 2015 |
| Est. primary completion date | March 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 6 Months to 17 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Charlotte Eye, Ear, Nose and Throat Associates | Charlotte | North Carolina |
| United States | Central California Ear, Nose and Throat | Fresno | California |
| United States | Charlotte Eye, Ear, Nose and Throat Associates | Matthews | North Carolina |
| United States | Carolina Ear, Nose and Throat | Orangeburg | South Carolina |
| United States | Piedmont Ear, Nose and Throat | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Otonomy, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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 | Up to 1 month | |
| 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 | up to 1 month | |
| Primary | Otoscopic Examination: Tube Patency | Subjects with at least one ear tube patent (i.e., not blocked) at Day 29 | Up to 1 month | |
| 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" | Day 1 |