Phase 3
N=33
Open-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration
Bilateral Middle Ear Effusion
Bottom Line
View on ClinicalTrials.gov: NCT02350998 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Otoscopic Examination: Auricle and Meatus — 1 ears
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- OTO-201 (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Otonomy, Inc.
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Otoscopic Examination: Auricle and Meatus |
1 | — |
| PRIMARY Otoscopic Examination: Tympanic Membrane |
2 | — |
| PRIMARY Otoscopic Examination: Tube Patency |
32 | — |
| SECONDARY Feasibility of Administration |
29 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02350998). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.