Phase 3
Completed N=266
OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
Otitis Media With Effusion
Source: ClinicalTrials.gov NCT01949155 ↗
Enrolled (actual)
266
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcomePrimary: Percentage of Participants Who Were Treatment Failures. — 21.3; 45.5 percentage of treatment failures
◆ Published Evidence
Established
20citations · ~2 / year
Safety and Efficacy of Intratympanic Ciprofloxacin Otic Suspension in Children With Middle Ear Effusion Undergoing Tympanostomy Tube Placement: Two Randomized Clinical Trials.
Summary
The purpose of this study is to confirm the effectiveness, safety and tolerability of OTO-201 in the treatment of pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.
Linked Publications
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Safety and Efficacy of Intratympanic Ciprofloxacin Otic Suspension in Children With Middle Ear Effusion Undergoing Tympanostomy Tube Placement: Two Randomized Clinical Trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Were Treatment Failures. |
21.3; 45.5 | — |
| SECONDARY Evaluation of Adverse Events, Otoscopic Exams, Audiometry and Tympanometry |
1.7; 2.4; 1.7; 3.5; 96.0; 100 | — |
| SECONDARY Microbiological Response |
83; 48 | — |
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 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 tympanostomy tube placement
- Subject has a history of sensorineural hearing loss
- Subject has a history of chronic or recurrent bacterial infections other than otitis media that likely will require treatment with antibiotics during the course of the study
Data sourced from ClinicalTrials.gov (NCT01949155) and the linked publication. 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. Informational only — not medical advice.