Phase 3
N=262
Phase 3 Study of OTO-201 in Acute Otitis Externa
Acute Otitis Externa · Swimmer's Ear
Bottom Line
View on ClinicalTrials.gov: NCT02801370 ↗Enrolled (actual)
262
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Number of Subjects Considered a Clinical Cure at Day 8 — 91; 63 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 12 mg ciprofloxacin (Drug); Sham Control (Drug)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Otonomy, Inc.
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Considered a Clinical Cure at Day 8 |
91; 63 | — |
| SECONDARY Number of Subjects Considered a Clinical Cure at Day 15 |
97; 69 | — |
Summary
This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study in which eligible subjects with acute otitis externa (AOE) will be randomized to receive a single administration of either 12 mg OTO-201 or Sham-Control (empty syringe) to the external auditory canal of the affected ear(s).
Eligibility Criteria
Inclusion Criteria includes, but is not limited to:
- Subject is a male or female age 6 months or older
- Subject has a clinical diagnosis of unilateral or bilateral acute otitis externa
- Subject or 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 tympanic membrane perforation
- Subject has eczematoid otitis externa
- Subject has diabetes mellitus
Data sourced from ClinicalTrials.gov (NCT02801370). 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.