Phase 3
Completed N=262
Phase 3 Study of OTO-201 in Acute Otitis Externa
Acute Otitis Externa · Swimmer's Ear
Source: ClinicalTrials.gov NCT02801370 ↗
Enrolled (actual)
262
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Number of Subjects Considered a Clinical Cure at Day 8 — 91; 63 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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).
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 | — |
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. Informational only — not medical advice.