Phase 2
N=75
OTO-201 for the Treatment of Otitis Externa
Otitis Externa
Bottom Line
View on ClinicalTrials.gov: NCT02511561 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Otoscopic Examination: Tympanic Membrane — 6; 8; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- OTO-201 (ciprofloxacin) (Drug)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Otonomy, Inc.
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Otoscopic Examination: Tympanic Membrane |
6; 8; 8 | — |
| PRIMARY Otoscopic Examination: Middle Ear |
8; 7; 8 | — |
| PRIMARY Feasibility of Administration |
24; 25; 25 | — |
| PRIMARY Overall Adverse Events |
8; 9; 13; 17; 16; 12 | — |
| SECONDARY Number of Subjects Considered a Clinical Cure at Day 15 (Intent-to-treat Analysis Set) |
14; 19; 16 | — |
| SECONDARY Number of Subjects Considered a Clinical Cure at Day 15 (Per-protocol Analysis Set) |
13; 19; 15 | — |
Summary
This is a 1-month, multicenter, open-label study in subjects with unilateral otitis externa. Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear. The study is designed to characterize safety, procedural factors and clinical effect of OTO-201 administered in subjects with otitis externa.
Eligibility Criteria
Inclusion Criteria includes, but is not limited to:
- Subject is a male or female aged 6 months to 80 years, inclusive
- Subject has a clinical diagnosis of unilateral 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 a history of known immunodeficiency disease
- Subject has fungal otitis externa, based on clinical signs
Data sourced from ClinicalTrials.gov (NCT02511561). 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.