A 1-Month, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Administration for Treatment of Otitis Externa
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Otonomy, Inc.
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Otoscopic Examination: Tympanic Membrane
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Months to 80 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
0.1 mL OTO-201
Ciprofloxacin
Intervention: OTO-201 (ciprofloxacin) (Drug)
0.2 mL OTO-201
Ciprofloxacin
Intervention: OTO-201 (ciprofloxacin) (Drug)
0.4 mL OTO-201
Ciprofloxacin
Intervention: OTO-201 (ciprofloxacin) (Drug)
Outcomes
Primary Outcomes
Otoscopic Examination: Tympanic Membrane
Time Frame: Up to 1 month
Number of subjects with a tympanic membrane that was rated as "Not able to Visualize" or "Abnormal" at Baseline that was rated as "Normal" at Day 29 (final study day)
Otoscopic Examination: Middle Ear
Time Frame: Up to 1 month
Number of subjects with a middle ear that was rated as "Not Able to Visualize" or "Abnormal" at Baseline that had a middle ear rated as "Normal" at Day 29 (final study visit)
Feasibility of Administration
Time Frame: Day1
Ease of administering OTO-201 to the external ear canal. Number of subjects that investigators rated ease of administration as either "easy" or "very easy".
Overall Adverse Events
Time Frame: up to 1 month
Number of Subjects with and without adverse events during the study from dosing up to 1 month after dosing
Secondary Outcomes
- Number of Subjects Considered a Clinical Cure at Day 15 (Intent-to-treat Analysis Set)(Day 15 (two weeks from dosing))
- Number of Subjects Considered a Clinical Cure at Day 15 (Per-protocol Analysis Set)(Day 15 (2 weeks from dosing))