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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Email Otonomy Central Contact for Trial Locations
San Diego, California, United States
Otoscopic Examination: Tympanic Membrane
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)
Time frame: Up to 1 month
Otoscopic Examination: Middle Ear
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)
Time frame: Up to 1 month
Feasibility of Administration
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".
Time frame: Day1
Overall Adverse Events
Number of Subjects with and without adverse events during the study from dosing up to 1 month after dosing
Time frame: up to 1 month
Number of Subjects Considered a Clinical Cure at Day 15 (Intent-to-treat Analysis Set)
Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows: None = 0 Mild = 1 Moderate = 2 Severe = 3
Time frame: Day 15 (two weeks from dosing)
Number of Subjects Considered a Clinical Cure at Day 15 (Per-protocol Analysis Set)
Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows: None = 0 Mild = 1 Moderate = 2 Severe = 3
Time frame: Day 15 (2 weeks from dosing)
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