OTO-201 for the Treatment of Otitis Externa (NCT02511561) | Clinical Trial Compass
CompletedPhase 2
OTO-201 for the Treatment of Otitis Externa
United States75 participantsStarted 2015-07
Plain-language 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.
Who can participate
Age range
6 Months – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.