CompletedPhase 3

Phase III Study of an Otic Formulation in Acute Otitis Media With Tympanostomy Tubes

776 participantsStarted 2006-01

Plain-language summary

The purpose of this study is to determine if a topical otic formulation is safe and effective in treating middle ear infections in patients with ear tubes.

Who can participate

Age range

6 Months – 12 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: * 6 months to 12 years old * Ear tubes in one or both ears * Ear drainage visible by the parent / guardian * Ear drainage less than 21 days * Ear tube may not be silver oxide, silver salt, t-type tube or long-shafted tube * Patient may not have non-tube otorrhea * Patient may not have had otic surgery other than tube placement in the last year * Patient may not be a menarchal female * Diabetic patients are not eligible * Patient may not have any disease or condition that would negatively affect the conduct of the study * Patient may not require any other systemic antimicrobial therapy during the study. * Patient must meet certain medication washouts to be eligible * Analgesic use (other than acetaminophen) is not allowed * Patient may not be pre-disposed to neurosensory hearing loss * Other protocol-defined inclusion criteria may apply Exclusion Criteria: * Age * Other protocol-defined exclusion criteria may apply

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.

What they're measuring

Time to cessation of otorrhea as recorded by the parent or guardian via a patient diary

Timeframe: From baseline

Trial details

NCT IDNCT00579189

SponsorAlcon Research

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-01

View on ClinicalTrials.gov More Acute Otitis Media trials

Who can participate

Age range

6 Months – 12 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.