Overview

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

Status:
Completed
Trial end date:
2008-08-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine if an otic formulation is safe and effective in treating middle ear infections in patients with ear tubes.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Alcon Research
Treatments:
Levofloxacin
Ofloxacin
Pharmaceutical Solutions
Criteria
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 related

- Other protocol-defined exclusion criteria may apply