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

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; 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

• Other protocol-defined exclusion criteria may apply