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

Acute Otitis Media Clinical Trial

Official title:

Safety and Efficacy of a Topical Otic Formulation in the Treatment of Acute Otitis Media With Otorrhea Through Tympanostomy Tubes (AOMT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00579189
• Other study ID #: C-05-36
• Status: Completed
• Phase: Phase 3
• First received: December 19, 2007
• Last updated: November 29, 2012
• Start date: January 2006
• Est. completion date: January 2009

Study information

• Verified date: November 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 776
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Otitis Media
• Otitis
• Otitis Media

Intervention

Drug:
• Moxidex otic solution
4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
• Moxifloxacin otic solution
4 drops into the infected ear(s) twice daily (morning and evening) for 7 days

Device:
• Tympanostomy tubes
Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to cessation of otorrhea as recorded by the parent or guardian via a patient diary		From baseline	No
Secondary	Clinical cure rate		From baseline	No
Secondary	Microbiological outcome		From baseline	No
Secondary	Treatment failures		From baseline	No