A 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: NCT00578474
• Other study ID #: C-05-35
• Status: Completed
• Phase: Phase 3
• First received: December 19, 2007
• Last updated: November 29, 2012
• Start date: December 2005
• Est. completion date: August 2008

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 an otic formulation is safe and effective in treating middle ear infections in patients with ear tubes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 911
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• 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 related

• 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
• Ofloxacin otic solution
5 drops into the infected ear(s) twice daily (morning and evening) for 10 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	Clinical cure rate at the test of cure visit as determined by the investigator		From baseline	No
Secondary	Time to cessation of otorrhea		From baseline	No
Secondary	Microbiological outcome		From baseline	No
Secondary	Treatment failures		From baseline	No