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

NCT00579189 | Completed Phase 3

• 1 other identifier: C-05-36
• Study Type: interventional
• Target: 776
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Acute Otitis Media

Keywords

ear tubes; ear drainage; ear infection; ear drops

Outcome Measures

Primary Outcomes (1)

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

  From baseline

Secondary Outcomes (3)

• Clinical cure rate

  From baseline

• Microbiological outcome

  From baseline

• Treatment failures

  From baseline

Study Arms (2)

Moxidex

EXPERIMENTAL

Moxidex otic solution

Drug: Moxidex otic solution; Device: Tympanostomy tubes

Moxifloxacin

ACTIVE COMPARATOR

Moxifloxacin otic solution

Drug: Moxifloxacin otic solution; Device: Tympanostomy tubes

Interventions

Moxidex otic solution DRUG

4 drops into the infected ear(s) twice daily (morning and evening) for 7 days

Moxidex

Moxifloxacin otic solution DRUG

4 drops into the infected ear(s) twice daily (morning and evening) for 7 days

Moxifloxacin

Tympanostomy tubes DEVICE

Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children

Moxidex; Moxifloxacin

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Age

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Otitis Media; Otitis

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Contact Alcon Call Center

  1-888-451-3937

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 21, 2007
• Study Start: January 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: December 3, 2012

Record last verified: 2012-11