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

NCT00578474 | Completed Phase 3

• 1 other identifier: C-05-35
• Study Type: interventional
• Target: 911
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Acute Otitis Media

Keywords

Acute otitis media; Tympanostomy tubes

Outcome Measures

Primary Outcomes (1)

• Clinical cure rate at the test of cure visit as determined by the investigator

  From baseline

Secondary Outcomes (3)

• Time to cessation of otorrhea

  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

FLOXIN

ACTIVE COMPARATOR

Ofloxacin otic solution

Drug: Ofloxacin 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

Ofloxacin otic solution DRUG

5 drops into the infected ear(s) twice daily (morning and evening) for 10 days

Also known as: FLOXIN

FLOXIN

Tympanostomy tubes DEVICE

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

FLOXIN; Moxidex

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 related

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Otitis Media

Interventions

Ofloxacin

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

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: December 1, 2005
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: December 3, 2012

Record last verified: 2012-11