Safety and Efficacy of Moxidex Otic

Acute Otitis Media Clinical Trial

Official title:

Safety and Efficacy Evaluation of Topical Moxidex Otic Solution in the Treatment of Acute Otitis Media With Otorrhea in Tympanostomy Tubes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01071902
• Other study ID #: C-09-033
• Status: Terminated
• Phase: Phase 3
• First received: February 18, 2010
• Last updated: November 29, 2012
• Start date: February 2010
• Est. completion date: October 2011

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 Moxidex otic solution is safe and effective in treating middle ear infections in patients with ear tubes.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 400
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 12 Years

Eligibility

Inclusion Criteria:

• 6 months to 12 years of age

• Ear tubes in one or both ears

• Ear drainage visible by parent/guardian

• Ear drainage less than 21 days

• Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

• Patients not otorrhea-free for 7 or less following tympanostomy tube surgery

• Ear tube with antimicrobial activity; ear tube longer than 2.5mm

• Non-tube otorrhea

• No otic surgery other than tube placement in the last year

• No menarchial females; no diabetic patients

• No patients with any disease or condition that would negatively affect the conduct of the study

• No patients taking 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

• Patients may not be predisposed to neurosensory hearing loss

• Other protocol-defined exclusion criteria may apply

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), 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

Other:
• Vehicle
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
United States	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Cure at End of Treatment		Day 8	No
Secondary	Time to Cessation of Otorrhea		From First Dose	No
Secondary	Microbiological Success at End of Treatment		Day 8	No