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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00578474
Other study ID # C-05-35
Secondary ID
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


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
See also
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