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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00578773
Other study ID # C-05-38
Secondary ID
Status Completed
Phase Phase 2
First received December 19, 2007
Last updated November 29, 2012
Start date November 2007
Est. completion date January 2009

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 peri-operative tube otorrhea.


Recruitment information / eligibility

Status Completed
Enrollment 303
Est. completion date January 2009
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender Both
Age group 6 Months to 12 Years
Eligibility Inclusion Criteria:

- 6 months to 12 years old

- Diagnosed with recurrent acute otitis media or chronic otitis media with effusion

- Must be first set of ear tubes.

- Patient may not have had any other previous otologic-related surgery.

- Ear tube may not be silver oxide, silver salt, t-type tube or long-shafted tube

- Patient may not have existing perforation of the eardrum.

- Patient must not require another surgical procedure other than myringotomy and tube insertion.

- 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

- Other protocol-defined exclusion criteria may apply

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), 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
Moxifloxacin otic solution
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
n/a

Sponsors (1)

Lead Sponsor Collaborator
Alcon Research

Outcome

Type Measure Description Time frame Safety issue
Primary Time to cessation of otorrhea as recorded by the parent or guardian via a patient diary From baseline No
Secondary Clinical cures at each visit From baseline No
Secondary Absence of otorrhea at each visit From baseline No
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