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

Primary Purpose

Acute Otitis Media

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Moxidex otic solution

Ofloxacin otic solution

Tympanostomy tubes

About this trial

This is an interventional treatment trial for Acute Otitis Media focused on measuring Acute otitis media, Tympanostomy tubes

Eligibility Criteria

6 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Moxidex

FLOXIN

Arm Description

Moxidex otic solution

Ofloxacin otic solution

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to cessation of otorrhea

Microbiological outcome

Treatment failures

Full Information

NCT ID

NCT00578474

First Posted

December 19, 2007

Last Updated

November 29, 2012

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT00578474

Brief Title

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

Official Title

Safety and Efficacy of a Topical Otic Formulation in the Treatment of Acute Otitis Media With Otorrhea Through Tympanostomy Tubes (AOMT)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Completed

Study Start Date

December 2005 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alcon Research

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Otitis Media

Keywords

Acute otitis media, Tympanostomy tubes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

911 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Moxidex

Arm Type

Experimental

Arm Description

Moxidex otic solution

Arm Title

FLOXIN

Arm Type

Active Comparator

Arm Description

Ofloxacin otic solution

Intervention Type

Drug

Intervention Name(s)

Moxidex otic solution

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Ofloxacin otic solution

Other Intervention Name(s)

FLOXIN

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Tympanostomy tubes

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

From baseline

Secondary Outcome Measure Information:

Title

Time to cessation of otorrhea

Time Frame

From baseline

Title

Microbiological outcome

Time Frame

From baseline

Title

Treatment failures

Time Frame

From baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Contact Alcon Call Center

Organizational Affiliation

1-888-451-3937

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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