A Phase III Study of an Otic Formulation in Acute Otitis Externa
Primary Purpose
Acute Otitis Externa
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Moxidex otic solution
Moxifloxacin otic solution
Dexamethasone phosphate otic solution
Tympanostomy tubes
Sponsored by
About this trial
This is an interventional treatment trial for Acute Otitis Externa focused on measuring swimmer's ear, ear drops, ear infection, ear pain, ear inflammation
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of AOE based on clinical observation and of presumed bacterial origin
- A minimum combined score of ≥4 in at least 1 affected ear at the Day 1 exam for tenderness, erythema, and edema
- Other protocol-defined inclusion criteria may apply
Exclusion Criteria:
- Duration of pretherapy signs or symptoms of AOE greater than four (4) weeks
- Presence of a tympanostomy tube or perforated tympanic membrane in the treated ear(s). Patients with a history of tympanic membrane perforation should not be enrolled unless the absence of a current perforation can be confirmed at Visit 1 prior to enrollment
- Clinically diagnosed chronic suppurative otitis media, acute otitis media, acute otorrhea in patients with tympanostomy tubes, or malignant otitis externa
- Known or suspected ear infection of fungal or mycobacterial origin
- Prior otologic surgery within 6 months of study entry
- Seborrheic dermatitis or other skin conditions of the external auditory canal
- Current or prior history of an immunosuppressive disorder (e.g., HIV positive) or current immunosuppressive therapy (e.g., cancer chemotherapy) or known acute or chronic renal disorders or active hepatitis
- Diabetic patients (controlled or uncontrolled) based upon assessment by Investigator
- Any systemic disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study [e.g., cleft palate (including repairs), Downs Syndrome, and cranial facial reconstruction]
- Any current known or suspected infection (other than AOE) requiring systemic antimicrobial therapy
- Use of prohibited medications or inadequate washout of any medication listed in protocol
- Concomitant use of topical or oral analgesics (i.e., NSAIDs and aspirin products) which may have anti inflammatory effects. Patients on low dose aspirin therapy (81 mg per day) at the time of enrollment may be enrolled and continue the low dose aspirin during the study. Use of acetaminophen ("Tylenol") is permitted during the trial
- Other protocol-defined exclusion criteria may apply
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Moxidex
Moxifloxacin
Dexamethasone
Arm Description
Moxidex otic solution
Moxifloxacin otic solution
Dexamethasone phosphate otic solution
Outcomes
Primary Outcome Measures
Clinical Cure
Clinical Cure
Secondary Outcome Measures
Microbiological Success
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00750633
Brief Title
A Phase III Study of an Otic Formulation in Acute Otitis Externa
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine if an otic formulation is safe and effective for the treatment of acute otitis externa (AOE).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Otitis Externa
Keywords
swimmer's ear, ear drops, ear infection, ear pain, ear inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
990 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Moxidex
Arm Type
Experimental
Arm Description
Moxidex otic solution
Arm Title
Moxifloxacin
Arm Type
Active Comparator
Arm Description
Moxifloxacin otic solution
Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Description
Dexamethasone phosphate otic solution
Intervention Type
Drug
Intervention Name(s)
Moxidex otic solution
Intervention Description
4 drops in the infected ear(s) twice daily (morning and evening) for 7 days
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin otic solution
Intervention Description
4 drops in the infected ear(s) twice daily (morning and evening) for 7 days
Intervention Type
Drug
Intervention Name(s)
Dexamethasone phosphate otic solution
Intervention Description
4 drops in the infected ear(s) twice daily (morning and evening) for 7 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 with effusion in children
Primary Outcome Measure Information:
Title
Clinical Cure
Time Frame
Day 3
Title
Clinical Cure
Time Frame
Day 12
Secondary Outcome Measure Information:
Title
Microbiological Success
Time Frame
Day 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of AOE based on clinical observation and of presumed bacterial origin
A minimum combined score of ≥4 in at least 1 affected ear at the Day 1 exam for tenderness, erythema, and edema
Other protocol-defined inclusion criteria may apply
Exclusion Criteria:
Duration of pretherapy signs or symptoms of AOE greater than four (4) weeks
Presence of a tympanostomy tube or perforated tympanic membrane in the treated ear(s). Patients with a history of tympanic membrane perforation should not be enrolled unless the absence of a current perforation can be confirmed at Visit 1 prior to enrollment
Clinically diagnosed chronic suppurative otitis media, acute otitis media, acute otorrhea in patients with tympanostomy tubes, or malignant otitis externa
Known or suspected ear infection of fungal or mycobacterial origin
Prior otologic surgery within 6 months of study entry
Seborrheic dermatitis or other skin conditions of the external auditory canal
Current or prior history of an immunosuppressive disorder (e.g., HIV positive) or current immunosuppressive therapy (e.g., cancer chemotherapy) or known acute or chronic renal disorders or active hepatitis
Diabetic patients (controlled or uncontrolled) based upon assessment by Investigator
Any systemic disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study [e.g., cleft palate (including repairs), Downs Syndrome, and cranial facial reconstruction]
Any current known or suspected infection (other than AOE) requiring systemic antimicrobial therapy
Use of prohibited medications or inadequate washout of any medication listed in protocol
Concomitant use of topical or oral analgesics (i.e., NSAIDs and aspirin products) which may have anti inflammatory effects. Patients on low dose aspirin therapy (81 mg per day) at the time of enrollment may be enrolled and continue the low dose aspirin during the study. Use of acetaminophen ("Tylenol") is permitted during the trial
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 Externa
We'll reach out to this number within 24 hrs