A Phase III Study of an Otic Formulation in Acute Otitis Externa

Acute Otitis Externa Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00750633
• Other study ID #: C-07-13
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2008
• Last updated: November 29, 2012
• Start date: June 2008
• 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 for the treatment of acute otitis externa (AOE).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 990
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Acute Otitis Externa
• Otitis
• Otitis Externa

Intervention

Drug:
• Moxidex otic solution
4 drops in the infected ear(s) twice daily (morning and evening) for 7 days
• Moxifloxacin otic solution
4 drops in the infected ear(s) twice daily (morning and evening) for 7 days
• Dexamethasone phosphate otic solution
4 drops in 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 with effusion 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		Day 3	No
Primary	Clinical Cure		Day 12	No
Secondary	Microbiological Success		Day 12	No