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

The purpose of this study is to determine if an otic formulation is safe and effective for the treatment of acute otitis externa (AOE).

Study Overview

• Status: Completed
• Conditions: Acute Otitis Externa
• Intervention / Treatment: Drug: Moxidex otic solution; Device: Tympanostomy tubes; Drug: Moxifloxacin otic solution; Drug: Dexamethasone phosphate otic solution

• Study Type: Interventional
• Enrollment (Actual): 990
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moxidex; Moxidex otic solution	Drug: Moxidex 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
Active Comparator: Moxifloxacin; Moxifloxacin otic solution	Device: Tympanostomy tubes; Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media with effusion in children; Drug: Moxifloxacin otic solution; 4 drops in the infected ear(s) twice daily (morning and evening) for 7 days
Active Comparator: Dexamethasone; Dexamethasone phosphate otic solution	Device: Tympanostomy tubes; Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media with effusion in children; Drug: Dexamethasone phosphate otic solution; 4 drops in the infected ear(s) twice daily (morning and evening) for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical Cure	Day 3
Clinical Cure	Day 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Microbiological Success	Day 12

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Contact Alcon Call Center, 1-888-451-3937

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: September 8, 2008
• First Submitted That Met QC Criteria: September 9, 2008
• First Posted (Estimate): September 10, 2008

Study Record Updates

• Last Update Posted (Estimate): December 3, 2012
• Last Update Submitted That Met QC Criteria: November 29, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: ear infection; swimmer's ear; ear drops; ear pain; ear inflammation
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis Externa; Otitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Dexamethasone; Moxifloxacin; Pharmaceutical Solutions; Dexamethasone 21-phosphate
• Other Study ID Numbers: C-07-13