A Phase III Study of an Otic Formulation in Acute Otitis Externa - Full Text View

Purpose

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

Condition	Intervention	Phase
Acute Otitis Externa	Drug: Moxidex otic solution Drug: Moxifloxacin otic solution Drug: Dexamethasone phosphate otic solution Device: Tympanostomy tubes	Phase 3

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

Resource links provided by NLM:

Drug Information available for: Dexamethasone Dexamethasone phosphate Dexamethasone acetate Dexamethasone sodium phosphate Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Clinical Cure [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
Clinical Cure [ Time Frame: Day 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Microbiological Success [ Time Frame: Day 12 ] [ Designated as safety issue: No ]

Enrollment:	990
Study Start Date:	June 2008
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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	Drug: Moxifloxacin 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: Dexamethasone Dexamethasone phosphate otic solution	Drug: 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

Eligibility

Ages Eligible for Study:	6 Months and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750633

Sponsors and Collaborators

Alcon Research

Investigators

Study Director:

Contact Alcon Call Center

1-888-451-3937

More Information

No publications provided

Responsible Party:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00750633 History of Changes
Other Study ID Numbers:	C-07-13
Study First Received:	September 8, 2008
Last Updated:	November 29, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alcon Research:

swimmer's ear
ear drops
ear infection
ear pain
ear inflammation

Additional relevant MeSH terms:

Otitis Externa
Otitis
Ear Diseases
Otorhinolaryngologic Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents
Contraceptives, Oral, Combined
Contraceptives, Oral

ClinicalTrials.gov processed this record on May 21, 2013