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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00750633
First received: September 8, 2008
Last updated: November 29, 2012
Last verified: November 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Otitis Externa
Ear Diseases
Otorhinolaryngologic Diseases
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Pharmaceutical Solutions
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Combined
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on October 20, 2014