A Phase II Study of an Otic Formulation in Treating Peri-Operative Tube Otorrhea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00578773
First received: December 19, 2007
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 in treating peri-operative tube otorrhea.


Condition Intervention Phase
Acute Otitis Media
Drug: Moxidex otic solution
Drug: Moxifloxacin otic solution
Device: Tympanostomy tubes
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of a Topical Otic Formulation in the Treatment of Peri-Operative Tube Otorrhea

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Time to cessation of otorrhea as recorded by the parent or guardian via a patient diary [ Time Frame: From baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical cures at each visit [ Time Frame: From baseline ] [ Designated as safety issue: No ]
  • Absence of otorrhea at each visit [ Time Frame: From baseline ] [ Designated as safety issue: No ]

Enrollment: 303
Study Start Date: November 2007
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 into 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 in children
Active Comparator: Moxifloxacin
Moxifloxacin otic solution
Drug: Moxifloxacin otic solution
4 drops into 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 in children
TT only
Tympanostomy tubes only
Device: Tympanostomy tubes
Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children

  Eligibility

Ages Eligible for Study:   6 Months to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 6 months to 12 years old
  • Diagnosed with recurrent acute otitis media or chronic otitis media with effusion
  • Must be first set of ear tubes.
  • Patient may not have had any other previous otologic-related surgery.
  • Ear tube may not be silver oxide, silver salt, t-type tube or long-shafted tube
  • Patient may not have existing perforation of the eardrum.
  • Patient must not require another surgical procedure other than myringotomy and tube insertion.
  • Patient may not be a menarchal female
  • Diabetic patients are not eligible
  • Patient may not have any disease or condition that would negatively affect the conduct of the study
  • Patient may not require any other systemic antimicrobial therapy during the study.
  • Patient must meet certain medication washouts to be eligible
  • Analgesic use (other than acetaminophen) is not allowed
  • Patient may not be pre-disposed to neurosensory hearing loss
  • Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

  • Age
  • 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: NCT00578773

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: NCT00578773     History of Changes
Other Study ID Numbers: C-05-38
Study First Received: December 19, 2007
Last Updated: November 29, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
ear tubes
ear infection
ear drops
ear tube surgery
acute otitis media

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Pharmaceutical Solutions
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 20, 2014