Proof-of-Concept Study of a Single Application of an Investigational Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Alcon Research
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01908803
First received: July 24, 2013
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to evaluate a single application of AL-60371/AL-817 Otic Suspension relative to ototopical CIPRODEX for microbiological success at Day 8 and time to cessation of otorrhea.


Condition Intervention Phase
Acute Otitis Media
Drug: AL-60371/AL-817 otic suspension
Drug: Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Proportion of subjects with sustained clinical cure at Day 3 visit [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    A sustained clinical cure at Day 3 will be attained if otorrhea is absent at the Day 3 visit and continues to be absent through the last study visit (Day 8 or Early Exit).


Secondary Outcome Measures:
  • Proportion of subjects with microbiological success at the Day 8 visit [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
    Microbiological success will be attained if all pre-therapy bacteria are absent in the Day 8 specimen. If no otorrhea at Day 8, eradication of pre-therapy bacteria will be presumed and the subject will be considered a microbiological success.

  • Time (in days) to cessation of otorrhea [ Time Frame: Time to event, up to Day 8 ] [ Designated as safety issue: No ]
    The time (in days) to the cessation of otorrhea (ie, otorrhea is absent) will be calculated as the number of days from the Day 1 (Visit 1) to the absence of otorrhea in the study ear as recorded by the parent/guardian via the twice-daily diary. Cessation of otorrhea will be defined as ending on the first day that otorrhea is absent from the study ear and remains absent for any/all subsequent diary entries.


Estimated Enrollment: 140
Study Start Date: December 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AL-60371/AL-817
AL-60371/AL-817 otic suspension, 1 drop in study ear through tympanostomy tube on Day 1 (Visit 1)
Drug: AL-60371/AL-817 otic suspension
Active Comparator: CIPRODEX
Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension, 4 drops in study ear twice daily through tympanostomy tube for 7 days
Drug: Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension
CIPRODEX®

  Eligibility

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

Inclusion Criteria:

  • Parent or guardian: Read and sign the informed consent. When required by the Institutional Review Board, child must agree to sign an approved assent form;
  • Presence of otorrhea (visible by parent or guardian) of 21 days or less in duration;
  • Presence of patent tympanostomy tubes;
  • Refrain from water immersion of the ears following surgery without the use of adequate ear protection during swimming, bathing, showering and other water-related activities;
  • Parent or guardian: Agree to comply with the requirements of the study, administer the study medication as directed, complete required study visits, and comply with the protocol;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • NOT otorrhea-free for at least seven days following tympanostomy tube surgery;
  • Menarcheal females;
  • Previous otologic surgery, except tympanic membrane, within one year of study entry;
  • History of/or current acute or chronic non-tube otorrhea (through existing perforation of the eardrum);
  • Current acute otitis externa, malignant otitis externa, or other conditions which could interfere with evaluation of the study drug;
  • Diabetic (controlled or uncontrolled);
  • Use of prohibited medications;
  • 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: NCT01908803

Contacts
Contact: Alcon Call Center 1-888-451-3937 alcon.medinfo@alcon.com

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations Recruiting
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Celeste McLean, BS, MT (ASCP) Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01908803     History of Changes
Other Study ID Numbers: C-13-026
Study First Received: July 24, 2013
Last Updated: April 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
AOMT
tympanostomy tubes
Otorrhea
anti-infective

Additional relevant MeSH terms:
Otitis Media
Otitis
Ear Diseases
Otorhinolaryngologic Diseases
Ciprofloxacin
BB 1101
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Anti-Inflammatory Agents
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

ClinicalTrials.gov processed this record on July 10, 2014