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

This study has been terminated.
(Management decision)
Information provided by (Responsible Party):
Alcon Research Identifier:
First received: July 24, 2013
Last updated: October 16, 2015
Last verified: October 2015
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
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Proof of Concept of Single Application of AL-60371/AL-817 Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes Compared to CIPRODEX® (BID for 7 Days)

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 post-treatment up to Day 8 or Early Exit ]
    A sustained clinical cure at Day 3 was attained if otorrhea was absent at the Day 3 visit and continued to be absent through the last study visit (Day 8 or Early Exit). Proportion of subjects is reported as a percentage.

Secondary Outcome Measures:
  • Proportion of Subjects With Microbiological Success at the Day 8 Visit [ Time Frame: Day 8 ]
    Microbiological success was attained if all pre-therapy bacteria were absent in the Day 8 specimen. In a subject with no otorrhea at Day 8, eradication of pre-therapy bacteria was presumed and the subject was considered a microbiological success.

  • Median Time (in Days) to Cessation of Otorrhea [ Time Frame: Time to event, up to Day 8 ]
    Median time (in days) to the cessation of otorrhea (ie, otorrhea was absent) was calculated as the number of days from the Day 1 (Visit 1) to the absence of otorrhea in the affected ear(s) as recorded by the parent/guardian via the twice-daily diary. Cessation of otorrhea was defined as ending on the first day that otorrhea was absent from the affected ear(s) and remained absent for any/all subsequent diary entries.

Enrollment: 84
Study Start Date: December 2013
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AL-60371/AL-817
AL-60371/AL-817 otic suspension, 200 μL in affected ear(s) 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 affected ear(s) twice daily through tympanostomy tube for 7 days
Drug: Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension

Detailed Description:
The results at the time of the interim analysis met the futility criteria and the study was subsequently stopped.

Ages Eligible for Study:   6 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01908803

Sponsors and Collaborators
Alcon Research
Study Director: Clinical Manager, GCRA, Pharma Alcon Research
  More Information

Responsible Party: Alcon Research Identifier: NCT01908803     History of Changes
Other Study ID Numbers: C-13-026
Study First Received: July 24, 2013
Results First Received: August 24, 2015
Last Updated: October 16, 2015

Keywords provided by Alcon Research:
tympanostomy tubes

Additional relevant MeSH terms:
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors processed this record on September 21, 2017