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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01908803
Recruitment Status : Terminated (Management decision)
First Posted : July 26, 2013
Results First Posted : September 24, 2015
Last Update Posted : December 6, 2017
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study is to evaluate a single application of AL-60371/AL-817 Otic Suspension relative to ototopical CIPRODEX for sustained clinical cure, microbiological success, and time to cessation of otorrhea.

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
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)
Study Start Date : December 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01908803

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

Responsible Party: Alcon Research Identifier: NCT01908803     History of Changes
Other Study ID Numbers: C-13-026
First Posted: July 26, 2013    Key Record Dates
Results First Posted: September 24, 2015
Last Update Posted: December 6, 2017
Last Verified: November 2017

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