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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

Primary Purpose

Acute Otitis Media

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
AL-60371/AL-817 otic suspension
Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Otitis Media focused on measuring AOMT, tympanostomy tubes, Otorrhea, anti-infective

Eligibility Criteria

6 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    AL-60371/AL-817

    CIPRODEX

    Arm Description

    AL-60371/AL-817 otic suspension, 200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)

    Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension, 4 drops in affected ear(s) twice daily through tympanostomy tube for 7 days

    Outcomes

    Primary Outcome Measures

    Proportion of Subjects With Sustained Clinical Cure at Day 3 Visit
    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
    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
    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.

    Full Information

    First Posted
    July 24, 2013
    Last Updated
    November 2, 2017
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01908803
    Brief Title
    Proof-of-Concept Study of a Single Application of an Investigational Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Terminated
    Why Stopped
    Management decision
    Study Start Date
    December 2013 (undefined)
    Primary Completion Date
    August 2014 (Actual)
    Study Completion Date
    August 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alcon Research

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Otitis Media
    Keywords
    AOMT, tympanostomy tubes, Otorrhea, anti-infective

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    84 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    AL-60371/AL-817
    Arm Type
    Experimental
    Arm Description
    AL-60371/AL-817 otic suspension, 200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)
    Arm Title
    CIPRODEX
    Arm Type
    Active Comparator
    Arm Description
    Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension, 4 drops in affected ear(s) twice daily through tympanostomy tube for 7 days
    Intervention Type
    Drug
    Intervention Name(s)
    AL-60371/AL-817 otic suspension
    Intervention Type
    Drug
    Intervention Name(s)
    Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension
    Intervention Description
    CIPRODEX®
    Primary Outcome Measure Information:
    Title
    Proportion of Subjects With Sustained Clinical Cure at Day 3 Visit
    Description
    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.
    Time Frame
    Day 3 post-treatment up to Day 8 or Early Exit
    Secondary Outcome Measure Information:
    Title
    Proportion of Subjects With Microbiological Success at the Day 8 Visit
    Description
    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.
    Time Frame
    Day 8
    Title
    Median Time (in Days) to Cessation of Otorrhea
    Description
    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.
    Time Frame
    Time to event, up to Day 8

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Clinical Manager, GCRA, Pharma
    Organizational Affiliation
    Alcon Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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