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Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa

Primary Purpose

Acute Otitis Externa

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
AL-60371, 0.3% Otic Suspension
AL-60371 Vehicle
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Otitis Externa focused on measuring Acute Otitis Externa

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • At least 6 months of age.
  • Clinical diagnosis of acute otitis externa (AOE) based on clinical observation and of presumed bacterial origin in at least one ear.
  • Combined numerical score of ≥4 in at least one affected ear at the Day 1 exam for tenderness, erythema, and edema.
  • Agree to refrain from water immersion of the ears during the conduct of the entire study.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Duration of signs or symptoms of AOE greater than 28 days in the affected ear(s) as reported by patient or parent/guardian.
  • Presence of a tympanostomy tube or perforated tympanic membrane in the affected ear(s).
  • Clinically diagnosed otic disease other than AOE (eg, malignant otitis externa) in the affected ear(s).
  • Known or suspected ear infection of yeast, fungal or mycobacterial origin in the affected ear(s).
  • Prior otologic surgery within 6 months of study entry in the affected ear(s).
  • Known or suspected allergy or hypersensitivity to quinolones or other ingredients present in the medications to be used in the study.
  • Patients who use ear plugs, head phones or ear buds and are unwilling to discontinue their use during the study period.
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    AL-60371

    Vehicle

    Arm Description

    AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days

    AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days

    Outcomes

    Primary Outcome Measures

    Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit
    An otoscopic exam was conducted by the physician. Clinical cure was considered attained if the sum of the numerical scores of the 3 signs and symptoms of AOE (tenderness, erythema, and edema) was 0 at Day 11. In this analysis, the clinical cure outcome at Day 11 (TOC) was considered a failure for all pathogen positive patients who did not complete the study (for any reason). Proportion of patients is reported as a percentage.

    Secondary Outcome Measures

    Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit
    Microbiological success was considered attained if all pretherapy bacteria were absent from the exit otic specimen. The presence of fungi and/or yeast was not considered in the determination of microbiological success. In this analysis, the microbiological success value at Day 11 (TOC) was considered a failure for all pathogen positive patients who did not complete the study (for any reason). Proportion of patients is reported as a percentage.
    Median Time to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guardian Via the Telephone Diary
    Cessation of ear pain was defined as occurring on the first time point that ear pain was absent (morning or evening) and did not return in any subsequent diary entries. Day 1 was the starting point for this time-to-event analysis. For this analysis, all patients who did not complete the study and ear pain never ceased had their ear pain considered as being present throughout the planned duration of the study.

    Full Information

    First Posted
    February 15, 2012
    Last Updated
    June 24, 2014
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01535599
    Brief Title
    Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
    Official Title
    Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2012 (undefined)
    Primary Completion Date
    May 2013 (Actual)
    Study Completion Date
    May 2013 (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 was to demonstrate the superiority of AL-60371, 0.3% Otic Suspension relative to AL-60371 Vehicle based on clinical cures at test-of-cure (TOC) for the treatment of acute otitis externa (AOE).
    Detailed Description
    Patients were evaluated for safety and efficacy during the visits conducted at Day 3 (on-therapy), Day 8 (end-of-therapy), and Day 11 (TOC). Patients or parents/legal guardians completed a telephone diary twice daily to record assessments of ear pain, ear pain medication use, and the impact of ear pain on sleep and other daily activities.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Otitis Externa
    Keywords
    Acute Otitis Externa

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    768 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    AL-60371
    Arm Type
    Experimental
    Arm Description
    AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
    Arm Title
    Vehicle
    Arm Type
    Placebo Comparator
    Arm Description
    AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
    Intervention Type
    Drug
    Intervention Name(s)
    AL-60371, 0.3% Otic Suspension
    Intervention Type
    Other
    Intervention Name(s)
    AL-60371 Vehicle
    Intervention Description
    Inactive ingredients used as a placebo comparator
    Primary Outcome Measure Information:
    Title
    Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit
    Description
    An otoscopic exam was conducted by the physician. Clinical cure was considered attained if the sum of the numerical scores of the 3 signs and symptoms of AOE (tenderness, erythema, and edema) was 0 at Day 11. In this analysis, the clinical cure outcome at Day 11 (TOC) was considered a failure for all pathogen positive patients who did not complete the study (for any reason). Proportion of patients is reported as a percentage.
    Time Frame
    Day 11
    Secondary Outcome Measure Information:
    Title
    Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit
    Description
    Microbiological success was considered attained if all pretherapy bacteria were absent from the exit otic specimen. The presence of fungi and/or yeast was not considered in the determination of microbiological success. In this analysis, the microbiological success value at Day 11 (TOC) was considered a failure for all pathogen positive patients who did not complete the study (for any reason). Proportion of patients is reported as a percentage.
    Time Frame
    Day 11
    Title
    Median Time to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guardian Via the Telephone Diary
    Description
    Cessation of ear pain was defined as occurring on the first time point that ear pain was absent (morning or evening) and did not return in any subsequent diary entries. Day 1 was the starting point for this time-to-event analysis. For this analysis, all patients who did not complete the study and ear pain never ceased had their ear pain considered as being present throughout the planned duration of the study.
    Time Frame
    Time to event, up to Day 11

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: At least 6 months of age. Clinical diagnosis of acute otitis externa (AOE) based on clinical observation and of presumed bacterial origin in at least one ear. Combined numerical score of ≥4 in at least one affected ear at the Day 1 exam for tenderness, erythema, and edema. Agree to refrain from water immersion of the ears during the conduct of the entire study. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Duration of signs or symptoms of AOE greater than 28 days in the affected ear(s) as reported by patient or parent/guardian. Presence of a tympanostomy tube or perforated tympanic membrane in the affected ear(s). Clinically diagnosed otic disease other than AOE (eg, malignant otitis externa) in the affected ear(s). Known or suspected ear infection of yeast, fungal or mycobacterial origin in the affected ear(s). Prior otologic surgery within 6 months of study entry in the affected ear(s). Known or suspected allergy or hypersensitivity to quinolones or other ingredients present in the medications to be used in the study. Patients who use ear plugs, head phones or ear buds and are unwilling to discontinue their use during the study period. Other protocol-defined exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sally Scheib, Sr. Clinical Project Lead
    Organizational Affiliation
    Alcon Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa

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