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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: The purpose of this study was to demonstrate superiority of AL-60371 relative to Vehicle based on clinical cures at test-of-cure (TOC) for the treatment of acute otitis externa (AOE).

Detailed Summary: Participants or legal guardians completed a telephone diary twice daily to record assessments of ear pain, ear medication use, and impact of ear pain on sleep and other daily activities.
Sponsor: Alcon Research

Current Primary Outcome: Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit [ Time Frame: Day 11 ]

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. Proportion of patients is reported as percentage of participants.


Original Primary Outcome: Clinical Cure [ Time Frame: Day 11 ]

Clinical cure is attained if the sum of the numerical scores of the 3 signs and symptoms of AOE tenderness, erythema, and edema) is 0 at Day 11.


Current Secondary Outcome:

  • Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit [ Time Frame: Day 11 ]
    Microbiological success was considered attained if all pre-therapy bacteria were absent from the exit otic specimen. The presence of fungi and/or yeast was not considered in the determination of microbiological success. Proportion of patients is reported as a percentage of participants.
  • Median Time (in Days) to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guadian Via the Telephone Diary [ Time Frame: Time to event (Day 1 to Day 11) ]
    Cessation of ear pain was defined as occurring the first time point that ear pain was absent (morning or evening) and did not reoccur in any subsequent diary entries.


Original Secondary Outcome:

  • Microbiological Success [ Time Frame: Day 11 ]
    Microbiological success is attained if all pre-therapy bacteria are absent from the exit specimen.
  • Time to Cessation of Ear Pain [ Time Frame: Days ]
    Cessation of ear pain will be defined as occurring on the first time point that ear pain is absent (morning or evening) and does not return for all subsequent diary entries (as reported by the patient or parent/guardian).


Information By: Alcon Research

Dates:
Date Received: February 15, 2012
Date Started: March 2012
Date Completion:
Last Updated: October 18, 2013
Last Verified: October 2013