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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01535560
First received: February 15, 2012
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

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).


Condition Intervention Phase
Acute Otitis Externa
Drug: AL-60371, 0.3% otic suspension
Drug: AL-60371 Vehicle
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit [ Time Frame: Day 11 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit [ Time Frame: Day 11 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 589
Study Start Date: April 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AL-60371
AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
Drug: AL-60371, 0.3% otic suspension
Investigational otic suspension intended for the treatment of acute otitis externa
Placebo Comparator: Vehicle
AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
Drug: AL-60371 Vehicle
Inactive ingredients used as placebo

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01535560

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Sally Schieb Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01535560     History of Changes
Other Study ID Numbers: C-10-019
Study First Received: February 15, 2012
Results First Received: October 18, 2013
Last Updated: October 18, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alcon Research:
Acute otitis externa

Additional relevant MeSH terms:
Otitis Externa
Otitis
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on April 23, 2014