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:
NCT01535599
First received: February 15, 2012
Last updated: June 21, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to evaluate an investigational drug intended to treat acute otitis externa (AOE).


Condition Intervention Phase
Acute Otitis Externa
Drug: AL-60371, 0.3% Otic Suspension
Other: 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:
  • Clinical Cure [ Time Frame: Day 11 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Microbiological Success [ Time Frame: Day 11 ] [ Designated as safety issue: No ]
    Microbiological success is attained if all pre-therapy bacteria are absent from the exit specimen.

  • Time to Cessation of Ear Pain [ Time Frame: Days ] [ Designated as safety issue: No ]
    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).


Enrollment: 693
Study Start Date: March 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AL-60371 0.3%
Four drops, twice daily, to affected ear(s) for 7 days
Drug: AL-60371, 0.3% Otic Suspension
Investigational otic suspension intended for the treatment of acute otitis externa
Placebo Comparator: AL-60371 Vehicle
Four drops, twice daily, to affected ear(s) for 7 days
Other: AL-60371 Vehicle
Otic suspension with no active ingredients

  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: NCT01535599

Locations
United States, Texas
Call Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01535599     History of Changes
Other Study ID Numbers: C-10-018
Study First Received: February 15, 2012
Last Updated: June 21, 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 20, 2014