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 24, 2014
Last verified: June 2014
  Purpose

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).


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:
  • 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. 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 [ Time Frame: Day 11 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Time to event, up to Day 11 ] [ Designated as safety issue: No ]
    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.


Enrollment: 768
Study Start Date: March 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AL-60371
AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
Drug: AL-60371, 0.3% Otic Suspension
Placebo Comparator: Vehicle
AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
Other: AL-60371 Vehicle
Inactive ingredients used as a placebo comparator

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01535599

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Sally Scheib, Sr. Clinical Project Lead 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
Results First Received: May 19, 2014
Last Updated: June 24, 2014
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
Otitis Externa
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on September 22, 2014