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

Phase 3

Completed

• Conditions: Acute Otitis Externa
• Interventions: Other: AL-60371 Vehicle; Drug: AL-60371, 0.3% Otic Suspension

• Registration Number: NCT01535599
• Lead Sponsor: Alcon Research

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2012-02-15
• Study First Submitted QC: 2012-02-16
• Study First Posted: 2012-02-20
• Study Start: 2012-03
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Results First Submitted: 2014-05-19
• Results First Submitted QC: 2014-05-19
• Status Verified: 2014-06
• Results First Posted: 2014-06-18
• Last Update Submitted: 2014-06-24
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 768

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit	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. 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

Name	Time	Method
Median Time to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guardian Via the Telephone Diary	Time to event, up to Day 11	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.
Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit	Day 11	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.