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

Alcon

Status and phase

Completed

Phase 3

Conditions

Acute Otitis Externa

Treatments

Other: AL-60371 Vehicle

Drug: AL-60371, 0.3% Otic Suspension

Study type

Interventional

Funder types

Industry

Identifiers

NCT01535599

C-10-018

Details and patient eligibility

About

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).

Full 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.

Enrollment

768 patients

Sex

All

Ages

6+ months old

Volunteers

No Healthy Volunteers

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.