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

NCT ID: NCT01535560

Last Updated: 2013-12-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

589 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-10-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Acute Otitis Externa

Keywords

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Acute otitis externa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AL-60371

AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days

Group Type EXPERIMENTAL

AL-60371, 0.3% otic suspension

Intervention Type DRUG

Investigational otic suspension intended for the treatment of acute otitis externa

Vehicle

AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days

Group Type PLACEBO_COMPARATOR

AL-60371 Vehicle

Intervention Type DRUG

Inactive ingredients used as placebo

Interventions

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AL-60371, 0.3% otic suspension

Investigational otic suspension intended for the treatment of acute otitis externa

Intervention Type DRUG

AL-60371 Vehicle

Inactive ingredients used as placebo

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sally Schieb

Role: STUDY_DIRECTOR

Alcon Research

Countries

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United States

Other Identifiers

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C-10-019

Identifier Type: -

Identifier Source: org_study_id