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

Primary Purpose

Acute Otitis Externa

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

AL-60371, 0.3% otic suspension

AL-60371 Vehicle

About this trial

This is an interventional treatment trial for Acute Otitis Externa focused on measuring Acute otitis externa

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AL-60371

Vehicle

Arm Description

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

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

Outcomes

Primary Outcome Measures

Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit

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. Proportion of patients is reported as percentage of participants.

Secondary Outcome Measures

Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit

Microbiological success was considered attained if all pre-therapy bacteria were absent from the exit otic specimen. The presence of fungi and/or yeast was not considered in the determination of microbiological success. Proportion of patients is reported as a percentage of participants.

Median Time (in Days) to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guadian Via the Telephone Diary

Cessation of ear pain was defined as occurring the first time point that ear pain was absent (morning or evening) and did not reoccur in any subsequent diary entries.

Full Information

NCT ID

NCT01535560

First Posted

February 15, 2012

Last Updated

October 18, 2013

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT01535560

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

April 2012 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alcon Research

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Otitis Externa

Keywords

Acute otitis externa

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

589 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AL-60371

Arm Type

Experimental

Arm Description

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

Arm Title

Vehicle

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

AL-60371, 0.3% otic suspension

Intervention Description

Investigational otic suspension intended for the treatment of acute otitis externa

Intervention Type

Drug

Intervention Name(s)

AL-60371 Vehicle

Intervention Description

Inactive ingredients used as placebo

Primary Outcome Measure Information:

Title

Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit

Description

Time Frame

Day 11

Secondary Outcome Measure Information:

Title

Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit

Description

Time Frame

Day 11

Title

Median Time (in Days) to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guadian Via the Telephone Diary

Description

Cessation of ear pain was defined as occurring the first time point that ear pain was absent (morning or evening) and did not reoccur in any subsequent diary entries.

Time Frame

Time to event (Day 1 to Day 11)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sally Schieb

Organizational Affiliation

Alcon Research

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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