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Proof-of-Concept Study of a Single Application of an Investigational Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes

NCT ID: NCT01908803

Last Updated: 2017-12-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-08-31

Brief Summary

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The purpose of this study is to evaluate a single application of AL-60371/AL-817 Otic Suspension relative to ototopical CIPRODEX for sustained clinical cure, microbiological success, and time to cessation of otorrhea.

Detailed Description

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The results at the time of the interim analysis met the futility criteria and the study was subsequently stopped.

Conditions

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Acute Otitis Media

Keywords

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AOMT tympanostomy tubes Otorrhea anti-infective

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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AL-60371/AL-817

AL-60371/AL-817 otic suspension, 200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)

Group Type EXPERIMENTAL

AL-60371/AL-817 otic suspension

Intervention Type DRUG

CIPRODEX

Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension, 4 drops in affected ear(s) twice daily through tympanostomy tube for 7 days

Group Type ACTIVE_COMPARATOR

Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension

Intervention Type DRUG

CIPRODEX®

Interventions

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AL-60371/AL-817 otic suspension

Intervention Type DRUG

Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension

CIPRODEX®

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Parent or guardian: Read and sign the informed consent. When required by the Institutional Review Board, child must agree to sign an approved assent form;
* Presence of otorrhea (visible by parent or guardian) of 21 days or less in duration;
* Presence of patent tympanostomy tubes;
* Refrain from water immersion of the ears following surgery without the use of adequate ear protection during swimming, bathing, showering and other water-related activities;
* Parent or guardian: Agree to comply with the requirements of the study, administer the study medication as directed, complete required study visits, and comply with the protocol;

Exclusion Criteria

* NOT otorrhea-free for at least seven days following tympanostomy tube surgery;
* Menarcheal females;
* Previous otologic surgery, except tympanic membrane, within one year of study entry;
* History of/or current acute or chronic non-tube otorrhea (through existing perforation of the eardrum);
* Current acute otitis externa, malignant otitis externa, or other conditions which could interfere with evaluation of the study drug;
* Diabetic (controlled or uncontrolled);
* Use of prohibited medications;
Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Years

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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Clinical Manager, GCRA, Pharma

Role: STUDY_DIRECTOR

Alcon Research

Countries

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United States

Other Identifiers

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C-13-026

Identifier Type: -

Identifier Source: org_study_id