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

Phase 2TerminatedNCT01908803

Alcon Research84 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Acute Otitis Media

Interventions

AL-60371/AL-817 otic suspensionDRUG

Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspensionDRUG

CIPRODEX®

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 12 Years

Medical Language ↔ Plain English

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; * Other protocol-defined inclusion criteria may apply. 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; * Other protocol-defined exclusion criteria may apply.

Outcomes

Primary Outcomes

Proportion of Subjects With Sustained Clinical Cure at Day 3 Visit

A sustained clinical cure at Day 3 was attained if otorrhea was absent at the Day 3 visit and continued to be absent through the last study visit (Day 8 or Early Exit). Proportion of subjects is reported as a percentage.

Time frame: Day 3 post-treatment up to Day 8 or Early Exit

Secondary Outcomes

Proportion of Subjects With Microbiological Success at the Day 8 Visit

Microbiological success was attained if all pre-therapy bacteria were absent in the Day 8 specimen. In a subject with no otorrhea at Day 8, eradication of pre-therapy bacteria was presumed and the subject was considered a microbiological success.

Time frame: Day 8

Median Time (in Days) to Cessation of Otorrhea

Median time (in days) to the cessation of otorrhea (ie, otorrhea was absent) was calculated as the number of days from the Day 1 (Visit 1) to the absence of otorrhea in the affected ear(s) as recorded by the parent/guardian via the twice-daily diary. Cessation of otorrhea was defined as ending on the first day that otorrhea was absent from the affected ear(s) and remained absent for any/all subsequent diary entries.

Time frame: Time to event, up to Day 8

Data from ClinicalTrials.gov

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