Pharmacokinetic Study of AL-60371 Otic Suspension in Pediatric Subjects Following Tympanostomy Tube Surgery

Phase 1WithdrawnNCT01908764

Alcon Research

Overview

The purpose of this study is to describe the pharmacokinetics of AL-60371 otic suspension following two posologies of bilateral ototopical doses in pediatric subjects immediately after bilateral tympanostomy tube surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Conditions

Otitis Media

Interventions

AL-60371 otic suspensionDRUG

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Requires bilateral myringotomy and tympanostomy tube insertion; * Provides informed consent (parent/legal guardian); * Signs assent form where applicable (subject); * Accompanied by parent/legal guardian at each visit; * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Menarcheal females; * Current or recent history of any disease which, in the opinion of the Principal Investigator, may place the subject at risk or interfere with study; * Use of excluded medications within one week prior to surgery and for the duration of the study; * Requires another surgical procedure in addition to the myringotomy; * Clinically relevant otic condition which, in the opinion of the Principal Investigator, would preclude the safe administration of the study medication; * Participation in any other investigational study within 30 days before entry into this study or along with this study; * Known or suspected allergy or hypersensitivity to any active or inactive ingredient in the test article; * Other protocol-defined exclusion criteria may apply.