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

Alcon

Status and phase

Withdrawn

Phase 1

Conditions

Otitis Media

Treatments

Drug: AL-60371 otic suspension

Study type

Interventional

Funder types

Industry

Identifiers

NCT01908764

C-13-023

Details and patient eligibility

About

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.

Sex

All

Ages

6 months to 12 years old

Volunteers

No Healthy Volunteers

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.