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

• Status: Withdrawn
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Polystyrene sulfonic acid

Criteria

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.