Overview
Pharmacokinetic Study of AL-60371 Otic Suspension in Pediatric Subjects Following Tympanostomy Tube Surgery
Status:
Withdrawn
Withdrawn
Trial end date:
2015-01-01
2015-01-01
Target enrollment:
0
0
Participant gender:
All
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 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Alcon ResearchTreatments:
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.