Overview

Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis

Status:
Completed
Trial end date:
2010-05-01
Target enrollment:
0
Participant gender:
All
Summary
The objective of this study is to evaluate the safety and effectiveness of Zylet in comparison with Lotemax, Tobramycin and the vehicle of Zylet for the treatment of blepharoconjunctivitis in pediatric subjects.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bausch & Lomb Incorporated
Treatments:
Loteprednol Etabonate
Tobramycin
Criteria
Inclusion Criteria:

- children 0-6 years of age.

- clinical diagnosis of blepharoconjunctivitis

- Parent/guardian must understand, be willing and able to comply with all treatment and
follow-up procedures.

- Parent/guardian must understand, be willing and able to provide informed consent and
Health Insurance Portability Accountability Act (HIPAA) authorization.

Exclusion Criteria:

- Known hypersensitivity to corticosteroids, aminoglycosides, or any component of the
study medication.

- Subjects who have a history of ocular surgery, including laser procedures, within the
past 6 months.

- Subjects who are monocular.

- Subjects who have a history of any severe/serious ocular pathology or medical
condition that could result in the subject's inability to complete the study.

- Subjects who have participated in an ophthalmic drug or device research study within
30 days prior to entry in this study.