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.