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

Completed · Phase 4

Conditions studied: Conjunctivitis

In brief

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.

Key facts

Study ID

NCT00705159

Run by

Bausch & Lomb Incorporated

People needed

137

Starts

2008-06-01

Expected to finish

2010-05-01

Last updated by the study team

2015-03-24

Who can join

Age: 0 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pediatric Ophthalmology of Erie — Erie, Pennsylvania, United States

Full record on ClinicalTrials.gov

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