NCT00420628

Pediatric Zylet Safety and Efficacy Study

A Safety and Efficacy Study of Zylet® (Loteprednol Etabonate 0.5% and Tobramycin 0.3% Ophthalmic Suspension) Compared to Vehicle in the Management of Lid Inflammation (Chalazion/Hordeolum) in Pediatric Subjects

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

A multicenter study to evaluate the safety and efficacy of Zylet compared to vehicle in children aged 0-6 for the management of lid inflammation (chalazion/hordeolum)

Conditions

• Chalazion
• Hordeolum

Interventions

Type	Name	Description
DRUG	loteprednol etabonate/tobramycin opthalmic suspension	Topical ophthalmic drug: 0.5% loteprednol etabonate with 0.3% tobramycin 4 times a day (QID) days 1-7, 2 times a day (BID) days 8-14. Warm compresses were applied to affected eyes 2 times a day prior to application of study medication.
DRUG	vehicle	topical ophthalmic vehicle was applied 4 times a day (QID) days 1-7, 2 times a day (BID) days 8-14. Warm compresses were applied to affected eyes 2 times a day prior to application of study medication.

Timeline

• Start date: 2006-11-01
• Primary completion: 2009-01-01
• Completion: 2009-06-01
• First posted: 2007-01-11
• Last updated: 2011-10-07
• Results posted: 2010-09-22

Locations

1 site across 1 country: United States