NCT01028027

Loteprednol and Tobramycin Versus Tobramycin and Dexamethasone, in the Treatment of Blepharokeratoconjunctivitis

A Clinical Safety and Efficacy Evaluation of Zylet® Versus Tobradex in the Treatment of Blepharokeratoconjunctivitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 357 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the safety and efficacy of loteprednol etabonate \[LE\] and tobramycin ophthalmic suspension versus tobramycin and dexamethasone ophthalmic suspension in the treatment of ocular inflammation associated with blepharokeratoconjunctivitis (BKC).

Conditions

• Conjunctivitis
• Keratitis
• Blepharitis

Interventions

Type	Name	Description
DRUG	Loteprednol and tobramycin	Loteprednol etabonate and tobramycin ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days.
DRUG	Tobramycin and dexamethasone	Tobramycin and dexamethasone ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days.

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-02-01
• Completion: 2010-03-01
• First posted: 2009-12-09
• Last updated: 2012-02-28
• Results posted: 2011-09-15

Locations

1 site across 1 country: Singapore