Zylet vs TobraDex in Blepharokeratoconjunctivitis

Phase 4 Completed 276 enrolled Bausch & Lomb Incorporated

RandomizedParallel-groupSingle-blindTreatment

Summary

The objective of this study is to evaluate the safety and efficacy of Zylet vs. Tobradex in the treatment of ocular inflammation associated with blepharokeratoconjunctivitis

Timeline

Start: 2007-01
Primary completion: 2007-06
Completion: 2007-06

Outcome

Met primary endpoint

paper LE/T satisfied the condition of non-inferiority to DM/T in decreasing the signs and symptoms of ocular inflammation associated with blepharokeratoconjunctivitis. PMID 18062846 ↗

Publications

White EM, Macy JI, Bateman KM, Comstock TL. Comparison of the safety and efficacy of loteprednol 0.5%/tobramycin 0.3% with dexamethasone 0.1%/tobramycin 0.3% in the treatment of blepharokeratoconjunctivitis. Curr Med Res Opin. 2008 Jan;24(1):287-96. doi: 10.1185/030079908x253898.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Dexamethasone	Small molecule	0.1 %	Other
Subject	Loteprednol Etabonate	Other / unclassified	0.5 %	Other
Background	Tobramycin	Unknown	0.3 %	Other