Ocular Tolerance and Intraocular Pressure (IOP) Effects of Zylet Versus Tobradex

Phase 4 Completed 310 enrolled Bausch & Lomb Incorporated

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Phase IV, randomized, double-masked, parallel-group clinical trial comparing the ocular tolerability and steroid-induced intraocular pressure (IOP) effects of Zylet wth that of TobraDex in healthy volunteers, when either product was administered QID (at approximately 4-hour intervals) for 28 days.

Timeline

Start: 2005-02
Primary completion: 2005-04
Completion: 2005-06

Publications

Bartlett JD, Holland EJ, Usner DW, Paterno MR, Comstock TL. Tolerability of loteprednol/tobramycin versus dexamethasone/tobramycin in healthy volunteers: results of a 4-week, randomized, double-masked, parallel-group study. Curr Med Res Opin. 2008 Aug;24(8):2219-27. doi: 10.1185/03007990802231981. Epub 2008 Jun 23.

Drugs

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

Indications

No indication recorded.