NCT00532961

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

A Randomized, Double-masked, Parallel Comparison of Ocular Tolerance and IOP Effects of Zylet vs TobraDex Administered Four Times Daily for Four Weeks in Healthy Volunteers

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 310 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Inflammation

Interventions

Type	Name	Description
DRUG	Loteprednol etabonate 0.5% and tobramycin 0.3%	ophthalmic suspension, four times daily during the day at roughly 4 hour intervals(1-2 drops per eye)for a total of 28 days
DRUG	Dexamethasone 0.1% and tobramycin 0.3%	ophthalmic suspension, four times daily during the day at roughly 4 hour intervals (1-2 drops/eye) for a total of 28 days.

Timeline

• Start date: 2005-02-01
• Primary completion: 2005-04-01
• Completion: 2005-06-01
• First posted: 2007-09-21
• Last updated: 2011-12-08