NCT00560638

Loteprednol Etabonate Opthalmic Suspension for the Treatment of Dry Eye

A Double-Masked, Randomized, Placebo-Controlled Study of Loteprednol Etabonate Ophthalmic Suspension, 0.5% for the Treatment of Dry Eye Used Either TID or QID for a 2 Week Period

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was a single-center, randomized, double-masked, placebo-controlled, parallel-group, 4-visit, CAE (Controlled Adverse Environment) study lasting approximately 4 weeks. Subjects were randomized to receive loteprednol etabonate ophthalmic suspension, 0.5% or placebo (vehicle of loteprednol etabonate ophthalmic suspension, 0.5%) and instructed to dose bilaterally either TID or QID according to randomization.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	loteprednol etabonate ophthalmic suspension, 0.5%	TID
DRUG	loteprednol etabonate ophthalmic suspension, 0.5%	QID
DRUG	vehicle of loteprednol etabonate	TID or BID according to the randomization

Timeline

• Start date: 2005-11-01
• Primary completion: 2006-02-01
• Completion: 2006-02-01
• First posted: 2007-11-20
• Last updated: 2011-07-18

Locations

1 site across 1 country: United States