NCT01107405

Loteprednol Ophthalmic Base Compared to Loteprednol Ophthalmic Suspension vs Placebo in an Allergen Challenge

Efficacy of Loteprednol Etabonate Ophthalmic Base Compared to Loteprednol Etabonate Ophthalmic Suspension vs Placebo in a Modified Conjunctival Allergen Challenge(CAC) Model

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of loteprednol etabonate ophthalmic base, compared to loteprednol etabonate ophthalmic suspension, and vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in a modified Conjunctival Allergen Challenge model and in an environmental model during pollen season. Comparisons will be made following 2 weeks of dosing.

Conditions

• Allergic Conjunctivitis

Interventions

Type	Name	Description
DRUG	Loteprednol etabonate base (QD)	Loteprednol Etabonate ophthalmic base once daily dosing for 2 weeks
DRUG	Loteprednol etabonate base (BID)	Loteprednol etabonate ophthalmic base BID dosing for 2 weeks
DRUG	Loteprednol etabonate base (QID)	Loteprednol Etabonate ophthalmic base four times/day dosing for 2 week
DRUG	Loteprednol etabonate suspension	Loteprednol etabonate ophthalmic suspension dosed four times daily for 2 weeks.
DRUG	Vehicle of loteprednol etabonate	Vehicle of loteprednol etabonate ophthalmic dosed once, twice or four times daily for 2 weeks.

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-05-01
• Completion: 2010-08-01
• First posted: 2010-04-21
• Last updated: 2012-03-21
• Results posted: 2012-03-21

Locations

1 site across 1 country: United States