NCT01275105

A Single-Center, Randomized, Double-Masked, Placebo and Active Controlled, Dose-Ranging Evaluation of the Duration of Action of Brimonidine Tartrate Ophthalmic Solution in the Control of Ocular Redness Induced by Conjunctival Allergen Challenge (CAC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Eye Therapies, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, efficacy, and dose response of brimonidine tartrate ophthalmic solution as compared to placebo in the prevention of allergen-induced conjunctival redness using a conjunctival allergen challenge (CAC) model. It is hypothesized that low-dose brimonidine tartrate ophthalmic solution will be more effective than vehicle in the prevention of conjunctival redness induced by conjunctival allergen challenge when instilled prior to the allergen challenge.

Conditions

• Allergic Conjunctivitis

Interventions

Type	Name	Description
DRUG	Vehicle	one drop in each eye at designated visits
DRUG	Brimonidine Tartrate 0.01%	one drop in each eye at designated visits
DRUG	Brimonidine Tartrate 0.025%	one drop in each eye at designated visits
DRUG	Oxymetazoline HCl 0.025%	one drop in each eye at designated visits

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2011-01-12
• Last updated: 2012-03-06

Locations

1 site across 1 country: United States