NCT00770133

Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis.

A Multi-center, Double-masked, Randomized, Placebo-controlled Evaluation of the Onset and Duration of Action of KetoNaph Ophthalmic Solution in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline ophthalmic solution compared to vehicle and its individual components in alleviating the signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis.

Conditions

• Allergic Conjunctivitis

Interventions

Type	Name	Description
DRUG	Ketotifen/naphazoline	One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.
DRUG	Naphazoline	One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.
DRUG	Ketotifen	One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.
DRUG	Vehicle	One drop of vehicle ophthalmic solution at visit 3 and visit 4.

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-04-01
• Completion: 2010-06-01
• First posted: 2008-10-09
• Last updated: 2020-10-27
• Results posted: 2020-10-27

Locations

1 site across 1 country: United States