NCT00769886

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

A Multi-Center, Double-Masked, Randomized, Vehicle and Active Controlled Evaluation of the Onset and Duration of Action of KetoNaph Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 144 (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/naphazoline in study eye at visit 3 and visit 4.
DRUG	Ketotifen	One drop of Ketotifen in study eye at visit 3 and visit 4.
DRUG	Naphazoline	One drop of naphazoline in study eye at vist 3 and visit 4.
DRUG	Vehicle	One drop of vehicle in study eye at visit 3 and visit 4.

Timeline

• Start date: 2008-10-01
• Primary completion: 2008-12-01
• Completion: 2009-06-01
• First posted: 2008-10-09
• Last updated: 2024-04-03
• Results posted: 2020-10-27

Locations

1 site across 1 country: United States