NCT00836485

Evaluation of the Safety and Efficacy of Ketotifen 4.0% Patch as Compared to Placebo Patch, Olopatadine 0.2% Ophthalmic Solution, and Artificial Tears in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis

A Prospective, Multi-Center, Double-Masked, Randomized, Placebo-Controlled Evaluation of the Safety and Efficacy of Ketotifen 4.0% Patch as Compared to Placebo Patch, Olopatadine 0.2% Ophthalmic Solution, and Artificial Tears in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Senju USA, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2 study that will consist of 4 visits over a 5 week period. Drug will be evaluated using the conjunctival allergen challenge model of allergic conjunctivitis.

Conditions

• Allergic Conjunctivitis

Interventions

Type	Name	Description
DRUG	Ketotifen 4.0% Patch	This investigational drug is a transdermal patch indicated to treat allergic conjunctivitis. Application is intended for overnight wear between 8-10 hours.
DRUG	Placebo	The control is a placebo patch that contains only the inactive ingredients of ketotifen.
DRUG	Olopatadine 0.2%	1 gtt/eye on two separate occasions
DRUG	Artificial tears	1 gtt/eye on two separate occasions

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2009-02-04
• Last updated: 2023-08-04

Locations

1 site across 1 country: United States