NCT01743027

Efficacy and Safety of an Ophthalmic Solution in Patients With Allergic Conjunctivitis

Phase 3, Efficacy and Safety Study of AL-4943A Ophthalmic Solution, 0.77% in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge (CAC) Model

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 902 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate an ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis using the Conjunctival Allergen Challenge (CAC) model.

Detailed description

Enrolled participants will be tested for the presence of common allergies using the Conjunctival Allergen Challenge (CAC) model. Drops of increasing concentration of a solubilized allergen will be instilled in both eyes until a positive reaction occurred. The test will be repeated to confirm the allergic reaction. Participants with confirmed reactions will be administered the test article (Day 0) and undergo a CAC 24 hours post-instillation (Day 1). On Day 14, participants will be administered the test article and undergo an additional CAC.

Conditions

• Allergic Conjunctivitis

Interventions

Type	Name	Description
DRUG	AL-4943A ophthalmic solution
DRUG	Olopatadine hydrochloride ophthalmic solution, 0.2%
DRUG	Olopatadine hydrochloride ophthalmic solution, 0.1%
DRUG	AL-4943A ophthalmic solution vehicle

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2012-12-06
• Last updated: 2014-08-11
• Results posted: 2014-08-11