NCT01479374

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

A Multi-Center, Randomized, Double-Masked, Vehicle and Active Controlled, Parallel-Group 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: 397 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to assess the safety and efficacy of AL-4943A ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis using the Conjunctival Allergen Challenge (CAC) model.

Detailed description

This study consisted of 5 Visits. Eligible patients underwent allergy testing using the Conjunctival Allergen Challenge (CAC) model, which reproduces the signs and symptoms of Seasonal Allergic Conjunctivitis by replicating the natural disease process. Patients demonstrating a positive reaction to the CAC at Visit 1 (screening) and Visit 2 (confirmatory) were randomized to treatment at Visit 3 (Day 0). The test article was instilled at Visit 3, with treatment efficacy CAC performed at 24 hours duration of action. The test article was instilled again at Visit 4 (Day 14), with treatment efficacy CAC performed at 16 hours duration of action. The test article was instilled a final time at Visit 5 (Day 21), with treatment efficacy performed at onset of action.

Conditions

• Allergic Conjunctivitis

Interventions

Type	Name	Description
DRUG	AL-4943A ophthalmic solution
DRUG	AL-4943A vehicle	Inactive ingredients used as placebo
DRUG	Olopatadine hydrochloride ophthalmic solution, 0.2%

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2011-11-24
• Last updated: 2013-06-04
• Results posted: 2013-05-23