Assessment of Alcon's Ocular Image Quantification System

A Study to Assess Alcon's Ocular Image Quantification Using Conjunctival Allergan Provocation Testing (CAPT) and Natural Allergen Exposure in an Environmental Exposure Chamber (EEC)

The purpose of this study was to evaluate ocular responses with different allergen provocation methods.

Subjects demonstrating a successful allergen response to a common allergen received the first study treatment and used as instructed for 5 days, after which they entered the Environmental Exposure Chamber (EEC) for a 3-hour exposure to a known concentration of the allergen. After waiting at least 7 days, subjects received the second study treatment and used as instructed for 5 days, after which a 3-hour Conjunctival Allergen Provocation Test (CAPT) was performed with an escalating concentration of the allergen. Subjects dosed with study treatment approximately 15 minutes prior to each allergen provocation test.

Inclusion Criteria:

• History of allergic conjunctivitis;
• Active signs and symptoms of ocular allergies;
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• History of dry eye;
• Presence of ocular infection;
• Presence of severe or serious ocular conditions;
• Symptoms of allergic conjunctivitis;
• Use of topical or systemic ocular medications as specified in protocol;
• Ocular surgery or laser surgery within 6 months of study start;
• Unwilling to discontinue contact lens wear 72 hours prior to Visit 1 and during study period;
• Other protocol-defined exclusion criteria may apply.