Assessment of Alcon's Ocular Image Quantification System

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

Detailed Description
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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.

Official Title
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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)

Conditions
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Allergic Conjunctivitis

Intervention / Treatment
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* Drug: Olopatadine hydrochloride, 0.1% ophthalmic solution (Patanol)
* Other: Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patanol<br>One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing. | Drug: Olopatadine hydrochloride, 0.1% ophthalmic solution (Patanol)<br>* One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.<br>* Other names: Patanol®;|
| Placebo Comparator: Tears Naturale II<br>One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing. | Other: Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II)<br>* One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.<br>* Other names: Tears Naturale II;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Patient-Assessed Ocular Itching, Environmental Exposure Chamber (EEC), at 3 Hours | As assessed by the participant after 3 hours in the EEC. Ocular itching was graded on a 0-4 scale, where 0=none, 1=tickling sensation involving one or more corners of the eye, 2=all over tickling sensation; 3=moderate continuous itching with desire to rub; 4=severe itching with irresistible urge to rub. | Baseline, 3 hours | 
| Change From Baseline in Patient-Assessed Ocular Itching, Conjunctival Allergen Provocation Test (CAPT), at 3 Hours | As assessed by the participant after 3 hours of CAPT. Ocular itching was graded on a 0-4 scale, where 0=none, 1=tickling sensation involving one or more corners of the eye, 2=all over tickling sensation; 3=moderate continuous itching with desire to rub; 4=severe itching with irresistible urge to rub. | Baseline, 3 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergic conjunctivitis