Effect of Olopatadine on Allergic Tear Mediators

Study Overview
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Brief Summary
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The purpose of the research is to determine which inflammatory substances are involved in causing allergic symptoms in the eye. Allergic conjunctivitis is a common problem with symptoms of temporary redness, itching, tearing, and swelling of the eyes. Substances released by cells in the affected tissues cause allergic reactions in the eye and elsewhere in the body.

Detailed Description
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Ocular allergies are extremely common, affecting up to 80 million people in the USA. Our research question is: Are there differences in inflammatory mediators and cell surface activation markers in patients undergoing seasonal allergic conjunctivitis compared to those with sight threatening disease such as Atopic Keratoconjunctivitis (AKC) and will the use of the anti-allergy eye drop, PATANOL® (olopatadine hydrochloride) affect these parameters? Experimental Design: Ocular surface cells (by impression cytology) and tears (via capillary tube) are collected from allergic, non-allergic, and AKC subjects undergoing an reaction induced either by seasonal allergen or topical allergen provocation (specificity and dose determined via skin testing). Ocular surface cells are evaluated for surface activation markers. Tears are evaluated for mediator content. Tears are also incubated with peripheral blood eosinophils and lymphocytes to see effects on adhesion to conjunctival epithelial cells.

Official Title
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Expression of Inflammatory Mediators in Allergic Conjunctivitis

Conditions
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Allergic Conjunctivitis

Intervention / Treatment
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* Drug: olopatadine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Skin test positive Able to put drops in eyes Able to have tears collected

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Olopatadine<br>one drop in one eye only two times per day at an interval of 6 to 8 hours for 1 week | Drug: olopatadine<br>* olopatadine one drop in one eye for one week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study Examined Whether the Incubation of Human Conjunctival Epithelial Cells With Tears Pooled From Allergic Subjects (One Eye With and Other Eye Without Olopatadine Treatment) Promotes Eosinophil Adhesion | Outcome: The collected tears (from 10 subjects)were pooled, incubated with primary conjunctival epithelial cells before eosinophil adhesion was measured via eosinophil peroxidase assay. Eosinophils in eosinophils / square cm measured. | 1 week for tear collection, tears stored at - 80 C until used | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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olopatadine, tears, conjunctival epithelial cells, eosinophils