Study of the Effect of Fluticasone Furoate Nasal Spray on Spring Allergy Eye Symptoms

Study Overview
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Brief Summary
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Rationale and objectives: Fluticasone furoate nasal spray (Veramyst) has been shown to improve ocular symptoms when used for the treatment of seasonal allergic rhinitis during the ragweed pollen season. Although this is the only published report of an intranasal corticosteroid shown to effectively treat ocular symptoms, the mechanism has not been delineated. Furthermore, the tears of patients with allergic conjunctivitis are known to have increased concentrations of cytokines and allergic mediators. The objective of this study is to determine if the positive effects of Veramyst nasal spray on ocular symptoms is via the inhibition of allergic mediators in the eyes. The investigators will conduct a double blind placebo controlled trial to determine if Veramyst nasal spray decreases the amount of allergic mediators in the tears of subjects randomized to Veramyst nasal spray versus placebo. The investigators will also compare the subjects' symptoms to the amount of allergic mediators detected in their tears.

Official Title
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Comparison of the Effect of Fluticasone Furoate Nasal Spray Versus Placebo on Allergic Mediators in the Tears of Subjects With Tree or Grass Pollen Allergy

Conditions
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Allergic Conjunctivitis to Tree Pollen or Grass Pollen

Intervention / Treatment
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* Drug: Fluticasone furoate nasal spray
* Drug: Placebo nasal spray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a documented history of allergic rhinitis and conjunctivitis due to tree pollen and / or grass pollen for two allergy seasons positive skin prick test to tree and / or grass Exclusion Criteria: glaucoma cataracts acute or chronic sinusitis asthma chronic obstructive pulmonary disease physical nasal obstruction pregnant or breastfeeding have had a viral or bacterial infections within 2 weeks of the study commencement receiving allergen immunotherapy have used inhaled corticosteroids within 14 days prior to the study have used systemic corticosteroids within 30 days of the study travel outside of the geographic area during the 2 week study period use of contact lenses during the study period use of artificial tears during the study period use of eyewash irrigation during the study period use of lubricants during the study period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo nasal spray<br> | Drug: Placebo nasal spray<br>* 2 sprays each nostril every morning for 2 weeks<br>|
| Active Comparator: Fluticasone furoate nasal spray<br> | Drug: Fluticasone furoate nasal spray<br>* 2 sprays each nostril every morning for 2 weeks<br>* Other names: Veramyst;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eosinophilic Cationic Protein (ECP) Levels | Tear samples from the participants eyes were collect and were to be used for measuring esinophilic cationic prtein, but this was not measured because the volume of tears were to low. | Samples taken at initial visit & 2 week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histamine Content in the Tears Was Measured. | Tear samples were assayed for histamine by ELISA | Samples taken at initial visit & 2 week follow-up |