Allergic Conjunctivitis to Tree Pollen or Grass Pollen Clinical Trial
Official title:
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
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | August 2009 |
| Est. primary completion date | July 2009 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Rush University Medical Center | Chicago | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| Rush University Medical Center | GlaxoSmithKline |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | Histamine Content in the Tears Was Measured. | Tear samples were assayed for histamine by ELISA | Samples taken at initial visit & 2 week follow-up | No |