Clinical trial NCT00891436: Study of the Effect of Fluticasone Furoate Nasal Spray on Spring Allergy Eye Symptoms
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Conjunctivitis to Tree Pollen or Grass Pollen
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2009-05-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Eosinophilic Cationic Protein (ECP) Levels
timeFrame: Samples taken at initial visit & 2 week follow-up
Secondary outcomes:
measure: Histamine Content in the Tears Was Measured.
timeFrame: Samples taken at initial visit & 2 week follow-up
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: J. Moy, MD
role: PRINCIPAL_INVESTIGATOR
References: