Study of the Effect of Fluticasone Furoate Nasal Spray on Spring Allergy Eye Symptoms
Information source: Rush University Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Allergic Conjunctivitis to Tree Pollen or Grass Pollen
Intervention: Fluticasone furoate nasal spray (Drug); Placebo nasal spray (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Rush University Medical Center Official(s) and/or principal investigator(s): J. Moy, MD, Principal Investigator, Affiliation: Rush University Medical Center
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.
Clinical Details
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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Eosinophilic Cationic Protein (ECP) Levels
Secondary outcome: Histamine Content in the Tears Was Measured.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Rush University Medical Center, Chicago, Illinois 60612, United States
Additional Information
Starting date: April 2009
Last updated: November 29, 2012
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