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

This study has been completed.
Information provided by (Responsible Party):
James Moy, Rush University Medical Center Identifier:
First received: April 30, 2009
Last updated: November 29, 2012
Last verified: November 2012

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.

Condition Intervention Phase
Allergic Conjunctivitis to Tree Pollen or Grass Pollen
Drug: Fluticasone furoate nasal spray
Drug: Placebo nasal spray
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Eosinophilic Cationic Protein (ECP) Levels [ Time Frame: Samples taken at initial visit & 2 week follow-up ]
    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.

Secondary Outcome Measures:
  • Histamine Content in the Tears Was Measured. [ Time Frame: Samples taken at initial visit & 2 week follow-up ]
    Tear samples were assayed for histamine by ELISA

Enrollment: 20
Study Start Date: April 2009
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo nasal spray Drug: Placebo nasal spray
2 sprays each nostril every morning for 2 weeks
Active Comparator: Fluticasone furoate nasal spray Drug: Fluticasone furoate nasal spray
2 sprays each nostril every morning for 2 weeks
Other Name: Veramyst


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00891436

United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Principal Investigator: J. Moy, MD Rush University Medical Center
  More Information

Responsible Party: James Moy, MD, Rush University Medical Center Identifier: NCT00891436     History of Changes
Other Study ID Numbers: RUMCgsk 113002
Study First Received: April 30, 2009
Results First Received: September 14, 2012
Last Updated: November 29, 2012

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents processed this record on May 24, 2017