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

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Status and phase

Completed
Phase 4

Conditions

Allergic Conjunctivitis to Tree Pollen or Grass Pollen

Treatments

Drug: Fluticasone furoate nasal spray
Drug: Placebo nasal spray

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00891436
RUMCgsk 113002

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

20 participants in 2 patient groups, including a placebo group

Placebo nasal spray
Placebo Comparator group
Treatment:
Drug: Placebo nasal spray
Fluticasone furoate nasal spray
Active Comparator group
Treatment:
Drug: Fluticasone furoate nasal spray

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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