Effect of Veramyst and Olopadatine 0.2% Opthalmic Solution on Allergy Symptoms

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Robert Naclerio, University of Chicago
ClinicalTrials.gov Identifier:
NCT01007253
First received: November 3, 2009
Last updated: June 14, 2012
Last verified: June 2012

November 3, 2009
June 14, 2012
November 2009
April 2010   (final data collection date for primary outcome measure)
the difference in change in total eye symptoms after antigen challenge [ Time Frame: duration of antigen challenge ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01007253 on ClinicalTrials.gov Archive Site
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Effect of Veramyst and Olopadatine 0.2% Opthalmic Solution on Allergy Symptoms
Effect of Veramyst and Olopadatine 0.2% Opthalmic Solution Alone and In Combination on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen.

People who have hayfever or allergic rhinitis often complain about eye symptoms associated with their nasal symptoms. How people with hayfever develop eye symptoms is not clear. The purpose of this study is to better understand the generation of eye symptoms in patients with allergic rhinitis. We have previously shown that placing the substance that subjects are allergic too in their nose causes both nose and eye symptoms. This can be explain by a parasympathetic neurogenic reflex from the nose to the eye. Such a reflex would readily explain the tearing and watery eye symptoms, but does not explain the itch. In this study, we are going to address one possible explanation for the itch; does an axonal neurogenic reflex stimulate mast cells in the eye to release histamine, which then causes the itch? We will do this by placing an antihistamine drop in the eye and challenge the nose with allergen. We will also attempt to demonstrate that mast activation isn't effected by blocking the initiating of the reflex with a nasal steroid, as done in our previous study, and showing that the addition of an antihistamine does not add to the reduction of symptoms.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Seasonal Allergic Rhinitis
  • Drug: Veramyst /Artificial tears
    2 puffs of nasal spray in each nostril once a day for 1 week; 1 drop of eye drops in each eye once a day for 1 week
  • Drug: Veramyst / Artificial tears lubricant eye drops
    2 puffs of nasal spray in each nostril once a day for 1 week; 1 drop of eye drops in each eye once a day for 1 week
  • Drug: Veramyst nasal spray and Olopatadine eye drops
    2 puffs of nasal spray in each nostril once a day for 1 week; 1 drop of eye drops in each eye once a day for 1 week
  • Other: Veramyst placebo and Olopatadine0.2% eye drops
    2 puffs of nasal spray in each nostril once a day for 1 week; 1 drop of eye drops in each eye once a day for 1 week
  • Placebo Comparator: Placebo/placebo
    1 week treatment with placebo nasal spray and placebo eyedrops prior to nasal challenge
    Intervention: Drug: Veramyst /Artificial tears
  • Veramyst nasal spray/placebo eye drops
    1 week treatment with active nasal spray and placebo eye drops prior to nasal challenge
    Intervention: Drug: Veramyst / Artificial tears lubricant eye drops
  • Placebo spray/Olopatadine eye drops
    1 week treatment with placebo nasal spray and active eye drops prior to nasal challenge
    Intervention: Other: Veramyst placebo and Olopatadine0.2% eye drops
  • Active Comparator: Veramyst /Olopatadine eye drops
    1 week treatment with active nasal spray and active eye drops prior to nasal challenge
    Intervention: Drug: Veramyst nasal spray and Olopatadine eye drops
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
August 2011
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria

  1. Males and females between 18 and 45 years of age.
  2. History of grass and/or ragweed allergic rhinitis.
  3. Positive skin test to grass and/or ragweed antigen.
  4. Positive response to screening nasal challenge.

Exclusion Criteria

  1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
  2. Pregnant or lactating women.
  3. Upper respiratory infection within 14 days of study start.
  4. FEV1<80% of predicted at screening for subjects with history of mild asthma.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01007253
09-287-B
No
Robert Naclerio, University of Chicago
University of Chicago
GlaxoSmithKline
Principal Investigator: Robert M Naclerio, MD University of Chicago
University of Chicago
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP