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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Seasonal Allergic Rhinitis
 Drug: Veramyst /Artificial tears
Drug: Veramyst / Artificial tears lubricant eye drops
Drug: Veramyst nasal spray and Olopatadine eye drops
Other: Veramyst placebo and Olopatadine0.2% eye drops
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • the difference in change in total eye symptoms after antigen challenge [ Time Frame: duration of antigen challenge ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: November 2009
Study Completion Date: August 2011
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo/placebo
1 week treatment with placebo nasal spray and placebo eyedrops prior to nasal challenge
 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
Veramyst nasal spray/placebo eye drops
1 week treatment with active nasal spray and placebo eye drops prior to nasal challenge
 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
Placebo spray/Olopatadine eye drops
1 week treatment with placebo nasal spray and active eye drops prior to nasal challenge
 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
Active Comparator: Veramyst /Olopatadine eye drops
1 week treatment with active nasal spray and active eye drops prior to nasal challenge
 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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01007253

Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
GlaxoSmithKline
Investigators
Principal Investigator: Robert M Naclerio, MD University of Chicago
  More Information

No publications provided

Responsible Party: Robert Naclerio, MD, University of Chicago
ClinicalTrials.gov Identifier: NCT01007253     History of Changes
Other Study ID Numbers: 09-287-B
Study First Received: November 3, 2009
Last Updated: June 14, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Tetrahydrozoline
Fluticasone
Olopatadine
Nasal Decongestants
Vasoconstrictor Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Bronchodilator Agents
Anti-Asthmatic Agents
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists

ClinicalTrials.gov processed this record on June 17, 2013