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

NCT01007253 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2013-07-17

Study results available
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Summary

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 to 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.

Conditions

  • Seasonal Allergic Rhinitis

Interventions

DRUG

PL nasal spray

2 puffs of PL nasal spray (from GlaxoSmithKline) in each nostril once a day for 1 week

DRUG

fluticasone furoate (FF)

2 puffs of FF nasal spray in each nostril once a day for 1 week

DRUG

PL eye drops

1 drop of placebo eye drops (lubricant eye drops with active ingredients 0.3% glycerin) in each eye once a day for 1 week

DRUG

olopatadine (OLO)

1 drop of OLO eye drops in each eye once a day for 1 week

Sponsors & Collaborators

Principal Investigators

  • Robert M Naclerio, MD · University of Chicago

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-04-30
Completion
2011-08-31

Countries

  • United States

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01007253 on ClinicalTrials.gov