Phase 4
N=21
Effect of Veramyst and Olopatadine 0.2% Opthalmic Solution on Allergy Symptoms
Seasonal Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT01007253 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcome: Primary: Total Eye Symptoms Score Difference — 6; 0; 2.5; 1.5 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- PL nasal spray (Drug); fluticasone furoate (FF) (Drug); PL eye drops (Drug); olopatadine (OLO) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Eye Symptoms Score Difference |
6; 0; 2.5; 1.5 | <0.001 sig |
| SECONDARY Total Nasal Symptoms Score Difference |
17; 10; 9; 9 | 0.05 |
| SECONDARY Total Number of Sneezes |
10; 2.5; 2.5; 1.0 | 0.001 sig |
| SECONDARY Change in Histamine Level (Across Nasal Challenges) |
5.9; 0.3; 11.4; 3.4 | 0.11 |
| SECONDARY Change in Tryptase Level (Across Nasal Challenges) |
5; 0; 2; 0 | <0.001 sig |
| SECONDARY Total Number of Eosinophils |
7883; 238; 9606; 311 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Males and females between 18 and 45 years of age.
- History of grass and/or ragweed allergic rhinitis.
- Positive skin test to grass and/or ragweed antigen.
- Positive response to screening nasal challenge.
Exclusion Criteria
- Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
- Pregnant or lactating women.
- Upper respiratory infection within 14 days of study start.
- forced expiratory volume at one second (FEV1) <80% of predicted at screening for subjects with history of mild asthma.
Data sourced from ClinicalTrials.gov (NCT01007253). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.