Status:
COMPLETED
A Pilot Study Evaluating the Signs and Symptoms of Seasonal Allergic Rhinoconjunctivitis Following Exposure in the Allergen BioCube
Lead Sponsor:
ORA, Inc.
Conditions:
Allergic Rhinoconjunctivitis
Eligibility:
All Genders
18+ years
Brief Summary
The objective of this study is to evaluate ocular and nasal signs and symptoms in patients with seasonal allergic rhinoconjunctivitis following allergen exposure in the Allergen BioCube.
Eligibility Criteria
Inclusion
- be at least 18 years of age;
- if female, cannot be pregnant or nursing;
- have a history of ocular and nasal allergy and a positive skin test reaction to one of the allergens tested within the past 24 months;
Exclusion
- have a history of mild persistent, moderate or severe asthma within the preceding 5 years according to the National Heart, Blood and Lung Institute classification;
- have a compromised lung function;
- have any ocular condition that could affect the subject's health or the study parameters;
- have any presence of active ocular or sinus infection;
- have significant nasal conditions;
- have any significant illness that could be expected to interfere with the subject's health or with the study parameters
- use specified disallowed medications (topical, topical ophthalmic, systemic and/or injectable treatments and all anti-allergy therapies) during the study or appropriate pre-study washout period;
- have used an investigational drug or device within 30 days of starting the study or be concurrently enrolled in another investigational drug or device study within 30 days of the study;
Key Trial Info
Start Date :
December 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00985075
Start Date
December 1 2008
End Date
July 1 2009
Last Update
September 28 2009
Active Locations (1)
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1
Ophthalmic Research Associates, Inc
Andover, Massachusetts, United States, 01810