A Pilot Study Evaluating the Signs and Symptoms of Seasonal Allergic Rhinoconjunctivitis Following Exposure in the Allergen BioCube

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease
Allergic Rhinoconjunctivitis

Study Design

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Study Type :	Observational
Estimated Enrollment :	100 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Official Title:	A Pilot Study Evaluating the Signs and Symptoms of Seasonal Allergic Rhinitis and Conjunctivitis Following Allergen Exposure in the Allergen BioCube
Study Start Date :	December 2008
Actual Primary Completion Date :	June 2009
Actual Study Completion Date :	July 2009

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Ocular Itching [ Time Frame: At specified timepoints for up to 3 hours ]
2. Conjunctival Redness [ Time Frame: At specified timepoints for up to 3 hours ]
3. Total Ocular Symptom Score (TOSS)of ocular itching and redness [ Time Frame: Not Specified ]
4. Total Nasal Symptom Score (TNSS) of nasal symptoms [ Time Frame: Not Specified ]

Secondary Outcome Measures :

1. Ciliary and episcleral redness [ Time Frame: At specified timepoints for up to 3 hours ]
2. Chemosis [ Time Frame: At specified timepoints for up to 3 hours ]
3. Lid Swelling [ Time Frame: At specified timepoints for up to 3 hours ]
4. Tearing [ Time Frame: At specified timepoints for up to 3 hours ]
5. Nasal Itching [ Time Frame: At specified timepoints for up to 3 hours ]
6. Sneezing [ Time Frame: At specified timepoints for up to 3 hours ]
7. Rhinorrhea [ Time Frame: At specified timepoints for up to 3 hours ]
8. Nasal Congestion [ Time Frame: At specified timepoints for up to 3 hours ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Subjects will be 18 years of age or older with a positive history of ocular and nasal allergy and a positive skin test reaction to one of the allergens tested within the past 24 months

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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;

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Massachusetts
Ophthalmic Research Associates, Inc
Andover, Massachusetts, United States, 01810

Sponsors and Collaborators

ORA, Inc.

Investigators

Study Director:	Paul Gomes, MS	ORA, Inc.
Principal Investigator:	Henry J. Crampton, MD	ORA, Inc.

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	H. Jerome Crampton, MD, Ophthalmic Research Associates
ClinicalTrials.gov Identifier:	NCT00985075 History of Changes
Other Study ID Numbers:	08-003-14
First Posted:	September 28, 2009
Last Update Posted:	September 28, 2009
Last Verified:	September 2009

Keywords provided by ORA, Inc.:

Allergic rhinitis; Allergic conjunctivitis

Additional relevant MeSH terms:

Conjunctivitis; Signs and Symptoms; Conjunctivitis, Allergic; Conjunctival Diseases	Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases