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

NCT ID: NCT00985075

Last Updated: 2009-09-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-07-31

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.

Conditions

Allergic Rhinoconjunctivitis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility 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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ORA, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Ophthalmic Research Associates

Principal Investigators

Paul Gomes, MS

Role: STUDY_DIRECTOR

ORA, Inc.

Henry J. Crampton, MD

Role: PRINCIPAL_INVESTIGATOR

ORA, Inc.

Locations

Ophthalmic Research Associates, Inc

Andover, Massachusetts, United States

Countries

United States

Other Identifiers

08-003-14

Identifier Type: -

Identifier Source: org_study_id