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

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

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.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinoconjunctivitis

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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;

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ocular Itching	At specified timepoints for up to 3 hours
Conjunctival Redness	At specified timepoints for up to 3 hours
Total Ocular Symptom Score (TOSS)of ocular itching and redness
Total Nasal Symptom Score (TNSS) of nasal symptoms

Secondary Outcome Measures

Outcome Measure	Time Frame
Ciliary and episcleral redness	At specified timepoints for up to 3 hours
Chemosis	At specified timepoints for up to 3 hours
Lid Swelling	At specified timepoints for up to 3 hours
Tearing	At specified timepoints for up to 3 hours
Nasal Itching	At specified timepoints for up to 3 hours
Sneezing	At specified timepoints for up to 3 hours
Rhinorrhea	At specified timepoints for up to 3 hours
Nasal Congestion	At specified timepoints for up to 3 hours

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: September 25, 2009
• First Submitted That Met QC Criteria: September 25, 2009
• First Posted (Estimate): September 28, 2009

Study Record Updates

• Last Update Posted (Estimate): September 28, 2009
• Last Update Submitted That Met QC Criteria: September 25, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Allergic conjunctivitis; Allergic rhinitis
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctival Diseases; Conjunctivitis; Conjunctivitis, Allergic
• Other Study ID Numbers: 08-003-14