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

NCT00985075 | Completed

• 1 other identifier: 08-003-14
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Allergic rhinitis; Allergic conjunctivitis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• ORA, Inc.: lead

Study Sites (1)

Ophthalmic Research Associates, Inc

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Conjunctivitis; Conjunctival Diseases; Eye Diseases

Study Officials

• Paul Gomes, MS

  ORA, Inc.

  STUDY DIRECTOR

• Henry J. Crampton, MD

  ORA, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 25, 2009
• First Posted: September 28, 2009
• Study Start: December 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: July 1, 2009
• Last Updated: September 28, 2009

Record last verified: 2009-09

Locations

US (1)