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

Allergic Rhinoconjunctivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00985075
• Other study ID #: 08-003-14
• Status: Completed
• Phase: N/A
• First received: September 25, 2009
• Last updated: September 25, 2009
• Start date: December 2008
• Est. completion date: July 2009

Study information

• Verified date: September 2009
• Source: ORA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Allergic Rhinoconjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic
• Signs and Symptoms

Locations

Country	Name	City	State
United States	Ophthalmic Research Associates, Inc	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
ORA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Itching		At specified timepoints for up to 3 hours	No
Primary	Conjunctival Redness		At specified timepoints for up to 3 hours	No
Primary	Total Ocular Symptom Score (TOSS)of ocular itching and redness		Not Specified	No
Primary	Total Nasal Symptom Score (TNSS) of nasal symptoms		Not Specified	No
Secondary	Ciliary and episcleral redness		At specified timepoints for up to 3 hours	No
Secondary	Chemosis		At specified timepoints for up to 3 hours	No
Secondary	Lid Swelling		At specified timepoints for up to 3 hours	No
Secondary	Tearing		At specified timepoints for up to 3 hours	No
Secondary	Nasal Itching		At specified timepoints for up to 3 hours	No
Secondary	Sneezing		At specified timepoints for up to 3 hours	No
Secondary	Rhinorrhea		At specified timepoints for up to 3 hours	No
Secondary	Nasal Congestion		At specified timepoints for up to 3 hours	No