Conjunctival Allergen Challenge (CAC) Following Allergen Exposure in the Allergen BioCube (ABC)

Completed

• Conditions: Allergic Rhinoconjunctivitis

• Registration Number: NCT00985296
• Lead Sponsor: ORA, Inc.

Brief Summary

To evaluate the effect of Conjunctival Allergen Challenge (CAC) with Dust Mites on nasal and ocular allergic symptoms following allergen exposure in the Allergen BioCube (ABC).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-25
• Study First Submitted QC: 2009-09-25
• Study First Posted: 2009-09-28
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-20
• Last Update Posted: 2010-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• be at least 18 years of age;
• if female, cannot be pregnant or nursing;
• have a history of ocular and nasal allergy;
• have a positive skin test reaction to ragweed within the past 24 months;
• may/may not have a positive skin test reaction to dust mites 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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ocular Itching	At specified timepoints for up to 2 hours
Conjunctival Redness	At specified timepoints for up to 2 hours
Total Ocular Symptom Score (TOSS) of ocular itching and redness	At specified timepoints for up to 2 hours
Total Nasal Symptom Score (TNSS) of nasal symptoms	At specified timepoints for up to 2 hours
Nasal itching, Sneezing, Rhinorrhea, and Nasal Congestion	At specified timepoints for up to 2 hours

Secondary Outcome Measures

Name	Time	Method
Ciliary and episcleral redness	At specified timepoints for up to 2 hours
Chemosis	At specified timepoints for up to 2 hours
Lid Swelling	At specified timepoints for up to 2 hours

Trial Locations

Locations (1)

ORA, Inc.; 🇺🇸 Andover, Massachusetts, United States