A Pilot Study Evaluating the Signs and Symptoms of Seasonal Allergic Rhinoconjunctivitis Following Exposure in the Allergen BioCube
Completed
- Conditions
- Allergic Rhinoconjunctivitis
- Registration Number
- NCT00985075
- Lead Sponsor
- ORA, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Ophthalmic Research Associates, Inc
🇺🇸Andover, Massachusetts, United States