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

Study Overview
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Brief Summary
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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).

Official Title
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A Pilot Study Evaluating the Effect of Conjunctival Allergen Challenge (CAC) on Nasal and Ocular Allergic Symptoms Following Allergen Exposure in the Allergen BioCube (ABC) in Subjects With Seasonal Allergic Rhinoconjunctivitis

Conditions
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Allergic Rhinoconjunctivitis

Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ragweed+ Dust Mite+ CAC w/ DM<br> | |
| Ragweed + Dust Mite + CAC w/Saline<br> | |
| Ragweed + Dust Mite - CAC<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergic rhinitis, Allergic conjunctivitis