Clinical trial NCT00985075: A Pilot Study Evaluating the Signs and Symptoms of Seasonal Allergic Rhinoconjunctivitis Following Exposure in the Allergen BioCube
Official title: A Pilot Study Evaluating the Signs and Symptoms of Seasonal Allergic Rhinitis and Conjunctivitis Following Allergen Exposure in the Allergen BioCube
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Rhinoconjunctivitis
Keywords: Allergic rhinitis
Allergic conjunctivitis
Lead sponsor: ORA, Inc.
Sponsor class: INDUSTRY
First posted: 2009-09-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Ocular Itching
timeFrame: At specified timepoints for up to 3 hours
measure: Conjunctival Redness
timeFrame: At specified timepoints for up to 3 hours
measure: Total Ocular Symptom Score (TOSS)of ocular itching and redness
measure: Total Nasal Symptom Score (TNSS) of nasal symptoms
Secondary outcomes:
measure: Ciliary and episcleral redness
timeFrame: At specified timepoints for up to 3 hours
measure: Chemosis
timeFrame: At specified timepoints for up to 3 hours
measure: Lid Swelling
timeFrame: At specified timepoints for up to 3 hours
measure: Tearing
timeFrame: At specified timepoints for up to 3 hours
measure: Nasal Itching
timeFrame: At specified timepoints for up to 3 hours
measure: Sneezing
timeFrame: At specified timepoints for up to 3 hours
measure: Rhinorrhea
timeFrame: At specified timepoints for up to 3 hours
measure: Nasal Congestion
timeFrame: At specified timepoints for up to 3 hours
Other outcomes:
Locations:
city: Andover
country: United States
facility: Ophthalmic Research Associates, Inc
state: Massachusetts
Study officials:
affiliation: ORA, Inc.
name: Paul Gomes, MS
role: STUDY_DIRECTOR
affiliation: ORA, Inc.
name: Henry J. Crampton, MD
role: PRINCIPAL_INVESTIGATOR
References: