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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00985075

Enrollment

100

Registered

2009-09-28

Start date

2008-12-31

Completion date

2009-07-31

Last updated

2009-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinoconjunctivitis

Keywords

Allergic rhinitis, Allergic conjunctivitis

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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;

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Nasal Itching	At specified timepoints for up to 3 hours
Sneezing	At specified timepoints for up to 3 hours
Ciliary and episcleral redness	At specified timepoints for up to 3 hours
Nasal Congestion	At specified timepoints for up to 3 hours
Rhinorrhea	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

Countries

United States

Outcome results