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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00985296

Acronym

ABC CAC

Enrollment

120

Registered

2009-09-28

Start date

2009-09-30

Completion date

2010-08-31

Last updated

2010-09-21

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

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).

Interventions

None listed

Study design

Observational model

CASE_CONTROL

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; * 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;

Design outcomes

Primary

Measure	Time frame
Nasal itching, Sneezing, Rhinorrhea, and Nasal Congestion	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
Ocular Itching	At specified timepoints for up to 2 hours

Secondary

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

Countries

United States

Outcome results