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

NCT ID: NCT00985296

Last Updated: 2010-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-08-31

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).

Detailed Description

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Conditions

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Allergic Rhinoconjunctivitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Ragweed+ Dust Mite+ CAC w/ DM

No interventions assigned to this group

Ragweed + Dust Mite + CAC w/Saline

No interventions assigned to this group

Ragweed + Dust Mite - CAC

No interventions assigned to this group

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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ORA, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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ORA, Inc.

Principal Investigators

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Paul Gomes, MS

Role: STUDY_DIRECTOR

ORA, Inc.

Henry J. Crampton, MD

Role: PRINCIPAL_INVESTIGATOR

ORA, Inc.

Locations

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ORA, Inc.

Andover, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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09-003-24

Identifier Type: -

Identifier Source: org_study_id