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

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ClinicalTrials.gov Identifier: NCT00985296
Recruitment Status : Completed
First Posted : September 28, 2009
Last Update Posted : September 21, 2010
Sponsor:
Information provided by:
ORA, Inc.

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).

Condition or disease
Allergic Rhinoconjunctivitis

Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: 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
Study Start Date : September 2009
Primary Completion Date : August 2010
Study Completion Date : August 2010

Group/Cohort
Ragweed+ Dust Mite+ CAC w/ DM
Ragweed + Dust Mite + CAC w/Saline
Ragweed + Dust Mite - CAC



Primary Outcome Measures :
  1. Ocular Itching [ Time Frame: At specified timepoints for up to 2 hours ]
  2. Conjunctival Redness [ Time Frame: At specified timepoints for up to 2 hours ]
  3. Total Ocular Symptom Score (TOSS) of ocular itching and redness [ Time Frame: At specified timepoints for up to 2 hours ]
  4. Total Nasal Symptom Score (TNSS) of nasal symptoms [ Time Frame: At specified timepoints for up to 2 hours ]
  5. Nasal itching, Sneezing, Rhinorrhea, and Nasal Congestion [ Time Frame: At specified timepoints for up to 2 hours ]

Secondary Outcome Measures :
  1. Ciliary and episcleral redness [ Time Frame: At specified timepoints for up to 2 hours ]
  2. Chemosis [ Time Frame: At specified timepoints for up to 2 hours ]
  3. Lid Swelling [ Time Frame: At specified timepoints for up to 2 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 ragweed within the past 24 months.
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;
  • 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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00985296


Locations
United States, Massachusetts
ORA, Inc.
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
ORA, Inc.
Investigators
Study Director: Paul Gomes, MS ORA, Inc.
Principal Investigator: Henry J. Crampton, MD ORA, Inc.

Responsible Party: H. Jerome Crampton, MD, ORA, Inc.
ClinicalTrials.gov Identifier: NCT00985296     History of Changes
Other Study ID Numbers: 09-003-24
First Posted: September 28, 2009    Key Record Dates
Last Update Posted: September 21, 2010
Last Verified: September 2010

Keywords provided by ORA, Inc.:
Allergic rhinitis
Allergic conjunctivitis

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases