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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00985075
First Posted: September 28, 2009
Last Update Posted: September 28, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
ORA, Inc.
  Purpose
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.

Condition
Allergic Rhinoconjunctivitis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Pilot Study Evaluating the Signs and Symptoms of Seasonal Allergic Rhinitis and Conjunctivitis Following Allergen Exposure in the Allergen BioCube

Resource links provided by NLM:


Further study details as provided by ORA, Inc.:

Primary Outcome Measures:
  • Ocular Itching [ Time Frame: At specified timepoints for up to 3 hours ]
  • Conjunctival Redness [ Time Frame: At specified timepoints for up to 3 hours ]
  • Total Ocular Symptom Score (TOSS)of ocular itching and redness [ Time Frame: Not Specified ]
  • Total Nasal Symptom Score (TNSS) of nasal symptoms [ Time Frame: Not Specified ]

Secondary Outcome Measures:
  • Ciliary and episcleral redness [ Time Frame: At specified timepoints for up to 3 hours ]
  • Chemosis [ Time Frame: At specified timepoints for up to 3 hours ]
  • Lid Swelling [ Time Frame: At specified timepoints for up to 3 hours ]
  • Tearing [ Time Frame: At specified timepoints for up to 3 hours ]
  • Nasal Itching [ Time Frame: At specified timepoints for up to 3 hours ]
  • Sneezing [ Time Frame: At specified timepoints for up to 3 hours ]
  • Rhinorrhea [ Time Frame: At specified timepoints for up to 3 hours ]
  • Nasal Congestion [ Time Frame: At specified timepoints for up to 3 hours ]

Estimated Enrollment: 100
Study Start Date: December 2008
Study Completion Date: July 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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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 one of the allergens tested 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 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;
  Contacts and Locations
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): NCT00985075


Locations
United States, Massachusetts
Ophthalmic Research Associates, 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.
  More Information

Responsible Party: H. Jerome Crampton, MD, Ophthalmic Research Associates
ClinicalTrials.gov Identifier: NCT00985075     History of Changes
Other Study ID Numbers: 08-003-14
First Submitted: September 25, 2009
First Posted: September 28, 2009
Last Update Posted: September 28, 2009
Last Verified: September 2009

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

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