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

This study has been completed.
Sponsor:
Information provided by:
ORA, Inc.
ClinicalTrials.gov Identifier:
NCT00985075
First received: September 25, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  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 ] [ Designated as safety issue: No ]
  • Conjunctival Redness [ Time Frame: At specified timepoints for up to 3 hours ] [ Designated as safety issue: No ]
  • Total Ocular Symptom Score (TOSS)of ocular itching and redness [ Time Frame: Not Specified ] [ Designated as safety issue: No ]
  • Total Nasal Symptom Score (TNSS) of nasal symptoms [ Time Frame: Not Specified ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ciliary and episcleral redness [ Time Frame: At specified timepoints for up to 3 hours ] [ Designated as safety issue: No ]
  • Chemosis [ Time Frame: At specified timepoints for up to 3 hours ] [ Designated as safety issue: No ]
  • Lid Swelling [ Time Frame: At specified timepoints for up to 3 hours ] [ Designated as safety issue: No ]
  • Tearing [ Time Frame: At specified timepoints for up to 3 hours ] [ Designated as safety issue: No ]
  • Nasal Itching [ Time Frame: At specified timepoints for up to 3 hours ] [ Designated as safety issue: No ]
  • Sneezing [ Time Frame: At specified timepoints for up to 3 hours ] [ Designated as safety issue: No ]
  • Rhinorrhea [ Time Frame: At specified timepoints for up to 3 hours ] [ Designated as safety issue: No ]
  • Nasal Congestion [ Time Frame: At specified timepoints for up to 3 hours ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: H. Jerome Crampton, MD, Ophthalmic Research Associates
ClinicalTrials.gov Identifier: NCT00985075     History of Changes
Other Study ID Numbers: 08-003-14
Study First Received: September 25, 2009
Last Updated: September 25, 2009
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 22, 2014