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

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.
 
ClinicalTrials.gov Identifier: NCT00985075
Recruitment Status : Completed
First Posted : September 28, 2009
Last Update Posted : September 28, 2009
Sponsor:
Information provided by:
ORA, Inc.

Tracking Information
First Submitted Date September 25, 2009
First Posted Date September 28, 2009
Last Update Posted Date September 28, 2009
Study Start Date December 2008
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 25, 2009)
  • 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
  • Total Nasal Symptom Score (TNSS) of nasal symptoms
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 25, 2009)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Pilot Study Evaluating the Signs and Symptoms of Seasonal Allergic Rhinoconjunctivitis Following Exposure in the Allergen BioCube
Official Title A Pilot Study Evaluating the Signs and Symptoms of Seasonal Allergic Rhinitis and Conjunctivitis Following Allergen Exposure in the Allergen BioCube
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Allergic Rhinoconjunctivitis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: September 25, 2009)
100
Original Estimated Enrollment Same as current
Actual Study Completion Date July 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility 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;
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00985075
Other Study ID Numbers 08-003-14
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party H. Jerome Crampton, MD, Ophthalmic Research Associates
Study Sponsor ORA, Inc.
Collaborators Not Provided
Investigators
Study Director: Paul Gomes, MS ORA, Inc.
Principal Investigator: Henry J. Crampton, MD ORA, Inc.
PRS Account ORA, Inc.
Verification Date September 2009