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

This study has been completed.
Sponsor:
Information provided by:
ORA, Inc.
ClinicalTrials.gov Identifier:
NCT00985296
First received: September 25, 2009
Last updated: September 20, 2010
Last verified: September 2010
  Purpose

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
Allergic Rhinoconjunctivitis

Study Type: Observational
Study Design: 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

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 2 hours ] [ Designated as safety issue: No ]
  • Conjunctival Redness [ Time Frame: At specified timepoints for up to 2 hours ] [ Designated as safety issue: No ]
  • Total Ocular Symptom Score (TOSS) of ocular itching and redness [ Time Frame: At specified timepoints for up to 2 hours ] [ Designated as safety issue: No ]
  • Total Nasal Symptom Score (TNSS) of nasal symptoms [ Time Frame: At specified timepoints for up to 2 hours ] [ Designated as safety issue: No ]
  • Nasal itching, Sneezing, Rhinorrhea, and Nasal Congestion [ Time Frame: At specified timepoints for up to 2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ciliary and episcleral redness [ Time Frame: At specified timepoints for up to 2 hours ] [ Designated as safety issue: No ]
  • Chemosis [ Time Frame: At specified timepoints for up to 2 hours ] [ Designated as safety issue: No ]
  • Lid Swelling [ Time Frame: At specified timepoints for up to 2 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: September 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Ragweed+ Dust Mite+ CAC w/ DM
Ragweed + Dust Mite + CAC w/Saline
Ragweed + Dust Mite - CAC

  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 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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

Responsible Party: H. Jerome Crampton, MD, ORA, Inc.
ClinicalTrials.gov Identifier: NCT00985296     History of Changes
Other Study ID Numbers: 09-003-24
Study First Received: September 25, 2009
Last Updated: September 20, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 17, 2014