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| Sponsor: | ORA, Inc. |
|---|---|
| Information provided by: | ORA, Inc. |
| ClinicalTrials.gov Identifier: | NCT00985296 |
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 |
| 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 |
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.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| ORA, Inc. | |
| Andover, Massachusetts, United States, 01810 | |
| Study Director: | Paul Gomes, MS | ORA, Inc. |
| Principal Investigator: | Henry J. Crampton, MD | ORA, Inc. |
More Information
| 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 |
|
Allergic rhinitis Allergic conjunctivitis |
|
Conjunctivitis, Allergic Conjunctivitis Conjunctival Diseases Eye Diseases |
Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |