A Pilot Study Evaluating the Signs and Symptoms of Seasonal Allergic Rhinoconjunctivitis Following Exposure in the Allergen BioCube
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ClinicalTrials.gov Identifier: NCT00985075 |
Recruitment Status
:
Completed
First Posted
: September 28, 2009
Last Update Posted
: September 28, 2009
|
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Condition or disease |
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Allergic Rhinoconjunctivitis |
Study Type : | Observational |
Estimated Enrollment : | 100 participants |
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 |
Study Start Date : | December 2008 |
Actual Primary Completion Date : | June 2009 |
Actual Study Completion Date : | July 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 [ Time Frame: Not Specified ]
- Total Nasal Symptom Score (TNSS) of nasal symptoms [ Time Frame: Not Specified ]
- 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 ]

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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 |
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;

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
United States, Massachusetts | |
Ophthalmic Research Associates, Inc | |
Andover, Massachusetts, United States, 01810 |
Study Director: | Paul Gomes, MS | ORA, Inc. | |
Principal Investigator: | Henry J. Crampton, MD | ORA, Inc. |
Responsible Party: | H. Jerome Crampton, MD, Ophthalmic Research Associates |
ClinicalTrials.gov Identifier: | NCT00985075 History of Changes |
Other Study ID Numbers: |
08-003-14 |
First Posted: | September 28, 2009 Key Record Dates |
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 |