Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-02-26 @ 6:53 AM
Study NCT ID:
NCT01128556
Status:
COMPLETED
Last Update Posted:
2010-07-08
First Post:
2010-05-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Evaluation of Bepreve on the Measurement of Wheal and Flare Response From Histamine Skin Prick Testing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003233', 'term': 'Conjunctivitis, Allergic'}], 'ancestors': [{'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C511534', 'term': 'bepotastine besilate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-07', 'studyFirstSubmitDate': '2010-05-21', 'studyFirstSubmitQcDate': '2010-05-21', 'lastUpdatePostDateStruct': {'date': '2010-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measurement of Wheal and Flare response from histamine skin-prick testing', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['allergic conjunctivitis', 'histamine skin testing'], 'conditions': ['Histamine Responsive Allergy Patients']}, 'descriptionModule': {'briefSummary': 'To evaluate the effect of BEPREVE compared to a REFRESH Tears Lubricant eye drop on the measurement of the wheal and flare from histamine skin prick testing. This is an open label, two-week, post-marketing study conducted on histamine responsive patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and female subjects, 18 to 65 years of age\n* Patients must demonstrate a positive reaction to a Histamine skin-prick test. Manifested by a histamine-induced wheal of \\>3mm in diameter over the normal saline control after 15 minutes of elapsed time\n\nExclusion Criteria:\n\n* Significant signs and symptoms of currently active allergic disease (SAR, perennial allergic rhinitis, episodic allergic rhinitis)\n* Upper respiratory tract infection, sinusitis, asthma or flu-like symptoms within 2 weeks prior to visit 1\n* Subjects who have dermatographism or other skin conditions which might interfere with the interpretation of the skin test results\n* Subjects who are receiving escalating doses of immunotherapy, oral immunotherapy or short course (rush) immunotherapy\n* Known hypersensitivity to the investigational product or to drugs with similar chemical properties\n* Pregnancy and/or breast feeding\n* Use of antihistamines, NSAIDS, steroids, or other drugs which may affect the skin-response\n* Use of any medications or agents that are not specified above that may confound the interpretation of the results'}, 'identificationModule': {'nctId': 'NCT01128556', 'briefTitle': 'The Evaluation of Bepreve on the Measurement of Wheal and Flare Response From Histamine Skin Prick Testing', 'organization': {'class': 'OTHER', 'fullName': 'North Texas Institute for Clinical Trials'}, 'officialTitle': 'The Evaluation of the Effect of Bepreve, a Topical Ocular Antihistamine, on the Measurement of Wheal and Flare Response From Histamine Skin Prick Testing', 'orgStudyIdInfo': {'id': 'MAC-01-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bepreve', 'description': 'topical ocular treatment as indicated', 'interventionNames': ['Drug: Bepreve', 'Drug: Refresh Tears']}], 'interventions': [{'name': 'Bepreve', 'type': 'DRUG', 'otherNames': ['bepotastine besilate'], 'description': 'Bepreve (bepotastine besilate ophthalmic solution 1.5%) one drop in each eye twice daily', 'armGroupLabels': ['Bepreve']}, {'name': 'Refresh Tears', 'type': 'DRUG', 'description': 'Refresh Tears one drop to each eye twice daily for 7 days after the conclusion of Bepreve treatment', 'armGroupLabels': ['Bepreve']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76132', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'North Texas Institute for Clinical Trials', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}], 'overallOfficials': [{'name': 'Bob Q Lanier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'North Texas Institute for Clinical Trials'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'North Texas Institute for Clinical Trials', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Bob Q. Lanier, M.D.', 'oldOrganization': 'North Texas Institute for Clinical Trials'}}}}