Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2025-12-25 @ 11:53 AM
Study NCT ID:
NCT01390961
Status:
UNKNOWN
Last Update Posted:
2011-07-11
First Post:
2011-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Tolerability Between Two Allergy Drops
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': 'D009278', 'term': 'Naphazoline'}, {'id': 'D010632', 'term': 'Pheniramine'}, {'id': 'C557708', 'term': 'alcaftadine'}, {'id': 'C116502', 'term': 'Naphcon A'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2012-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-07-07', 'studyFirstSubmitDate': '2011-07-07', 'studyFirstSubmitQcDate': '2011-07-07', 'lastUpdatePostDateStruct': {'date': '2011-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tolerability', 'timeFrame': '8 weeks', 'description': 'Tolerability measured by questionnaire Visual Analog scale 1 to 100'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Allergic conjunctivitis'], 'conditions': ['Allergic Conjunctivitis']}, 'descriptionModule': {'briefSummary': 'Comfort is compared between two allergy drops'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between the ages of 18 and over inclusive.\n* Males or females\n* Patient is in generally good \\& stable overall health.\n* Patient likely to comply with study guidelines \\& study visits.\n* Informed consent signed.\n* History of allergic conjunctivitis\n* Current symptoms of allergic conjunctivitis assessed by the investigator\n\nExclusion Criteria:\n\n* Corneal refractive surgery or contact lens wear within 6 months of this study.\n* Current use of Restasis\n* Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.\n* Pregnant or lactating women.\n* Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.'}, 'identificationModule': {'nctId': 'NCT01390961', 'briefTitle': 'Comparison of Tolerability Between Two Allergy Drops', 'organization': {'class': 'INDIV', 'fullName': 'Hom, Milton M., OD, FAAO'}, 'officialTitle': 'Comparison of Tolerability Between Two Allergy Drops', 'orgStudyIdInfo': {'id': 'IIT-000256'}}, 'armsInterventionsModule': {'interventions': [{'name': 'alacaftadine and naphazoline HCl & pheniramine maleate', 'type': 'DRUG', 'otherNames': ['Lastacaft', 'Opcon A'], 'description': 'once a day'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91702', 'city': 'Azusa', 'state': 'California', 'country': 'United States', 'facility': 'Milton M. Hom, OD, FAAO.', 'geoPoint': {'lat': 34.13362, 'lon': -117.90756}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hom, Milton M., OD, FAAO', 'class': 'INDIV'}, 'collaborators': [{'name': 'Allergan', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Milton M. Hom, OD, FAAO.', 'oldOrganization': 'Private Practice'}}}}