Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2026-02-13 @ 11:03 AM
Study NCT ID:
NCT01808768
Status:
UNKNOWN
Last Update Posted:
2013-05-30
First Post:
2013-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ocular Allergy Treatment Practical Impact Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-02-04', 'releaseDate': '2013-12-13'}], 'estimatedResultsFirstSubmitDate': '2013-12-13'}}, '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': 'C557708', 'term': 'alcaftadine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2013-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-05-29', 'studyFirstSubmitDate': '2013-03-06', 'studyFirstSubmitQcDate': '2013-03-07', 'lastUpdatePostDateStruct': {'date': '2013-05-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life- Eye Allergy Patient Impact Questionnaire', 'timeFrame': '4 months'}], 'secondaryOutcomes': [{'measure': 'Ocular Surface Disease Index Pollen Count correlation of symptoms', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Allergic Conjunctivitis', 'Rhinoconjunctivitis']}, 'descriptionModule': {'briefSummary': 'To study the impact of alcaftadine in patients treated with other opthalmic ocular agents (or specific topical opthalmic treatment) in an allergy subspecialist outpatient setting.', 'detailedDescription': 'To assess the impact of ocular allergy treatment on patients using an ophthalmic agent (or no treatment) versus alcaftadine(Lastacaft™)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. patients age 18 and older with a history of seasonal or perennial forms of allergic conjunctivitis and skin test positive reactivity to seasonal aeroallergens\n2. Total Ocular Symptom Score (TOSS) on the day of enrollment of 4 or more.\n3. have allergic ocular symptoms for the past week for which they are either treating with ophthalmic agents or have had no treatment.\n4. Are willing/able to follow instructions from the study investigator and his/her study staff.\n5. Have signed infromed consent approved by Institutional Review Board or Independent Ethics Committee.\n\n \\-\n\nExclusion Criteria:\n\n1. Active ocular infection;\n2. History of retinal detachment, diabetic neuropathy, or any progressive retinal disease;\n3. Ocular surgical intervention within three (3) months prior to visit 1 or scheduled during the study.\n4. History of unstable, or uncontrolled disease of any nature.\n5. Pregnancy or lactation;\n6. Have a known hypersensitivity tp LASTACAFT™ (alcaftadine) -'}, 'identificationModule': {'nctId': 'NCT01808768', 'acronym': '(OAT-PIT)', 'briefTitle': 'Ocular Allergy Treatment Practical Impact Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Starx Research Center, LLC'}, 'officialTitle': 'To Assess the Impact of Ocular Allergy Treatment on Patients Using an Opthalmic Agent (or no Treatment) Versus Alcaftadine(Lastacaft™)', 'orgStudyIdInfo': {'id': 'ID IIT- 000373'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alcaftadine', 'description': 'subject on any ocular allergy ophthalmic treatment or no treatment will be started on Alcaftadine 0.25%(study drug)- 1 drop each eye daily for 1-2 weeks', 'interventionNames': ['Drug: Alcaftadine']}], 'interventions': [{'name': 'Alcaftadine', 'type': 'DRUG', 'otherNames': ['Lastacaft'], 'description': 'Alcaftadine 0.25% one dorp each eye daily for 1-2 weeks.', 'armGroupLabels': ['Alcaftadine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08820', 'city': 'Edison', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Erika Julca, lpn,crc', 'role': 'CONTACT', 'email': 'ejulca1@gmail.com', 'phone': '732-906-1747'}, {'name': 'June Pepe, lpn, ccrc', 'role': 'CONTACT', 'email': 'pepejune@gmail.com', 'phone': '973-912-9817'}, {'name': 'Jayesh Kanuga, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ligaya Centeno, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ruby Reyes, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Leonard Bielory, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'STARx Research Center', 'geoPoint': {'lat': 40.51872, 'lon': -74.4121}}, {'zip': '07081', 'city': 'Springfield', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Leonard Bielory, MD', 'role': 'CONTACT', 'email': 'DrLBielory@gmail.com', 'phone': '973-912-9817'}, {'name': 'Leonard Bielory, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'STARx', 'geoPoint': {'lat': 40.70491, 'lon': -74.31723}}], 'centralContacts': [{'name': 'Jayesh Kanuga, MD', 'role': 'CONTACT', 'email': 'jkanuga@gmail.com', 'phone': '732-906-1747'}, {'name': 'Erika Julca, LPN,CRC', 'role': 'CONTACT', 'email': 'ejulca1@gmail.com', 'phone': '732-906-1747'}], 'overallOfficials': [{'name': 'Jayesh Kanuga, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Starx Research Center, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Starx Research Center, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Jayesh G. Kanuga, M.D.', 'investigatorAffiliation': 'Starx Research Center, LLC'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2013-12-13', 'type': 'RELEASE'}, {'date': '2014-02-04', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Jayesh G. Kanuga, M.D., Medical Doctor, Starx Research Center, LLC'}}}}