Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-24 @ 12:17 PM
Study NCT ID:
NCT02555761
Status:
COMPLETED
Last Update Posted:
2019-07-05
First Post:
2015-09-18
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Lastacaft® for the Prevention of Itching Associated With Allergic Conjunctivitis in Korea
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': 'C557708', 'term': 'alcaftadine'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3423}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-02', 'studyFirstSubmitDate': '2015-09-18', 'studyFirstSubmitQcDate': '2015-09-18', 'lastUpdatePostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Adverse Events', 'timeFrame': '2 Weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Conjunctivitis, Allergic']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://allerganclinicaltrials.com', 'label': 'More Information'}]}, 'descriptionModule': {'briefSummary': 'This post-marketing surveillance study will assess the safety and efficacy of Lastacaft® Opthalmic Solution 0.25% (Alcaftadine) for the prevention of itching associated with Allergic Conjunctivitis as prescribed as standard of care in clinical practice in Korea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with itching associated with Allergic Conjunctivitis prescribed Lastacaft® as standard of care in clinical practice.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Patients with itching associated with allergic conjunctivitis.\n\nExclusion Criteria:\n\n-Patients with hypersensitivity to Lastacaft® or its components.'}, 'identificationModule': {'nctId': 'NCT02555761', 'briefTitle': 'Safety and Efficacy of Lastacaft® for the Prevention of Itching Associated With Allergic Conjunctivitis in Korea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'officialTitle': 'Evaluation of the Safety and Effectiveness of Lastacaft® Ophthalmic Solution 0.25% (Alcaftadine) for the Prevention of Itching Associated With Allergic Conjunctivitis: A Postmarketing Surveillance Study in Korea', 'orgStudyIdInfo': {'id': '229666-007'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lastacaft®', 'description': 'One drop of Lastacaft® Ophthalmic Solution 0.25% (Alcaftadine) in each eye daily as prescribed as standard of care in clinical practice.', 'interventionNames': ['Drug: Alcaftadine Ophthalmic Solution 0.25%']}], 'interventions': [{'name': 'Alcaftadine Ophthalmic Solution 0.25%', 'type': 'DRUG', 'otherNames': ['Lastacaft®'], 'description': 'Alcaftadine Ophthalmic Solution 0.25% (Lastacaft®) as prescribed as standard of care in clinical practice.', 'armGroupLabels': ['Lastacaft®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47254', 'city': 'Busan', 'country': 'South Korea', 'facility': "Seo-myeon St.Mary's Hospital", 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '47254', 'city': 'Busan', 'country': 'South Korea', 'facility': 'SeoMyeon St. Eye Clinic', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '47395', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Inje University Busan Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '48064', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Soojung Eye Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '48108', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Inje University Haeundae Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '48415', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Saint Mary Bright Eye Clinic', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '48492', 'city': 'Busan', 'country': 'South Korea', 'facility': "Daeyeon St.mary's Eye Center", 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '49201', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Dong-A University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '49241', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Pusan National University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '49241', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '49247', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Barun Sungmo Eye Clinic', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'chamjoeun Ophthalmic Clinic', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '31151', 'city': 'Chungcheongnam-do', 'country': 'South Korea', 'facility': 'Soonchunhyang University Cheonan Hospital'}, {'zip': '41196', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Cheil eye hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '41931', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Keimyung University Dongsan Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '41944', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Kyoungpook national university hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '42109', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Daegu Nune Eye Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '34066', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Saebom Eye Clinic', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '34914', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Jungbuwoorieye Clinic', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '35015', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Chonnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '35209', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Clean Eye clinic', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '35234', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Eye Love Eye Center', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '35365', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Konyang University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '35015', 'city': 'Daejoen', 'country': 'South Korea', 'facility': 'Chonnam National University Hospital'}, {'zip': '35365', 'city': 'Daejoen', 'country': 'South Korea', 'facility': 'Konyang University Hospital'}, {'zip': '11695', 'city': 'Geyonggi-do', 'country': 'South Korea', 'facility': "St. Mary's Eye center"}, {'zip': '51356', 'city': 'Geyonsangnam-do', 'country': 'South Korea', 'facility': 'Eins Eye Clinic'}, {'zip': '61062', 'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Happ Eye 21', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '61478', 'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Gwang Ju Eye Clinic', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '61964', 'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Bora Eye Clinic', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '62276', 'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Bora Eye Clinic', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '10475', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Myongji Hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '10824', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Munsan Jeil Eye Clinic', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '11695', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul Shinsegae Eye Center', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '13591', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Eagle Eye Center', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '14064', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Anyang Seoul Eye Clinic', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '16849', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Noon-Sarang Eye Hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '18600', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Bright eye', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Ansan Yonsei Eye Center', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Yonsei Dream Eye Clinic', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '50621', 'city': 'Gyeongsangnam-do', 'country': 'South Korea', 'facility': "Bright Kim's Eye Clinic"}, {'zip': '51408', 'city': 'Gyeongsangnam-do', 'country': 'South Korea', 'facility': 'Fatima ophthalmology'}, {'zip': '51436', 'city': 'Gyeongsangnam-do', 'country': 'South Korea', 'facility': 'Gowoon eye clinic'}, {'zip': '48064', 'city': 'Haeundae-gu', 'country': 'South Korea', 'facility': 'Sungmo Eye Hospital'}, {'zip': '05558', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Hangil Eye Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '21388', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Hangil Eye Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '21565', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Gachon University Gil Medical Center', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '22134', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Renessance eye center', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '48064', 'city': 'Incheon', 'country': 'South Korea', 'facility': "Bupyung ST.Mary's eye clinic", 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '54921', 'city': 'Jeollabuk-do', 'country': 'South Korea', 'facility': 'Pureun Eye Center'}, {'zip': '5492', 'city': 'Jeollabuk-do', 'country': 'South Korea', 'facility': 'Pureun Eye Center'}, {'zip': '54972', 'city': 'Jeollabuk-do', 'country': 'South Korea', 'facility': 'Onuri Eye Hospital'}, {'zip': '57643', 'city': 'Jeollanam-do', 'country': 'South Korea', 'facility': 'Seoul Eye Clinic'}, {'zip': '410719', 'city': 'Kyounggi-do', 'country': 'South Korea', 'facility': 'National Health Insurance Service Ilsan Hospital'}, {'zip': '01779', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Yonsei Woori Eye Clinic', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '02538', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Gangnam ST. Mary's Eye Center", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '02622', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hplus Eye Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '02841', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03779', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Saevit Eye Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '04101', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Sinchon Yeonsei Eye Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '04427', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Central seoul eye center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '04527', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Ian Eye Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '04596', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Lee, Im-sun Eye Clinic', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '04715', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Yonsei Eye Clinic', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05558', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'See Samsung Eye Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06017', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Yoon Ho Eye Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06030', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Apgujeong Eye Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06134', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Joeunnun Vision Clinic', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06198', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Nune Eye Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06232', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'GS eye clinic', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06292', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Lee Eye Institute', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06351', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung medical center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06591', 'city': 'Seoul', 'country': 'South Korea', 'facility': "The catholic university of korea Seoul ST. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06611', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Su Yonsei Eye Clinic', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '07301', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Kim's Eye Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08058', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Bright Seoul Ophthalmology', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '137701', 'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic Unoveristy of Korea, Seoul St Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '37722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Park Chang Soo Eye Clinic', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Yan Bai', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}