Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2026-02-03 @ 8:29 AM
Study NCT ID:
NCT00567918
Status:
COMPLETED
Last Update Posted:
2008-04-04
First Post:
2007-12-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase III, Long-Term, Open-Label, Extension Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients With Vernal Keratoconjunctivitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007637', 'term': 'Keratoconjunctivitis'}, {'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003233', 'term': 'Conjunctivitis, Allergic'}], 'ancestors': [{'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007634', 'term': 'Keratitis'}, {'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016559', 'term': 'Tacrolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-04-03', 'studyFirstSubmitDate': '2007-12-03', 'studyFirstSubmitQcDate': '2007-12-03', 'lastUpdatePostDateStruct': {'date': '2008-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': 'length of study'}], 'secondaryOutcomes': [{'measure': 'The mean change from the baseline (before the treatment) in total score for objective clinical signs', 'timeFrame': 'length of study'}, {'measure': 'Mean change from the baseline in score for objective clinical signs and the score for each objective clinical sign', 'timeFrame': 'Length of study'}, {'measure': 'Subjective symptom score (Visual Analog Scale)', 'timeFrame': 'Length of study'}, {'measure': 'The improvement rate', 'timeFrame': 'Length of study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Keratoconjunctivitis', 'Vernal keratoconjunctivitis', 'FK506', 'Tacrolimus'], 'conditions': ['Keratoconjunctivitis', 'Conjunctivitis']}, 'descriptionModule': {'briefSummary': 'To investigate the long-term efficacy and safety of FK506 ophthalmic suspension in patients with vernal keratoconjunctivitis', 'detailedDescription': 'To give a chance of continuous use of 0.1% FK506 ophthalmic suspension to patients with vernal keratoconjunctivitis who were enrolled in the FJ-506D-AC09 study, long-term safety and efficacy were evaluated. Primary efficacy endpoint was the mean change from the baseline (before the treatment) in total score for objective clinical signs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Vernal keratoconjunctivitis patients who were enrolled in the FJ-506D-AC09 study\n* Patients who wish to receive continuous administration of FK506 ophthalmic suspension\n\nExclusion Criteria:\n\n* Subjects who needed prohibited concomitant therapy at the initiation of the study\n* Subjects who needed to wear contact lenses during treatment period on a testing eye\n* Subjects with complicating an eye infection'}, 'identificationModule': {'nctId': 'NCT00567918', 'briefTitle': 'Phase III, Long-Term, Open-Label, Extension Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients With Vernal Keratoconjunctivitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'Phase III, Long-Term, Open-Label, Extension Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients', 'orgStudyIdInfo': {'id': 'FJ-506D-AC10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'FK506 ophthalmic suspension', 'interventionNames': ['Drug: FK506']}], 'interventions': [{'name': 'FK506', 'type': 'DRUG', 'otherNames': ['tacrolimus'], 'description': 'Ophthalmic suspension', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ehime', 'country': 'Japan'}, {'city': 'Hokkaido', 'country': 'Japan'}, {'city': 'Kagoshima', 'country': 'Japan', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'city': 'Kochi', 'country': 'Japan', 'geoPoint': {'lat': 33.55, 'lon': 133.53333}}, {'city': 'Miyazaki', 'country': 'Japan', 'geoPoint': {'lat': 31.91667, 'lon': 131.41667}}, {'city': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Tochigi', 'country': 'Japan', 'geoPoint': {'lat': 36.38333, 'lon': 139.73333}}, {'city': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Central Contact', 'role': 'STUDY_CHAIR', 'affiliation': 'Astellas Pharma Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director', 'oldOrganization': 'Astellas Pharma Inc.'}}}}