Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT00721656
Status:
COMPLETED
Last Update Posted:
2009-03-18
First Post:
2008-07-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 2 Study of KLS-0611 in Patients With Dry Eye Syndromes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'lastUpdateSubmitDate': '2009-03-16', 'studyFirstSubmitDate': '2008-07-22', 'studyFirstSubmitQcDate': '2008-07-23', 'lastUpdatePostDateStruct': {'date': '2009-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Corneal-conjunctival staining', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dry eye syndromes', 'Corneal diseases', 'Conjunctival Diseases'], 'conditions': ['Dry Eye Syndromes']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of KLS-0611 compared to placebo in patients with dry eye syndromes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Corneal and conjunctival damage\n* Insufficiency of lacrimal secretion\n* Ocular symptom\n\nExclusion Criteria:\n\n* Severe ophthalmic disorder\n* Punctual plugs or surgery for occlusion of the lacrimal puncta'}, 'identificationModule': {'nctId': 'NCT00721656', 'briefTitle': 'Phase 2 Study of KLS-0611 in Patients With Dry Eye Syndromes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kissei Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Randomized, Double Blind, Placebo Controlled, Phase 2 Study of KLS-0611 in Patients With Dry Eye Syndromes', 'orgStudyIdInfo': {'id': 'KLS1201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'KLS-0611', 'interventionNames': ['Drug: KLS-0611']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}, {'name': 'KLS-0611', 'type': 'DRUG', 'armGroupLabels': ['KLS-0611']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hokkaido Region', 'country': 'Japan', 'facility': 'Japan'}, {'city': 'Kansai Region', 'country': 'Japan', 'facility': 'Japan'}, {'city': 'Kanto Region', 'country': 'Japan', 'facility': 'Japan'}, {'city': 'Kyushu Region', 'country': 'Japan', 'facility': 'Japan'}, {'city': 'Shikoku Region', 'country': 'Japan', 'facility': 'Japan'}], 'overallOfficials': [{'name': 'Yasuhiro Omori', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kissei Pharmaceutical Co., Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kissei Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}}}}