Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT01211951
Status:
COMPLETED
Last Update Posted:
2011-07-04
First Post:
2010-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of KCT-0809 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': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'lastUpdateSubmitDate': '2011-06-30', 'studyFirstSubmitDate': '2010-09-26', 'studyFirstSubmitQcDate': '2010-09-29', 'lastUpdatePostDateStruct': {'date': '2011-07-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Corneal-conjunctival staining scores', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dry eye syndromes', 'Corneal diseases', 'Conjunctival diseases'], 'conditions': ['Dry Eye Syndromes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of KCT-0809 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 or tear film instability\n* Ocular symptom\n\nExclusion Criteria:\n\n* Severe ophthalmic disorder\n* Punctual plugs or surgery for occlusion of the lacrimal puncta'}, 'identificationModule': {'nctId': 'NCT01211951', 'briefTitle': 'A Study of KCT-0809 in Patients With Dry Eye Syndromes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kissei Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Randomized, Double Blind, Placebo Controlled, Exploratory Phase II Study of KCT-0809 in Patients With Dry Eye Syndromes', 'orgStudyIdInfo': {'id': 'KCT1201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KCT-0809 ophthalmic solution, low dose', 'interventionNames': ['Drug: KCT-0809']}, {'type': 'EXPERIMENTAL', 'label': 'KCT-0809 ophthalmic solution, medium dose', 'interventionNames': ['Drug: KCT-0809']}, {'type': 'EXPERIMENTAL', 'label': 'KCT-0809 ophthalmic solution, high dose', 'interventionNames': ['Drug: KCT-0809']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'KCT-0809', 'type': 'DRUG', 'armGroupLabels': ['KCT-0809 ophthalmic solution, low dose']}, {'name': 'KCT-0809', 'type': 'DRUG', 'armGroupLabels': ['KCT-0809 ophthalmic solution, medium dose']}, {'name': 'KCT-0809', 'type': 'DRUG', 'armGroupLabels': ['KCT-0809 ophthalmic solution, high dose']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tohoku, Kanto, Chubu, Kansai, Kyushu Region', 'country': 'Japan', 'facility': 'Japan'}], 'overallOfficials': [{'name': 'Katsumi Hontani', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kissei Pharmaceutical Co., Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kissei Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}}}}