Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2025-12-29 @ 11:09 PM
Study NCT ID:
NCT01306461
Status:
COMPLETED
Last Update Posted:
2012-06-08
First Post:
2011-02-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tafluprost-Timolol Fixed Dose Combination Non-Inferiority Study Against Concomitant Administrations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D005901', 'term': 'Glaucoma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013999', 'term': 'Timolol'}, {'id': 'C485333', 'term': 'tafluprost'}], 'ancestors': [{'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013830', 'term': 'Thiadiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 401}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-07', 'studyFirstSubmitDate': '2011-02-28', 'studyFirstSubmitQcDate': '2011-02-28', 'lastUpdatePostDateStruct': {'date': '2012-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in the average diurnal intra-ocular pressure (IOP) at 6 months', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in average diurnal IOP at 2 weeks, 6 weeks and 3 months', 'timeFrame': '2 weeks, 6 weeks and 3 months'}, {'measure': 'Change from baseline in timewise IOPs', 'timeFrame': '2 weeks, 6 weeks, 3 months and 6 months', 'description': 'Change from baseline in timewise IOPs (at 8:00, 10:00, 16:00) at 2 weeks, 6 weeks, 3 months and 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ocular Hypertension', 'Open-angle Glaucoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy and safety of the preservative-free fixed-dose combination of tafluprost and timolol (FDC) to concomitant administration of tafluprost and timolol.\n\nThis study will enroll patients who have ocular hypertension or glaucoma.\n\nThe study schedule includes seven visits to the study site and three stages:\n\n* washout of 5 days to 4 weeks depending on current glaucoma medication (if any)\n* 6-month study treatment period\n* 1-3 weeks post-study period'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years or more\n* A diagnosis of ocular hypertension or open-angle glaucoma\n* Meet specific IOP level at visit 1 (screening)and visit 2 (baseline)\n* Meet specific visual acuity score\n* Are willing to follow instructions\n* Have provided a written informed consent\n\nExclusion Criteria:\n\n* Females who are pregnant, nursing or planning pregnancy\n* IOP greater than 36 mmHg at any time point at screening or baseline\n* Diagnosis of angle-closure glaucoma or secondary glaucoma other than capsular or pigmentary glaucoma in either eye\n* Suspected contraindication or hypersensitivity to study medications tafluprost or timolol (e.g. asthma, low pulse) or to wash-out medication brinzolamide\n* Glaucoma filtration surgery or any other ocular surgery (including ocular laser procedures) within 6 months prior to Screening\n* Use of contact lenses at Screening or during the study\n* Presence of any abnormality or significant illness that could be expected to interfere with the patient safety or study parameters\n* Current participation in another clinical trial within the last 30 days'}, 'identificationModule': {'nctId': 'NCT01306461', 'briefTitle': 'Tafluprost-Timolol Fixed Dose Combination Non-Inferiority Study Against Concomitant Administrations', 'organization': {'class': 'INDUSTRY', 'fullName': 'Santen Oy'}, 'officialTitle': 'A Phase III, Randomized, Double-masked 6-month Trial to Compare the Efficacy and Safety of the Preservative-free Fixed-dose Combination of Tafluprost and Timolol Eye Drops to Those of Tafluprost and Timolol Eye Drops Given Concomitantly in Patients With Open Angle Glaucoma or Ocular Hypertension', 'orgStudyIdInfo': {'id': '201051'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Timolol and Tafluprost', 'description': 'Concomitant administration of preservative-free timolol and tafluprost eye drops', 'interventionNames': ['Drug: Timolol and Tafluprost']}, {'type': 'EXPERIMENTAL', 'label': 'Fixed Dose Combination of tafluprost and timolol', 'description': 'Preservative-free Fixed Dose Combination of tafluprost and timolol eye drops', 'interventionNames': ['Drug: Fixed Dose Combination of tafluprost and timolol']}], 'interventions': [{'name': 'Timolol and Tafluprost', 'type': 'DRUG', 'description': 'Preservative-free Timolol eye drops administered twice daily concomitantly with preservative-free Tafluprost eye drops administered once daily\n\nTreatment period 6 months', 'armGroupLabels': ['Timolol and Tafluprost']}, {'name': 'Fixed Dose Combination of tafluprost and timolol', 'type': 'DRUG', 'description': 'Preservative-free Fixed Dose Combination of tafluprost and timolol eye drops administered once daily.\n\nFor masking purposes also: vehicle for timolol administered twice daily\n\nTreatment period 6 months', 'armGroupLabels': ['Fixed Dose Combination of tafluprost and timolol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Debrecen', 'country': 'Hungary', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}], 'overallOfficials': [{'name': 'Auli Ropo, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Santen Oy'}, {'name': 'Clemens Vass, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University Vienna, Austria'}, {'name': 'Marieta Kostianeva, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Mulitiprofile Hospital for Active Treatment Sv.Georgi, Bulgaria'}, {'name': 'Eva Ruzickova, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vseobecna fakultni nemocnice v Praze, Czech Republic'}, {'name': 'Gábor Holló', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Semmelweis Egyetem, Hungary'}, {'name': 'Guna Laganovska, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'P. Stradina Clinical University Hospital, Latvia'}, {'name': 'Maria L. Ribeiro, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aibili-Associação p/ Investigação Biomédica e Inovação em Luz e Imagem (AIBILI), Portugal'}, {'name': 'Julián García-Feijóo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clinico San Carlos, Spain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Santen Oy', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}