Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-29 @ 3:05 PM
Study NCT ID:
NCT01292460
Status:
COMPLETED
Last Update Posted:
2013-03-13
First Post:
2011-02-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tafluprost-Timolol Preservative-free Fixed Dose Combination (FDC) Superiority Study Against Monotherapies
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': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-12', 'studyFirstSubmitDate': '2011-02-08', 'studyFirstSubmitQcDate': '2011-02-08', 'lastUpdatePostDateStruct': {'date': '2013-03-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in the average diurnal Intraocular Pressure (IOP) at 3 months', 'timeFrame': 'At 3 months'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in average diurnal IOP', 'timeFrame': 'At 2 and 6 weeks and 6 months', 'description': 'Change from baseline in the average diurnal IOP at 2 weeks, 6 weeks and 6 months'}, {'measure': 'Change from baseline in timewise IOPs', 'timeFrame': 'At 2 weeks, 6 weeks, 3 months and 6 months', 'description': 'Change from baseline in timewise IOPs (at 8:00, 10:00, 16:00, 20:00)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ocular Hypertension', 'Open-angle Glaucoma']}, 'referencesModule': {'references': [{'pmid': '25447269', 'type': 'DERIVED', 'citation': 'Pfeiffer N, Traverso CE, Lorenz K, Saarela V, Liinamaa J, Uusitalo H, Astakhov Y, Boiko E, Ropo A; Preservative-free Tafluprost/Timolol Fixed Combination Study Group. A 6-month study comparing efficacy, safety, and tolerability of the preservative-free fixed combination of tafluprost 0.0015% and timolol 0.5% versus each of its individual preservative-free components. Adv Ther. 2014 Dec;31(12):1228-46. doi: 10.1007/s12325-014-0163-3. Epub 2014 Dec 2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy and safety of the preservative-free fixed tafluprost-timolol combination to those of tafluprost and timolol alone. This study will enroll patients who have ocular hypertension or glaucoma and who are using timolol or prostaglandin.\n\nThe study medication period is 6 months, but the primary evaluation of efficacy is done at 3 months.'}, '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 and prior use of timolol or prostaglandin.\n* Meet specific IOP level at visit 1 (screening), visit 2 (run-in) and visit 3 (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 of 35 mmHg or greater\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': 'NCT01292460', 'briefTitle': 'Tafluprost-Timolol Preservative-free Fixed Dose Combination (FDC) Superiority Study Against Monotherapies', '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 Given Individually in Patients With Open Angle Glaucoma or Ocular Hypertension', 'orgStudyIdInfo': {'id': '201050'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Preservative-free timolol', 'interventionNames': ['Drug: Timolol/ FDC/ Placebo/ Tafluprost']}, {'type': 'EXPERIMENTAL', 'label': 'Preservative-free FDC and placebo', 'interventionNames': ['Drug: Timolol/ FDC/ Placebo/ Tafluprost']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Preservative-free tafluprost', 'interventionNames': ['Drug: Timolol/ FDC/ Placebo/ Tafluprost']}, {'type': 'EXPERIMENTAL', 'label': 'Preservative-free FDC', 'interventionNames': ['Drug: Timolol/ FDC/ Placebo/ Tafluprost']}], 'interventions': [{'name': 'Timolol/ FDC/ Placebo/ Tafluprost', 'type': 'DRUG', 'description': 'Prior timolol users: Timolol (administered at 08:00 and 20:00) or FDC of tafluprost and timolol (at 08:00) and Placebo eye drops (at 20:00).\n\nPrior prostaglandin users: Tafluprost (administered at 08:00) or FDC of tafluprost and timolol (administered at 08:00).', 'armGroupLabels': ['Preservative-free FDC', 'Preservative-free FDC and placebo', 'Preservative-free tafluprost', 'Preservative-free timolol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70210', 'city': 'Kuopio', 'country': 'Finland', 'facility': 'Eye clinic, University Hospital of Kuopio', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'zip': '90029 OYS', 'city': 'Oulu', 'country': 'Finland', 'facility': 'Eye Clinic, University Hospital of Oulu', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}], 'overallOfficials': [{'name': 'Auli Ropo, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Santen Oy'}, {'name': 'Hannu Uusitalo, M.D., Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tampere University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Santen Oy', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}