Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-03-02 @ 3:45 PM
Study NCT ID:
NCT02471105
Status:
UNKNOWN
Last Update Posted:
2016-05-12
First Post:
2015-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-02-01', 'releaseDate': '2023-05-26'}], 'estimatedResultsFirstSubmitDate': '2023-05-26'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C485333', 'term': 'tafluprost'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 67}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-11', 'studyFirstSubmitDate': '2015-03-31', 'studyFirstSubmitQcDate': '2015-06-12', 'lastUpdatePostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the difference in mean IOP values between the 2 groups', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'the difference in IOP values between the groups in change from baseline IOP', 'timeFrame': 'month 3 and month 6'}, {'measure': 'the difference in mean IOP between the 2 groups', 'timeFrame': 'month 3'}, {'measure': 'the difference in IOP between the 2 groups at each timepoints', 'timeFrame': 'month 3 and month 6'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ocular Hypertension', 'Glaucoma']}, 'referencesModule': {'references': [{'pmid': '33818170', 'type': 'DERIVED', 'citation': 'Lemmens S, Rossetti L, Oddone F, Sunaric-Megevand G, Hommer A, Vandewalle E, Francesca Cordeiro M, McNaught A, Montesano G, Stalmans I. Comparison of preserved bimatoprost 0.01% with preservative-free tafluprost: A randomised, investigator-masked, 3-month crossover, multicentre trial, SPORT II. Eur J Ophthalmol. 2021 Apr 5:11206721211006573. doi: 10.1177/11206721211006573. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'This cross-over study will investigate the efficacy and safety of BIMMD and TUDPF in a clinical setting.', 'detailedDescription': '* A prospective, randomized, investigator-masked, crossover comparison;\n* Ocular hypertension or glaucoma (XFG or POAG) patients and who consent to participate will be enrolled in this study\n* Patients will be scheduled for a screening visit IOP assessment (IOP measurements at 08:30, 12:30 and 16:30 (±1 hour).\n* Patients who are on therapy at the screening visit and who consent to participate will undergo a washout period for 4 weeks (depending on therapy) before the baseline visit;\n* Patient can under the washout period be given brinzolamide (Azopt) if needed, Azopt should then be discontinued 5 days before baseline visit;\n* After the screening visit (and after wash-outperiod for treated patients) patients will be scheduled to undergo a baseline visit IOP assessment (IOP measurements at 08:30, 12:30 and 16:30 (± 1 hour with a minimum of 3 hours between readings) and will then be randomized for Period 1 to receive either BIMMD drops once in the evening (20:30) or TUDPF drops once in the evening (20:30) for 3 month\n* After 3 month, patients will be switched for Period 2, to the opposite treatment (e.g. switched to either BIMMD or TUDPF) to be dosed in the evening;\n* After another 3 months they will undergo the final evaluation of IOP levels and of tolerability;\n* Intermediate safety visits may be scheduled at the discretion of the investigator.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A patient suffering from ocular hypertension, XFG or POAG and needs treatment in both eyes\n* Patient is at least 18 years\n* Patient is able and willing to participate in the study for the whole duration of the follow up and is willing to sign the consent form.\n\nExclusion Criteria:\n\n* Unwilling to sign informed consent;\n* Younger than 18 years old;\n* Ocular condition that are of safety concern and that can interfere with the study results;\n* Visual field defects with an MD value above -15dB on either eye on Humphrey (or the equivalent in Octopus) and/or threatening fixation\n* Contact lens wearer;\n* Closed/barely open anterior chamber angles or history of acute angle closure on either eye as assessed by gonioscopy;\n* Ocular surgery (other than glaucoma surgery) or argon laser trabeculoplasty within the past three months on either eye;\n* Glaucoma surgery within the past 6 months on either eye;\n* Ocular inflammation/infection occurring within three months prior to pre-trial visit on either eye;\n* Concomitant topical ocular medication that can interfere with study medication on either eye;\n* Known hypersensitivity to any component of the trial drug solutions;\n* Other abnormal condition or symptom preventing the patient from entering the trial, according to the Investigator's judgement;\n* Refractive surgery patients at any time;\n* Women who are pregnant, are of childbearing potential and are not using adequate contraception or are nursing;\n* Inability to adhere to treatment/visit plan;\n* Have participated in any other Interventional clinical trial (i.e., requiring informed consent) involving an investigational drug within one month prior to pre-trial visit.\n* History of COPD, asthma or heart failure"}, 'identificationModule': {'nctId': 'NCT02471105', 'acronym': 'SPORTII', 'briefTitle': 'Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'IOP and Tolerability Study of Preserved Bimatoprost 0.1% or Tafluprost Unit Dose Preservative Free 15microgram/ml, in Patients With OHT or Glaucoma Suitable for Prostaglandin Therapy', 'orgStudyIdInfo': {'id': 'S57304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lumigan 0.01% + Saflutan 15 µg/ml', 'description': 'Bimatoprost 0.01 % Eye drops solution Topical use Once in the evening 3 months', 'interventionNames': ['Drug: Preserved Bimatoprost 0.01%', 'Drug: Tafluprost Unit Dose Preservative Free 15microgram/ml']}, {'type': 'EXPERIMENTAL', 'label': 'Saflutan 15 µg/ml + Lumigan 0.01%', 'description': 'Tafluprost Unit Dose Preservative Free 15microgram/ml Eye drops solution Topical use Once in the evening 3 months', 'interventionNames': ['Drug: Preserved Bimatoprost 0.01%', 'Drug: Tafluprost Unit Dose Preservative Free 15microgram/ml']}], 'interventions': [{'name': 'Preserved Bimatoprost 0.01%', 'type': 'DRUG', 'otherNames': ['BIMMD', 'Lumigan 0.01 %'], 'description': 'Eye drops solution Topical use Once in the evening 3 months', 'armGroupLabels': ['Lumigan 0.01% + Saflutan 15 µg/ml', 'Saflutan 15 µg/ml + Lumigan 0.01%']}, {'name': 'Tafluprost Unit Dose Preservative Free 15microgram/ml', 'type': 'DRUG', 'otherNames': ['TUDPF', 'Saflutan'], 'description': 'Eye drops solution Topical use Once in the evening 3 months', 'armGroupLabels': ['Lumigan 0.01% + Saflutan 15 µg/ml', 'Saflutan 15 µg/ml + Lumigan 0.01%']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Anton Hommer', 'role': 'CONTACT'}], 'facility': 'Hommer Ophthalmology Institute', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams Brabant', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Ingeborg Stalmans, Phd', 'role': 'CONTACT', 'email': 'ingborg.stalmans@uzleuven.be', 'phone': '003216332372'}, {'name': 'Sien Boons, Optometrist', 'role': 'CONTACT', 'email': 'sien.boons@uzleuven.be', 'phone': '003216340391'}], 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Milan', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luca Rossetti', 'role': 'CONTACT'}], 'facility': 'San Paolo Hospital', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Rome', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'francesco Oddone', 'role': 'CONTACT'}], 'facility': 'Bietti Foundation', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Geneva', 'status': 'NOT_YET_RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Gordana Megevand', 'role': 'CONTACT'}], 'facility': 'Clinical Research Centre Momorial A. de Rotschild', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'city': 'Gloucestershire', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Andrew McNaught', 'role': 'CONTACT'}], 'facility': 'Gloucestershire Hospitals NHS Foundation Trust'}, {'city': 'London', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Francesca Cordeiro', 'role': 'CONTACT'}], 'facility': 'Western Eye Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Ingeborg Stalmans, Phd', 'role': 'CONTACT', 'email': 'ingeborg.stalmans@uzleuven.be', 'phone': '003216332372'}, {'name': 'Sien Boons', 'role': 'CONTACT', 'email': 'sien.boons@uzleuven.be', 'phone': '0032163340391'}], 'overallOfficials': [{'name': 'Ingeborg Stalmans, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'collaborators': [{'name': 'Allergan', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-05-26', 'type': 'RELEASE'}, {'date': '2024-02-01', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Universitaire Ziekenhuizen KU Leuven'}}}}