Ignite Creation Date:
2025-12-24 @ 7:30 PM
Ignite Modification Date:
2025-12-30 @ 9:54 PM
Study NCT ID:
NCT01162603
Status:
COMPLETED
Last Update Posted:
2013-05-07
First Post:
2010-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Latanoprost Versus Tafluprost: 24-hour Intraocular Pressure (IOP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C485333', 'term': 'tafluprost'}, {'id': 'D009883', 'term': 'Ophthalmic Solutions'}, {'id': 'D000077338', 'term': 'Latanoprost'}], 'ancestors': [{'id': 'D019999', 'term': 'Pharmaceutical Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D011461', 'term': 'Prostaglandins F, Synthetic'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-05', 'studyFirstSubmitDate': '2010-07-13', 'studyFirstSubmitQcDate': '2010-07-13', 'lastUpdatePostDateStruct': {'date': '2013-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular Pressure', 'timeFrame': '24-hour', 'description': 'Primary endpoint of this crossover trial is to compare the ability of Latanoprost 0.005% preservative-added ophthalmic solution versus Tafluprost 0.0015% preservative-free ophthalmic solution, both given once a day at the evening, in reducing 24-hour intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) and/or ocular hypertension (OHT) at first diagnosis. First efficacy variable will be the difference between mean nocturnal IOP values after three months of treatment: nocturnal IOP is defined as the mean value between 2AM and 6AM measurements.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Primary Open Angle Glaucoma', 'Ocular Hypertension']}, 'referencesModule': {'references': [{'pmid': '20545217', 'type': 'BACKGROUND', 'citation': 'Kuwayama Y, Komemushi S; Tafluprost Multi-center Study Group. [Intraocular pressure lowering effect of 0.0015% tafluprost as compared to placebo in patients with normal tension glaucoma: randomized, double-blind, multicenter, phase III study]. Nippon Ganka Gakkai Zasshi. 2010 May;114(5):436-43. Japanese.'}, {'pmid': '20420586', 'type': 'BACKGROUND', 'citation': 'Uusitalo H, Pillunat LE, Ropo A; Phase III Study Investigators. Efficacy and safety of tafluprost 0.0015% versus latanoprost 0.005% eye drops in open-angle glaucoma and ocular hypertension: 24-month results of a randomized, double-masked phase III study. Acta Ophthalmol. 2010 Feb;88(1):12-9. doi: 10.1111/j.1755-3768.2010.01862.x.'}, {'pmid': '20390038', 'type': 'BACKGROUND', 'citation': 'Aihara M. Clinical appraisal of tafluprost in the reduction of elevated intraocular pressure (IOP) in open-angle glaucoma and ocular hypertension. Clin Ophthalmol. 2010 Mar 24;4:163-70. doi: 10.2147/opth.s6368.'}, {'pmid': '20553122', 'type': 'RESULT', 'citation': 'Hommer A, Mohammed Ramez O, Burchert M, Kimmich F. IOP-lowering efficacy and tolerability of preservative-free tafluprost 0.0015% among patients with ocular hypertension or glaucoma. Curr Med Res Opin. 2010 Aug;26(8):1905-13. doi: 10.1185/03007995.2010.492030.'}, {'pmid': '23681371', 'type': 'DERIVED', 'citation': 'Konstas AG, Quaranta L, Katsanos A, Riva I, Tsai JC, Giannopoulos T, Voudouragkaki IC, Paschalinou E, Floriani I, Haidich AB. Twenty-four hour efficacy with preservative free tafluprost compared with latanoprost in patients with primary open angle glaucoma or ocular hypertension. Br J Ophthalmol. 2013 Dec;97(12):1510-5. doi: 10.1136/bjophthalmol-2012-303026. Epub 2013 May 16.'}]}, 'descriptionModule': {'briefSummary': '* Main objective is to compare the ability of Latanoprost 0.005% preservative-added ophthalmic solution versus Tafluprost 0.0015% preservative-free ophthalmic solution, both given once a day at the evening, in reducing 24-hour intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) and/or ocular hypertension (OHT) at first diagnosis. First efficacy variable will be the difference between mean nocturnal IOP values after three months of treatment: nocturnal IOP is defined as the mean value between 2AM and 6AM measurements.\n* Secondary objectives will be the comparison between Latanoprost 0.005% and Tafluprost 0.0015% ophthalmic solution about:\n\n * Mean 24-hour IOP values after three months of treatment\n * IOP values at these time-points: 10AM (± 1 hour), 2PM (± 1 hour), 6PM (± 1 hour), 10PM (± 1 hour), 2AM (± 1 hour) and 6AM (± 1 hour) after three months of treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients \\> 45 years\n* Damage of the optic nerve and alterations of the visual field in case of POAG, no defects at the optic nerve and at the visual field in case of OHT\n* Untreated IOP \\> 24 mm Hg but \\< 32 mm Hg in at least one eye at baseline (10AM) and central corneal thickness between 500 and 600 μm\n* Negative pregnancy test (fertile women). Fertile women attending the study must express clear will to avoid pregnancy during all the study period and in the next three months\n* Informed consent before starting the study\n\nExclusion Criteria:\n\n* Secondary glaucoma (Sturge-Weber syndrome, Neurofibromatosis I, neovascular glaucoma, steroid glaucoma, etc)\n* Anterior segment anomalies (cataract, irido-corneal disgenesy, congenital ectropion uvae, etc)\n* Past ocular surgery, except cataract surgery in the previous 6 months\n* Corneal abnormalities that can influence IOP measurements (corneal oedema)\n* Positive pregnancy test or breast-feeding woman. No will to avoid pregnancy during all the study period and in the next three months'}, 'identificationModule': {'nctId': 'NCT01162603', 'acronym': 'SAF-24H-IOP', 'briefTitle': 'Latanoprost Versus Tafluprost: 24-hour Intraocular Pressure (IOP)', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia'}, 'officialTitle': 'Comparative Evaluation of Intraocular Pressure During the 24 Hour in Patients Affected by Primary Open-angle Glaucoma and Ocular Hypertension: Latanoprost 0.005% Versus Tafluprost 0.0015% Ophthalmic Solutions', 'orgStudyIdInfo': {'id': 'AOBS-SAF-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAFLUPROST 0.0015% EYEDROPS', 'description': 'Tafluprost 0.0015% preservative-free ophthalmic solution will be given once a day at the evening,in patients with primary open angle glaucoma (POAG) and/or ocular hypertension (OHT) at first diagnosis. IOP values after three months of treatment will be evaluated throughout the 24-hour by the means of Goldmann and Perkins applanation tonometry.', 'interventionNames': ['Device: Goldmann and Perkins applanation tonometry', 'Drug: TAFLUPROST 0.0015% EYEDROPS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LATANOPROST 0.005% EYEDROPS', 'description': 'Latanoprost 0.005% preservative-added ophthalmic solution will be given once a day at the evening,in patients with primary open angle glaucoma (POAG) and/or ocular hypertension (OHT) at first diagnosis. IOP values after three months of treatment will be evaluated throughout the 24-hour by the means Goldmann and Perkins applanation tonometry.', 'interventionNames': ['Device: Goldmann and Perkins applanation tonometry', 'Drug: LATANOPROST 0.005% EYEDROPS']}], 'interventions': [{'name': 'Goldmann and Perkins applanation tonometry', 'type': 'DEVICE', 'otherNames': ['Saflutan, Merck Sharp & Dhome', 'Latanoprost 0.005% generic drug'], 'description': 'IOP values will be assessed by the means of Goldmann or Perkins applanation tonometry at the following time-points: 10AM (± 1 hour), 2PM (± 1 hour), 6PM (± 1 hour), 10PM (± 1 hour), 2AM (± 1 hour) and 6AM (± 1 hour) after three months of treatment', 'armGroupLabels': ['LATANOPROST 0.005% EYEDROPS', 'TAFLUPROST 0.0015% EYEDROPS']}, {'name': 'TAFLUPROST 0.0015% EYEDROPS', 'type': 'DRUG', 'otherNames': ['Saflutan, MSD'], 'description': 'Tafluprost 0.0015% preservative-free ophthalmic solution', 'armGroupLabels': ['TAFLUPROST 0.0015% EYEDROPS']}, {'name': 'LATANOPROST 0.005% EYEDROPS', 'type': 'DRUG', 'otherNames': ['Latanoprost 0.005% eyedrops generic drug'], 'description': 'Latanoprost 0.005% preservative-added ophthalmic solution', 'armGroupLabels': ['LATANOPROST 0.005% EYEDROPS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54636', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Glaucoma Unit, 1st University Department of Ophthalmology, Aristotle University, AHEPA Hospital', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '25123', 'city': 'Brescia', 'country': 'Italy', 'facility': 'USVD "Centro per lo studio del glaucoma" Spedali civili di Brescia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}], 'overallOfficials': [{'name': 'Luciano Quaranta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Università degli Studi di Brescia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aristotle University Of Thessaloniki', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor in Ophthalmology', 'investigatorFullName': 'Luciano Quaranta, MD', 'investigatorAffiliation': 'Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia'}}}}