Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2026-03-02 @ 8:38 AM
Study NCT ID:
NCT02017327
Status:
COMPLETED
Last Update Posted:
2020-04-02
First Post:
2013-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Assessment of Monoprost® in Comparison With Lumigan® 0.01 % and Lumigan® 0.03% Unit Dose
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D000069580', 'term': 'Bimatoprost'}], 'ancestors': [{'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003008', 'term': 'Cloprostenol'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'J.auger@laboratoires-thea.fr', 'phone': '+473985089', 'title': 'Director of medical operation', 'organization': 'Laboratoires Thea'}, 'certainAgreement': {'otherDetails': 'All the results of the Trial are the sole and exclusive property of THEA, and cannot be used in whatever form without prior written agreement of THEA.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Monoprost', 'description': '1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.\n\nMonoprost: Monoprost®: Latanoprost 0.005% ophthalmic preparation is a sterile unpreserved oil-based solution for topical ophthalmic use. It is supplied in 0.30 ml single use polyethylene containers. The batch numbers and reanalysis dates will be stated in the certificate of analysis.', 'otherNumAtRisk': 119, 'otherNumAffected': 0, 'seriousNumAtRisk': 119, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Lumigan 0.01%', 'description': '1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.\n\nLumigan 0.01%: Lumigan® 0.01%: Bimatoprost eye drop solution is supplied in 3 ml multidose container.', 'otherNumAtRisk': 124, 'otherNumAffected': 0, 'seriousNumAtRisk': 124, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Lumigan 0.03% Unit Dose', 'description': '1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.\n\nLumigan 0.03% Unit Dose: Lumigan® 0.03% Unit Dose: Bimatoprost eye drop solution is supplied in 0.4 ml single use low density polyethylene (LDPE) containers.', 'otherNumAtRisk': 130, 'otherNumAffected': 0, 'seriousNumAtRisk': 130, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'intervetebral disk protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'breast neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'metastatic colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety With Respect to the Assessment of Conjunctival Hyperaemia in the Worse Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Monoprost', 'description': '1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.\n\nMonoprost: Monoprost®: Latanoprost 0.005% ophthalmic preparation is a sterile unpreserved oil-based solution for topical ophthalmic use. It is supplied in 0.30 ml single use polyethylene containers. The batch numbers and reanalysis dates will be stated in the certificate of analysis.'}, {'id': 'OG001', 'title': 'Lumigan 0.01%', 'description': '1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.\n\nLumigan 0.01%: Lumigan® 0.01%: Bimatoprost eye drop solution is supplied in 3 ml multidose container.'}, {'id': 'OG002', 'title': 'Lumigan 0.03% Unit Dose', 'description': '1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.\n\nLumigan 0.03% Unit Dose: Lumigan® 0.03% Unit Dose: Bimatoprost eye drop solution is supplied in 0.4 ml single use low density polyethylene (LDPE) containers.'}], 'classes': [{'categories': [{'title': 'change at D84 -3', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}, {'title': 'change at D84 - 2', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}, {'title': 'change at D84 -1', 'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}, {'title': 'change at D84 0', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}, {'title': 'change at D84 +1', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}, {'title': 'change at D84 +2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'missing data', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0045', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 84', 'description': 'The primary endpoint is the change from baseline of conjunctival hyperaemia assessed on MacMonnies\' 6 point ordinal scale, in the worse eye at the D84 visit. The primary statistical hypothesis tested is that Monoprost® is superior to Lumigan® 0.03% Unit Dose with regard to this primary endpoint, i.e. that in the worse eye the decrease from baseline in the MacMonnies 6 point ordinal scale is greater in the Monoprost® treated group than in the Lumigan® 0.03% Unit Dose group at the Day 84 visit.\n\nThe conjunctival hyperaemia will be scored using the "McMonnies" photographic scale (0 to 5). The minimum score is 0 corresponding to a low hyperaemia and the maximum score is 5 corresponding to a higher hyperaemia.\n\nThe Rows represent the number of participants with a change from Baseline to D84 corresponding to\n\n* "decrease of 3 points"\n* "decrease of 2 points"\n* "no change",\n* "increase of 2 points"\n* "increase of 1 point" on Mc Monnies scale', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'the primary analysis was performed in the mSAF.(All randomised patients of the Safety set with at least one eligible eye and with any safety information on treatment.)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Monoprost', 'description': '1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.\n\nMonoprost: Monoprost®: Latanoprost 0.005% ophthalmic preparation is a sterile unpreserved oil-based solution for topical ophthalmic use. It is supplied in 0.30 ml single use polyethylene containers. The batch numbers and reanalysis dates will be stated in the certificate of analysis.'}, {'id': 'FG001', 'title': 'Lumigan 0.01% (Bimatoprost Eye Drop Solution)', 'description': '1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.\n\n3-mL multidose containers'}, {'id': 'FG002', 'title': 'Lumigan 0.03% UD (Bimatoprost Eye Drop Solution)', 'description': 'one drop in each eye once daily at 9.00 pm (± 1 hour) in the inferior conjunctival cul-de-sac from D0 to D84.\n\n0.4-mL single-use low density polyethylene (LDPE) containers.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '125'}, {'groupId': 'FG002', 'numSubjects': '132'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '113'}, {'groupId': 'FG002', 'numSubjects': '117'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '15'}]}]}], 'recruitmentDetails': 'patients were enrolled at medical clinics from Dec 2013 to July 2016', 'preAssignmentDetails': 'the number of patients enrolled in 379 but as the primary Endpoint is Safety, the Baseline population is based on the safety Set and it corresponds to 373 patients'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}, {'value': '373', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Monoprost', 'description': '1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.\n\nMonoprost: Monoprost®: Latanoprost 0.005% ophthalmic preparation is a sterile unpreserved oil-based solution for topical ophthalmic use. It is supplied in 0.30 ml single use polyethylene containers. The batch numbers and reanalysis dates will be stated in the certificate of analysis.'}, {'id': 'BG001', 'title': 'Lumigan 0.01%', 'description': '1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.\n\nLumigan 0.01%: Lumigan® 0.01%: Bimatoprost eye drop solution is supplied in 3 ml multidose container.'}, {'id': 'BG002', 'title': 'Lumigan 0.03% Unit Dose', 'description': '1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.\n\nLumigan 0.03% Unit Dose: Lumigan® 0.03% Unit Dose: Bimatoprost eye drop solution is supplied in 0.4 ml single use low density polyethylene (LDPE) containers.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '138', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '235', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.5', 'spread': '9.9', 'groupId': 'BG000'}, {'value': '67.4', 'spread': '10.3', 'groupId': 'BG001'}, {'value': '68.3', 'spread': '10', 'groupId': 'BG002'}, {'value': '67.7', 'spread': '10.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '218', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '155', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '153', 'groupId': 'BG003'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}]}]}, {'title': 'Greece', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 379}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-20', 'studyFirstSubmitDate': '2013-12-02', 'resultsFirstSubmitDate': '2018-03-30', 'studyFirstSubmitQcDate': '2013-12-16', 'lastUpdatePostDateStruct': {'date': '2020-04-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-20', 'studyFirstPostDateStruct': {'date': '2013-12-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety With Respect to the Assessment of Conjunctival Hyperaemia in the Worse Eye', 'timeFrame': 'Day 84', 'description': 'The primary endpoint is the change from baseline of conjunctival hyperaemia assessed on MacMonnies\' 6 point ordinal scale, in the worse eye at the D84 visit. The primary statistical hypothesis tested is that Monoprost® is superior to Lumigan® 0.03% Unit Dose with regard to this primary endpoint, i.e. that in the worse eye the decrease from baseline in the MacMonnies 6 point ordinal scale is greater in the Monoprost® treated group than in the Lumigan® 0.03% Unit Dose group at the Day 84 visit.\n\nThe conjunctival hyperaemia will be scored using the "McMonnies" photographic scale (0 to 5). The minimum score is 0 corresponding to a low hyperaemia and the maximum score is 5 corresponding to a higher hyperaemia.\n\nThe Rows represent the number of participants with a change from Baseline to D84 corresponding to\n\n* "decrease of 3 points"\n* "decrease of 2 points"\n* "no change",\n* "increase of 2 points"\n* "increase of 1 point" on Mc Monnies scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Primary Open Angle Glaucoma', 'Ocular Hypertension']}, 'descriptionModule': {'briefSummary': 'Primary objective:\n\nThe primary objective is to demonstrate the superiority of Monoprost® versus Lumigan® 0.01% and Lumigan® 0.03% Unit Dose in term of safety with respect to the assessment of conjunctival hyperaemia in the worse eye at Day 84.\n\nThe conjunctival hyperaemia will be scored using the MacMonnies photographic scale (0 to 5).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female aged ≥18 years old.\n* Written informed consent.\n* Association of the 3 following criteria:\n\n 1. Both eyes have primary open angle glaucoma or ocular hypertension already treated and controlled by mono-therapy of Lumigan® 0.01% since at least 3 months (according to European Glaucoma Society guidelines).\n 2. Intra Ocular Pressure ≤ 18 mm Hg in both eyes.\n 3. With local intolerance signs in at least one eye defined by the association of:\n\n3.1 Hyperaemia = Grade (2) or (3) or (4) following the photographic MacMonnies scale.\n\nAnd 3.2.1 Presence of at least 2 symptoms with a level of severity ≥ 1 (= mild or moderate or severe) among the following 5 symptoms: irritation/burning, itching, tearing, eye dryness sensation, foreign body sensation.\n\nAnd/Or 3.2.2 Presence of at least 2 signs with a level of severity ≥ 1 (= mild or moderate or severe) among the following 3 signs: superficial punctate keratitis, blepharitis, eyelid skin darkness.\n\nExclusion Criteria:\n\n* \\- Presence of at least one severe objective sign among the following:\n\n * Global ocular staining with Oxford (0-15) grading scheme \\>12.\n * Blepharitis (Grade 4: Very severe, i.e. eczematiform lesion).\n* Any ocular hypertension other than primary ocular hypertension or primary chronic open angle glaucoma (such as congenital, angle closure glaucoma, secondary glaucoma).\n* Visual field not performed or not available within the 6 months before inclusion visit.\n* Fundus not performed or not available within the 6 months before inclusion visit.\n* Advanced stage of glaucoma:\n\n * Absolute defect in the ten degrees central point of the visual field.\n * Severe visual field loss according to the investigator's best judgement.\n * Risk of visual field worsening as a consequence of participation in the trial according to the investigator's best judgement.\n* Best far corrected visual acuity ≤ 1/10.\n* History of trauma, infection, inflammation within the 3 months before inclusion visit.\n* Ongoing or known history of ocular allergy and/or uveitis and/or viral infection.\n* Severe dry eye (defined by severe epithelial erosions of the cornea and/or use of dry eye medication with a frequency exceeding 8 instillations / day).\n* Corneal ulceration.\n* Palpebral abnormalities not related to medical treatment study and incompatible with a good evaluation.\n* Any abnormality preventing accurate assessment e.g. reliable tonometry measurement, visual field examination.\n\nSystemic/non ophthalmic/ exclusion criteria\n\n* Non-controlled diabetic patient.\n* Known or suspected hypersensitivity to one of the components of the study product.\n* Any medical or surgical history, disorder or disease such as acute or chronic severe organic disease: hepatic, endocrine, neoplastic, haematological; immunosuppressive, infectious diseases, severe psychiatric illness, relevant cardiovascular abnormalities, etc… and/or any complicating factor or structural abnormality, judged by the investigator to be incompatible with the study.\n\nSpecific exclusion criteria for women\n\n* Pregnancy, lactation.\n* Childbearing potential woman who is not using a reliable method of contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant, vaginal ring, patch) and is not surgically sterilised."}, 'identificationModule': {'nctId': 'NCT02017327', 'briefTitle': 'Safety and Efficacy Assessment of Monoprost® in Comparison With Lumigan® 0.01 % and Lumigan® 0.03% Unit Dose', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoires Thea'}, 'officialTitle': 'Safety and Efficacy Assessment of Monoprost® in Comparison With Lumigan® 0.01% and Lumigan® 0.03% Unit Dose, in Patients With Primary Open Angle Glaucoma or Ocular Hypertension, Stabilized by Lumigan® 0.01% With Ocular Surface Intolerance', 'orgStudyIdInfo': {'id': 'LT2345-PIV-02/13'}, 'secondaryIdInfos': [{'id': '2013-001250-10', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Monoprost', 'description': '1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.', 'interventionNames': ['Drug: Monoprost']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lumigan 0.01%', 'description': '1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.', 'interventionNames': ['Drug: Lumigan 0.01%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lumigan 0.03% Unit Dose', 'description': '1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.', 'interventionNames': ['Drug: Lumigan 0.03% Unit Dose']}], 'interventions': [{'name': 'Monoprost', 'type': 'DRUG', 'otherNames': ['Latanoprost 0.005%'], 'description': 'Monoprost®: Latanoprost 0.005% ophthalmic preparation is a sterile unpreserved oil-based solution for topical ophthalmic use. It is supplied in 0.30 ml single use polyethylene containers. The batch numbers and reanalysis dates will be stated in the certificate of analysis.', 'armGroupLabels': ['Monoprost']}, {'name': 'Lumigan 0.01%', 'type': 'DRUG', 'otherNames': ['Bimatoprost 0.1mg/ml'], 'description': 'Lumigan® 0.01%: Bimatoprost eye drop solution is supplied in 3 ml multidose container.', 'armGroupLabels': ['Lumigan 0.01%']}, {'name': 'Lumigan 0.03% Unit Dose', 'type': 'DRUG', 'otherNames': ['Bimatoprost 0.3mg/ML'], 'description': 'Lumigan® 0.03% Unit Dose: Bimatoprost eye drop solution is supplied in 0.4 ml single use low density polyethylene (LDPE) containers.', 'armGroupLabels': ['Lumigan 0.03% Unit Dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Laboratoires Théa', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Christophe Baudouin, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital des XV-XX'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoires Thea', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}