Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-03-09 @ 7:04 AM
Study NCT ID:
NCT03740659
Status:
COMPLETED
Last Update Posted:
2020-07-07
First Post:
2018-11-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation Of Aqueous Humor Of Levofloxacin-Dexamethasone Eye Drops And Of Its Components In Patients Undergoing Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064704', 'term': 'Levofloxacin'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D015242', 'term': 'Ofloxacin'}, {'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alessandro.colombo@ntcpharma.com', 'phone': '+390243850490', 'title': 'Alessandro Colombo', 'organization': 'NTC srl'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From baseline to the study completion, approximately 2 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Levofloxacin + Dexamethasone', 'description': 'Levofloxacin 0.5% + DSP 0.132% (w/v) eye drops (TEST product). One ml contains levofloxacin hemihydrate 5.12 mg, corresponding to 5 mg of levofloxacin, and DSP 1.32 mg, corresponding to 1 mg of dexamethasone.\n\nAdministration route: ocular instillation\n\nDose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin and 39.6 μg DSP).', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Levofloxacin', 'description': 'Levofloxacin 0.5% eye drops (Oftaquix®). One ml contains 5,12 mg of levofloxacin hemihydrate equal to 5 mg of levofloxacin.\n\nAdministration route: ocular instillation\n\nDose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin).', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Dexamethasone', 'description': 'Dexamethasone sodium phosphate 0.15% eye drops (Tamesad®). One ml contains 1.5 mg of DSP corresponding to 1.14 mg/ml of dexamethasone.\n\nAdministration route: ocular instillation\n\nDose and regimen: two 26 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose containing 39 μg DSP).', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 1, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Mild Mydriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Aqueous Humour Concentration of Levofloxacin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Levofloxacin + Dexamethasone', 'description': 'Levofloxacin 0.5% + DSP 0.132% (w/v) eye drops (TEST product). One ml contains levofloxacin hemihydrate 5.12 mg, corresponding to 5 mg of levofloxacin, and DSP 1.32 mg, corresponding to 1 mg of dexamethasone.\n\nAdministration route: ocular instillation\n\nDose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin and 39.6 μg DSP).'}, {'id': 'OG001', 'title': 'Levofloxacin', 'description': 'Levofloxacin 0.5% eye drops (Oftaquix®). One ml contains 5,12 mg of levofloxacin hemihydrate equal to 5 mg of levofloxacin.\n\nAdministration route: ocular instillation\n\nDose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin).'}, {'id': 'OG002', 'title': 'Dexamethasone', 'description': 'Dexamethasone sodium phosphate 0.15% eye drops (Tamesad®). One ml contains 1.5 mg of DSP corresponding to 1.14 mg/ml of dexamethasone.\n\nAdministration route: ocular instillation\n\nDose and regimen: two 26 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose containing 39 μg DSP).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.970', 'groupId': 'OG000', 'lowerLimit': '1.648', 'upperLimit': '2.292'}, {'value': '2.151', 'groupId': 'OG001', 'lowerLimit': '1.708', 'upperLimit': '2.594'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90±15 min after the first administration of the study treatments', 'description': 'Defined as the concentration of levofloxacin into the aqueous humour in all the three arms: Levofloxacin + Dexamethasone, Dexamethasone and Levofloxacin.The concentration of levofloxacin has been measured by LC tandem mass spectrometry.', 'unitOfMeasure': 'nmol/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in all Arms/Groups were assessed for this Outcome Measure regardless of treatment type'}, {'type': 'PRIMARY', 'title': 'Aqueous Humour Concentration of Dexamethasone 21-phosphate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Levofloxacin + Dexamethasone', 'description': 'Levofloxacin 0.5% + DSP 0.132% (w/v) eye drops (TEST product). One ml contains levofloxacin hemihydrate 5.12 mg, corresponding to 5 mg of levofloxacin, and DSP 1.32 mg, corresponding to 1 mg of dexamethasone.\n\nAdministration route: ocular instillation\n\nDose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin and 39.6 μg DSP).'}, {'id': 'OG001', 'title': 'Levofloxacin', 'description': 'Levofloxacin 0.5% eye drops (Oftaquix®). One ml contains 5,12 mg of levofloxacin hemihydrate equal to 5 mg of levofloxacin.\n\nAdministration route: ocular instillation\n\nDose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin).'}, {'id': 'OG002', 'title': 'Dexamethasone', 'description': 'Dexamethasone sodium phosphate 0.15% eye drops (Tamesad®). One ml contains 1.5 mg of DSP corresponding to 1.14 mg/ml of dexamethasone.\n\nAdministration route: ocular instillation\n\nDose and regimen: two 26 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose containing 39 μg DSP).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90±15 min after the first administration of the study treatments', 'description': 'Defined as the concentration of dexamethasone 21-phosphate into the aqueous humour in all the three arms: Levofloxacin + Dexamethasone, Dexamethasone and Levofloxacin. The concentration of dexamethasone 21-phosphate has been measured by LC tandem mass spectrometry.', 'unitOfMeasure': 'nmol/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in all Arms/Groups were assessed for this Outcome Measure regardless of treatment type'}, {'type': 'PRIMARY', 'title': 'Aqueous Humour Concentration of Dexamethasone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Levofloxacin + Dexamethasone', 'description': 'Levofloxacin 0.5% + DSP 0.132% (w/v) eye drops (TEST product). One ml contains levofloxacin hemihydrate 5.12 mg, corresponding to 5 mg of levofloxacin, and DSP 1.32 mg, corresponding to 1 mg of dexamethasone.\n\nAdministration route: ocular instillation\n\nDose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin and 39.6 μg DSP).'}, {'id': 'OG001', 'title': 'Levofloxacin', 'description': 'Levofloxacin 0.5% eye drops (Oftaquix®). One ml contains 5,12 mg of levofloxacin hemihydrate equal to 5 mg of levofloxacin.\n\nAdministration route: ocular instillation\n\nDose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin).'}, {'id': 'OG002', 'title': 'Dexamethasone', 'description': 'Dexamethasone sodium phosphate 0.15% eye drops (Tamesad®). One ml contains 1.5 mg of DSP corresponding to 1.14 mg/ml of dexamethasone.\n\nAdministration route: ocular instillation\n\nDose and regimen: two 26 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose containing 39 μg DSP).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.030', 'groupId': 'OG000', 'lowerLimit': '0.025', 'upperLimit': '0.035'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0.042', 'groupId': 'OG002', 'lowerLimit': '0.035', 'upperLimit': '0.048'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90±15 min after the first administration of the study treatments', 'description': 'Defined as the concentration of dexamethasone into the aqueous humour in all the three arms: Levofloxacin + Dexamethasone, Dexamethasone and Levofloxacin.The concentration of dexamethasone has been measured by LC tandem mass spectrometry.', 'unitOfMeasure': 'nmol/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in all Arms/Groups were assessed for this Outcome Measure regardless of treatment type'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Levofloxacin + Dexamethasone', 'description': 'Levofloxacin 0.5% + DSP 0.132% (w/v) eye drops (TEST product). One ml contains levofloxacin hemihydrate 5.12 mg, corresponding to 5 mg of levofloxacin, and DSP 1.32 mg, corresponding to 1 mg of dexamethasone.\n\nAdministration route: ocular instillation\n\nDose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin and 39.6 μg DSP).'}, {'id': 'FG001', 'title': 'Levofloxacin', 'description': 'Levofloxacin 0.5% eye drops (Oftaquix®). One ml contains 5,12 mg of levofloxacin hemihydrate equal to 5 mg of levofloxacin.\n\nAdministration route: ocular instillation\n\nDose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin).'}, {'id': 'FG002', 'title': 'Dexamethasone', 'description': 'Dexamethasone sodium phosphate 0.15% eye drops (Tamesad®). One ml contains 1.5 mg of DSP corresponding to 1.14 mg/ml of dexamethasone.\n\nAdministration route: ocular instillation\n\nDose and regimen: two 26 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose containing 39 μg DSP).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Study Period:\n\n* Date of first enrolment: 4 September 2018\n* Date study finalized (last patient last visit): 6 December 2018\n\nStudy centres:\n\n* U.O. Oculistica Universitaria, Azienda Ospedaliera Universitaria Pisana, Presidio Ospedaliero di Cisanello, Pisa;\n* Clinica Oculistica, Presidio Ospedale San Paolo, Milan.', 'preAssignmentDetails': 'Planned sample size n.120; randomized patients n.125; screened patients n.133 (1 patient screened for both eyes).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '125', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Levofloxacin + Dexamethasone', 'description': 'Levofloxacin 0.5% + DSP 0.132% (w/v) eye drops (TEST product). One ml contains levofloxacin hemihydrate 5.12 mg, corresponding to 5 mg of levofloxacin, and DSP 1.32 mg, corresponding to 1 mg of dexamethasone.\n\nAdministration route: ocular instillation\n\nDose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin and 39.6 μg DSP).'}, {'id': 'BG001', 'title': 'Levofloxacin', 'description': 'Levofloxacin 0.5% eye drops (Oftaquix®). One ml contains 5,12 mg of levofloxacin hemihydrate equal to 5 mg of levofloxacin.\n\nAdministration route: ocular instillation\n\nDose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin).'}, {'id': 'BG002', 'title': 'Dexamethasone', 'description': 'Dexamethasone sodium phosphate 0.15% eye drops (Tamesad®). One ml contains 1.5 mg of DSP corresponding to 1.14 mg/ml of dexamethasone.\n\nAdministration route: ocular instillation\n\nDose and regimen: two 26 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose containing 39 μg DSP).'}, {'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': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.45', 'spread': '7.60', 'groupId': 'BG000'}, {'value': '75.38', 'spread': '8.38', 'groupId': 'BG001'}, {'value': '74.59', 'spread': '8.00', 'groupId': 'BG002'}, {'value': '74.14', 'spread': '8.03', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '122', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '125', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Main eligibility criteria included patients of both genders, aged ≥40 years and scheduled for phacoemulsification.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-21', 'size': 17994767, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-10-03T11:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Single'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized, assessor-blinded, parallel-group study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-19', 'studyFirstSubmitDate': '2018-11-06', 'resultsFirstSubmitDate': '2020-05-13', 'studyFirstSubmitQcDate': '2018-11-13', 'lastUpdatePostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-19', 'studyFirstPostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aqueous Humour Concentration of Levofloxacin', 'timeFrame': '90±15 min after the first administration of the study treatments', 'description': 'Defined as the concentration of levofloxacin into the aqueous humour in all the three arms: Levofloxacin + Dexamethasone, Dexamethasone and Levofloxacin.The concentration of levofloxacin has been measured by LC tandem mass spectrometry.'}, {'measure': 'Aqueous Humour Concentration of Dexamethasone 21-phosphate', 'timeFrame': '90±15 min after the first administration of the study treatments', 'description': 'Defined as the concentration of dexamethasone 21-phosphate into the aqueous humour in all the three arms: Levofloxacin + Dexamethasone, Dexamethasone and Levofloxacin. The concentration of dexamethasone 21-phosphate has been measured by LC tandem mass spectrometry.'}, {'measure': 'Aqueous Humour Concentration of Dexamethasone', 'timeFrame': '90±15 min after the first administration of the study treatments', 'description': 'Defined as the concentration of dexamethasone into the aqueous humour in all the three arms: Levofloxacin + Dexamethasone, Dexamethasone and Levofloxacin.The concentration of dexamethasone has been measured by LC tandem mass spectrometry.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cataract']}, 'referencesModule': {'references': [{'pmid': '32285142', 'type': 'DERIVED', 'citation': 'Figus M, Posarelli C, Romano D, Nardi M, Rossetti L. Aqueous humour concentrations after topical apPlication of combinEd levofloxacin-dexamethasone eye dRops and of its single components: a randoMised, assEssor-blinded, parallel-group study in patients undergoing cataract surgery: the iPERME study. Eur J Clin Pharmacol. 2020 Jul;76(7):929-937. doi: 10.1007/s00228-020-02863-7. Epub 2020 Apr 13.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the penetration of levofloxacin and dexamethasone 21-phosphate into the aqueous humour after ocular administration in combination or as single active ingredients.', 'detailedDescription': 'In most cases, postoperative care after cataract surgery consists of antiinflammatory and antibacterial drug therapy. The use of an ophthalmic solution containing the combination of a steroid and an antibiotic is routinely used in clinical practice; however, treatment duration could favour the emergence of antibiotic resistance. The study treatment associating a broad-spectrum antibiotic with a highly effective corticosteroid that can be used for a short period of time (one week) is therefore of considerable interest.\n\nThe aim of this study is to measure the concentrations of levofloxacin and dexamethasone in the aqueous humour after topical application of the combined ophthalmic solution and its single components.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Written informed consent\n2. Male or female patients, aged ≥40 years\n3. Patient undergoing phacoemulsification\n4. Corneal thickness between 450 μm and 600 μm as measured by means of pachymetry\n5. Corneal integrity confirmed by means of fluorescein test\n6. Adequate pupil dilation assessed at screening\n7. Female patients of childbearing potential must have a negative pregnancy test\n8. Ability to fully understand all study procedures\n\nExclusion Criteria:\n\n1. Corneal epithelium integrity not confirmed by fluorescein test\n2. History of corneal disease or dystrophy\n3. History of ocular trauma with corneal damage\n4. History of acute ocular inflammation (including uveitis) in the 6 months prior to screening\n5. Previous ocular surgery (including laser treatment)\n6. Glaucoma\n7. Treatment with an ophthalmic investigational drug in the 3 months prior to screening\n8. Treatment with any topical ocular drug within 12 hours before start of cataract surgery other than study drugs and instillation of topical anaesthetic within 10 minutes before start of surgery\n9. Treatment with any topical steroid or antibiotic drug in the 7 days prior to cataract surgery\n10. Treatment with any systemic steroid or antibiotic drug in the 7 days prior to cataract surgery\n11. Known hypersensitivity to levofloxacin, other fluoroquinolones or dexamethasone\n12. Pregnant or lactating women\n13. Patients who have received any investigational drug during the preceding 30 days or 5 times the plasma half-life, or who have previously participated in this trial'}, 'identificationModule': {'nctId': 'NCT03740659', 'acronym': 'iPERME', 'briefTitle': 'Evaluation Of Aqueous Humor Of Levofloxacin-Dexamethasone Eye Drops And Of Its Components In Patients Undergoing Cataract Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'NTC srl'}, 'officialTitle': 'Aqueous Humour Concentrations After Topical apPlication of combinEd Levofloxacin-dexamethasone Eye dRops and of Its Single Components: a randoMized, assEssor-blinded, Parallel-group Study in Patients Undergoing Cataract Surgery - iPERME', 'orgStudyIdInfo': {'id': 'LevoDesa_05-2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Levofloxacin + Dexamethasone', 'description': 'Levofloxacin 5 mg/ml + Dexamethasone 1 mg/ml (30 μl administered twice before Limbal paracentesis).\n\nLimbal paracentesis will be performed prior to cataract surgery.', 'interventionNames': ['Drug: Levofloxacin + Dexamethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Levofloxacin', 'description': 'Levofloxacin 5 mg/ml (30 μl administered twice before Limbal paracentesis).\n\nLimbal paracentesis will be performed prior to cataract surgery.', 'interventionNames': ['Drug: Levofloxacin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexamethasone', 'description': 'Dexamethasone 1.14 mg/ml (26 μl administered twice before Limbal paracentesis).\n\nLimbal paracentesis will be performed prior to cataract surgery.', 'interventionNames': ['Drug: Dexamethasone']}], 'interventions': [{'name': 'Levofloxacin + Dexamethasone', 'type': 'DRUG', 'description': 'Levofloxacin + Dexamethasone ophthalmic solution + dexamethasone 21-phosphate administered twice: 90(±15) min. and 60(±15) min. before limbal paracentesis.', 'armGroupLabels': ['Levofloxacin + Dexamethasone']}, {'name': 'Levofloxacin', 'type': 'DRUG', 'otherNames': ['Oftaquix®'], 'description': 'Levofloxacin ophthalmic solution (Oftaquix®) administered twice: 90 (±15) min. and 60 (±15) min. before limbal paracentesis).', 'armGroupLabels': ['Levofloxacin']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['Tamesad®'], 'description': 'Dexamethasone ophthalmic solution (Tamesad®) administered twice: 90 (±15) min. and 60 (±15) min. before Limbal paracentesis.', 'armGroupLabels': ['Dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20142', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'ASST Santi Paolo e Carlo di Milano - P.O. San Paolo di Milano', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '56124', 'city': 'Pisa', 'state': 'PI', 'country': 'Italy', 'facility': 'A.O.U. Pisana - P.O. di Cisanello', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}], 'overallOfficials': [{'name': 'Marco Nardi, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'A.O.U. Pisana - P.O. di Cisanello'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NTC srl', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}