Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-29 @ 2:30 PM
Study NCT ID:
NCT01657266
Status:
COMPLETED
Last Update Posted:
2018-10-30
First Post:
2012-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of PRO-155 Versus Nevanac in Post Phacoemulsification
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': 'C414203', 'term': 'nepafenac'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'leopoldo.baiza@sophia.com.mx', 'phone': '52+ (33) 30 01 42 00', 'title': 'Leopoldo M Baiza-Duran MD, Clinical trials Director', 'organization': 'Laboratorios Sophia S.A. de C.V.'}, 'certainAgreement': {'otherDetails': 'All the information is confidential and exclusive property of the sponsor. Information can be revealed only to my staff and regulatory agencies or ethics committee.\n\nAll the information from this protocol is confidential and exclusive property of the sponsor, it can not be revealed without written consent from the sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was performed according to the clinical protocol.'}}, 'adverseEventsModule': {'timeFrame': 'Interval of 30 days of intervention in which adverse events could occur, included in the treatment period (January 2014-2015)', 'description': 'During the pharmacological intervention period, in each visit, the principal investigator asked information about adverse events:\n\n1. Serious or No serious\n2. Severity: mild, moderate, severe\n3. relation with study drug or not', 'eventGroups': [{'id': 'EG000', 'title': 'PRO-155', 'description': 'Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution\n\nPre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye\n\nMaintenance therapy: 1 drop 3 times a day for 30 days\n\nPRO-155: Pre-medication (before surgery) and maintenance treatment.', 'otherNumAtRisk': 73, 'otherNumAffected': 5, 'seriousNumAtRisk': 73, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Nevanac', 'description': 'Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension\n\nPre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye\n\nMaintenance therapy: 1 drop 3 times a day for 30 days\n\nNevanac: Pre-medication (before surgery) and maintenance treatment.', 'otherNumAtRisk': 75, 'otherNumAffected': 2, 'seriousNumAtRisk': 75, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'fall from their own height', 'notes': 'The mild adverse event does not have relationship with the study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cystoid macular edema', 'notes': 'This moderate adverse event does not relationship with the study drug. The clinically significant cystoid macular edema occurs after cataract surgery.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Traumatic corneal desepithelization', 'notes': 'This moderate event does not have relationship with the study drug. The patient presented an accidental ocular injure.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Posterior Capsular Rupture', 'notes': 'This mild adverse event does not relationship with the study drug. The posterior capsular rupture occurs after cataract surgery.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'viral conjunctivitis', 'notes': 'This severe adverse event does not have relationship with the study drug. This patient had hypothyroidism like concomitant disease, this clinical condition would be able to increase the risk to have an infectious disease.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inflammatory cells in the corneal endothelium', 'notes': 'This moderate adverse event does not have relationship with the study drug. The presence of inflammatory cells in the corneal endothelium is related to cataract surgery procedure.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'intraocular lens exchange', 'notes': 'This adverse event does not have relationship with the study drug. The reason of intraocular lens exchange was: error in the intraocular lens power calculation.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Rhegmatogenous retinal detachment', 'notes': 'This serious adverse event occurred during the systematic assessment. The event was not related with the pharmacological intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'central retinal artery occlusion', 'notes': 'This serious adverse event occurred during systematic assessment. The adverse event was not related with the pharmacological intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Cellularity in Anterior Chamber', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRO-155', 'description': 'Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution\n\nPre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye\n\nMaintenance therapy: 1 drop 3 times a day for 30 days\n\nPRO-155: Pre-medication (before surgery) and maintenance treatment.'}, {'id': 'OG001', 'title': 'Nevanac', 'description': 'Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension\n\nPre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye\n\nMaintenance therapy: 1 drop 3 times a day for 30 days\n\nNevanac: Pre-medication (before surgery) and maintenance treatment.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '64.2', 'groupId': 'OG000'}, {'value': '64.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 30', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000'], 'statisticalMethod': 'Pearson´s Chi-square test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'day 30', 'description': 'Change from Percentage of Cellularity in anterior chamber after 30 days of treatment.', 'unitOfMeasure': 'Percentage of Cellularity', 'reportingStatus': 'POSTED', 'populationDescription': 'Mexican patients patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.'}, {'type': 'PRIMARY', 'title': 'Flare in Anterior Chamber', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRO-155', 'description': 'Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution\n\nPre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye\n\nMaintenance therapy: 1 drop 3 times a day for 30 days\n\nPRO-155: Pre-medication (before surgery) and maintenance treatment.'}, {'id': 'OG001', 'title': 'Nevanac', 'description': 'Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension\n\nPre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye\n\nMaintenance therapy: 1 drop 3 times a day for 30 days\n\nNevanac: Pre-medication (before surgery) and maintenance treatment.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '31.4', 'groupId': 'OG000'}, {'value': '31.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 30', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'day 30', 'description': 'Percentage of Participants with flare in anterior chamber after 30 days of treatment', 'unitOfMeasure': 'Percentage of Participants with flare', 'reportingStatus': 'POSTED', 'populationDescription': 'Mexican patients patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Without Ocular Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRO-155', 'description': 'Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution\n\nPre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye\n\nMaintenance therapy: 1 drop 3 times a day for 30 days\n\nPRO-155: Pre-medication (before surgery) and maintenance treatment.'}, {'id': 'OG001', 'title': 'Nevanac', 'description': 'Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension\n\nPre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye\n\nMaintenance therapy: 1 drop 3 times a day for 30 days\n\nNevanac: Pre-medication (before surgery) and maintenance treatment.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000'}, {'value': '5.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 30', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'day 30', 'description': 'percentage of patients without pain, would be measured using the Visual Analog Pain Scale', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Mexican patients patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.'}, {'type': 'SECONDARY', 'title': 'Mean Aqueous Concentration of Intervention Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRO-155', 'description': 'Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution\n\nPre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye\n\nMaintenance therapy: 1 drop 3 times a day for 30 days\n\nPRO-155: Pre-medication (before surgery) and maintenance treatment.'}, {'id': 'OG001', 'title': 'Nevanac', 'description': 'Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension\n\nPre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye\n\nMaintenance therapy: 1 drop 3 times a day for 30 days\n\nNevanac: Pre-medication (before surgery) and maintenance treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '207.5', 'spread': '152.3', 'groupId': 'OG000'}, {'value': '314.4', 'spread': '146.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'before surgery', 'description': "a nurse was instructed to instill five drops of the research product into each patient's eye in the hour before surgery. The concentration of the drug was determined for aqueous humor sample (0.15 mL) with a 30-gauge needle on a TB syringe after completion of the paracentesis. The paracentesis was performed after first incision during the phacoemulsification.", 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'We enrolled patients of both sexes (aged \\>18 years) with a diagnosis of cataract according to the Lens Opacities Classification System III ≤ NC4, C4 and, P4 in one eye were eligible for enrollment. Eligible patients must have had a best-corrected visual acuity of 6/60 (20/200) Snellen score.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Epithelial Defects Detected With Fluorescein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRO-155', 'description': 'Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution\n\nPre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye\n\nMaintenance therapy: 1 drop 3 times a day for 30 days\n\nPRO-155: Pre-medication (before surgery) and maintenance treatment.'}, {'id': 'OG001', 'title': 'Nevanac', 'description': 'Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension\n\nPre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye\n\nMaintenance therapy: 1 drop 3 times a day for 30 days\n\nNevanac: Pre-medication (before surgery) and maintenance treatment.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '54.4', 'groupId': 'OG000'}, {'value': '78.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '32.5', 'groupId': 'OG000'}, {'value': '64.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000'}, {'value': '36.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 30', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'measurements will be made at days 1, 5, 7 and 30', 'description': 'The percentage of patients presenting epithelial defects with fluorescein staining will be evaluated', 'unitOfMeasure': 'percentage of patients with defects', 'reportingStatus': 'POSTED', 'populationDescription': 'Mexican patients patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Epithelial Defects Detected With Green Lissamine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRO-155', 'description': 'Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution\n\nPre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye\n\nMaintenance therapy: 1 drop 3 times a day for 30 days\n\nPRO-155: Pre-medication (before surgery) and maintenance treatment.'}, {'id': 'OG001', 'title': 'Nevanac', 'description': 'Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension\n\nPre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye\n\nMaintenance therapy: 1 drop 3 times a day for 30 days\n\nNevanac: Pre-medication (before surgery) and maintenance treatment.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '41.4', 'groupId': 'OG000'}, {'value': '67.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '21.6', 'groupId': 'OG000'}, {'value': '57.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 30', 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000'}, {'value': '28.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'measurements will be made at days 1, 5, 7 and 30', 'description': 'the percentage of patients presenting epithelial defects evaluated with green lysine will be reported', 'unitOfMeasure': 'percentage of patients with defects', 'reportingStatus': 'POSTED', 'populationDescription': 'Mexican patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Intraocular Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRO-155', 'description': 'Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution\n\nPre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye\n\nMaintenance therapy: 1 drop 3 times a day for 30 days\n\nPRO-155: Pre-medication (before surgery) and maintenance treatment.'}, {'id': 'OG001', 'title': 'Nevanac', 'description': 'Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension\n\nPre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye\n\nMaintenance therapy: 1 drop 3 times a day for 30 days\n\nNevanac: Pre-medication (before surgery) and maintenance treatment.'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '14.07', 'spread': '1.82', 'groupId': 'OG000'}, {'value': '14.23', 'spread': '1.90', 'groupId': 'OG001'}]}]}, {'title': 'Day 1', 'categories': [{'measurements': [{'value': '14.66', 'spread': '2.61', 'groupId': 'OG000'}, {'value': '15.83', 'spread': '2.77', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '14.13', 'spread': '1.97', 'groupId': 'OG000'}, {'value': '14.54', 'spread': '1.85', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '13.81', 'spread': '1.64', 'groupId': 'OG000'}, {'value': '13.91', 'spread': '2.03', 'groupId': 'OG001'}]}]}, {'title': 'Day 30', 'categories': [{'measurements': [{'value': '14.10', 'spread': '1.78', 'groupId': 'OG000'}, {'value': '13.77', 'spread': '1.97', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 30', 'description': 'Change from Baseline in the intraocular pressure after 30 days of treatment', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mexican patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Retinal Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRO-155', 'description': 'Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution\n\nPre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye\n\nMaintenance therapy: 1 drop 3 times a day for 30 days\n\nPRO-155: Pre-medication (before surgery) and maintenance treatment.'}, {'id': 'OG001', 'title': 'Nevanac', 'description': 'Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension\n\nPre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye\n\nMaintenance therapy: 1 drop 3 times a day for 30 days\n\nNevanac: Pre-medication (before surgery) and maintenance treatment.'}], 'classes': [{'title': 'field A1 day 0', 'categories': [{'measurements': [{'value': '247.24', 'spread': '32.90', 'groupId': 'OG000'}, {'value': '250.87', 'spread': '34.42', 'groupId': 'OG001'}]}]}, {'title': 'field A1 day 30', 'categories': [{'measurements': [{'value': '252.06', 'spread': '24.95', 'groupId': 'OG000'}, {'value': '264.08', 'spread': '34.10', 'groupId': 'OG001'}]}]}, {'title': 'field A1 day 60', 'categories': [{'measurements': [{'value': '254.06', 'spread': '2.78', 'groupId': 'OG000'}, {'value': '260.13', 'spread': '33.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 30 and 60', 'description': 'Change from Baseline in retinal thickness after 30 days of treatment. A third measurement will be done at 60 day after day surgery.', 'unitOfMeasure': 'μm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mexican patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PRO-155', 'description': 'Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution\n\nPre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye\n\nMaintenance therapy: 1 drop 3 times a day for 30 days\n\nPRO-155: Pre-medication (before surgery) and maintenance treatment.'}, {'id': 'FG001', 'title': 'Nevanac', 'description': 'Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension\n\nPre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye\n\nMaintenance therapy: 1 drop 3 times a day for 30 days\n\nNevanac: Pre-medication (before surgery) and maintenance treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': '160 subjects were recruited, 12 of whom were excluded, 10 because they did not meet the selection criteria and 2 refused to participate. The remaining 148 were randomly assigned to one of the 2 study groups, 73 to bromfenac and 75 to napaphenac.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PRO-155', 'description': 'Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution\n\nPre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye\n\nMaintenance therapy: 1 drop 3 times a day for 30 days\n\nPRO-155: Pre-medication (before surgery) and maintenance treatment.'}, {'id': 'BG001', 'title': 'Nevanac', 'description': 'Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension\n\nPre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye\n\nMaintenance therapy: 1 drop 3 times a day for 30 days\n\nNevanac: Pre-medication (before surgery) and maintenance treatment.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.4', 'spread': '11.1', 'groupId': 'BG000'}, {'value': '68.0', 'spread': '9.5', 'groupId': 'BG001'}, {'value': '67.7', 'spread': '10.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Mexico', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Mexican patients.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-08', 'studyFirstSubmitDate': '2012-07-19', 'resultsFirstSubmitDate': '2016-06-14', 'studyFirstSubmitQcDate': '2012-08-03', 'lastUpdatePostDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-08', 'studyFirstPostDateStruct': {'date': '2012-08-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Epithelial Defects Detected With Fluorescein', 'timeFrame': 'measurements will be made at days 1, 5, 7 and 30', 'description': 'The percentage of patients presenting epithelial defects with fluorescein staining will be evaluated'}, {'measure': 'Epithelial Defects Detected With Green Lissamine', 'timeFrame': 'measurements will be made at days 1, 5, 7 and 30', 'description': 'the percentage of patients presenting epithelial defects evaluated with green lysine will be reported'}, {'measure': 'Intraocular Pressure', 'timeFrame': 'day 30', 'description': 'Change from Baseline in the intraocular pressure after 30 days of treatment'}, {'measure': 'Retinal Thickness', 'timeFrame': 'day 30 and 60', 'description': 'Change from Baseline in retinal thickness after 30 days of treatment. A third measurement will be done at 60 day after day surgery.'}], 'primaryOutcomes': [{'measure': 'Percentage of Cellularity in Anterior Chamber', 'timeFrame': 'day 30', 'description': 'Change from Percentage of Cellularity in anterior chamber after 30 days of treatment.'}, {'measure': 'Flare in Anterior Chamber', 'timeFrame': 'day 30', 'description': 'Percentage of Participants with flare in anterior chamber after 30 days of treatment'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients Without Ocular Pain', 'timeFrame': 'day 30', 'description': 'percentage of patients without pain, would be measured using the Visual Analog Pain Scale'}, {'measure': 'Mean Aqueous Concentration of Intervention Drug', 'timeFrame': 'before surgery', 'description': "a nurse was instructed to instill five drops of the research product into each patient's eye in the hour before surgery. The concentration of the drug was determined for aqueous humor sample (0.15 mL) with a 30-gauge needle on a TB syringe after completion of the paracentesis. The paracentesis was performed after first incision during the phacoemulsification."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['bromfenac', 'nepafenac', 'cataract', 'phacoemulsification cataract surgery'], 'conditions': ['Cataract', 'Phacoemulsification Cataract Surgery']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4734805/pdf/opth-10-233.pdf', 'label': 'Palacio C, et al. Bromfenac 0.09% bioavailability in aqueous humor, prophylactic effect on cystoid macular edema, and clinical signs of ocular inflammation after phacoemulsification in a Mexican population. Clinical Ophthalmology 2016;10:233-237'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate efficacy and safety of the ophthalmic solution PRO-155 in patients post phacoemulsification.', 'detailedDescription': 'Postsurgical inflammation is an inevitable condition after cataract surgery. The use of non-steroidal anti-inflammatory drugs is a safe option for treating ocular inflammation.\n\nThis is a phase II randomized double-blind clinical trial. The aim is to compare and to evaluate efficacy and safety of two ophthalmic solutions in patients post phacoemulsification. Patients will be randomized to receive either PRO-155 or Nevanac for 60 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 18 years who require cataract surgery\n* Both genders\n* Provide informed consent\n* Normal Laboratory results\n\nExclusion Criteria:\n\n* Patients with visual acuity of 20/40 or less in the contralateral eye of the surgery\n* Patients with any trans-surgical complication\n* Patients with a cataract \\>NC4, C4 or P4 classified with the system LOCS\n* Patients with any active corneal pathology\n* Patients under any steroidal treatment (topic, systemic or inhaled)14 days prior surgery or NSAIDs 7 days before the surgery (except low-dose aspirin)\n* Patients with IOP \\<5 or \\>21 mmHg\n* Patients that have ocular pain, cellularity or flare at the moment of selection\n* Patients with ocular exfoliation, trauma or any inflammatory disease\n* Patients with diabetic retinopathy that need treatment or uncontrolled diabetes mellitus\n* Patients who are planning cataract surgery of the contralateral eye 14 days after surgery of the study eye\n* Patients with history of hypersensitivity or contraindication for any drug used in the study\n* Patients under anticoagulant treatment\n* Contact lens users\n* Pregnant patients, at risk of pregnancy or breastfeeding\n* Patients without birth control treatment\n* Patients with any active toxicomania (alcoholism, cigarette, cannabis or others)\n* Patients who had participated in any clinical trial in the last 90 days\n* Legal or mentally disabled patients who could not give informed consent\n* Patients who cannot comply with all study requirements'}, 'identificationModule': {'nctId': 'NCT01657266', 'briefTitle': 'Efficacy and Safety of PRO-155 Versus Nevanac in Post Phacoemulsification', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratorios Sophia S.A de C.V.'}, 'officialTitle': 'Phase 2 Randomized, Double-blind Clinical Trial to Evaluate Efficacy and Safety of the Ophthalmic Solution PRO-155 Versus Nevanac 0.1% Ophthalmic Solution in Post Phacoemulsification Patients', 'orgStudyIdInfo': {'id': 'SOPH155-0412/II'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRO-155', 'description': 'Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye\n\nMaintenance therapy: 1 drop 3 times a day for 30 days', 'interventionNames': ['Drug: PRO-155']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nevanac', 'description': 'Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension\n\nPre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye\n\nMaintenance therapy: 1 drop 3 times a day for 30 days', 'interventionNames': ['Drug: Nevanac']}], 'interventions': [{'name': 'PRO-155', 'type': 'DRUG', 'description': 'Pre-medication (before surgery) and maintenance treatment.', 'armGroupLabels': ['PRO-155']}, {'name': 'Nevanac', 'type': 'DRUG', 'description': 'Pre-medication (before surgery) and maintenance treatment.', 'armGroupLabels': ['Nevanac']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44280', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Hospital Civil de Guadalajara Fray Antonio Alcalde', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}], 'overallOfficials': [{'name': 'Leopoldo M. Baiza-Durán, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Laboratorios Sophia S.A de C.V.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The personal data were collected and analyzed according to confidentiality policy.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratorios Sophia S.A de C.V.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}