Ignite Creation Date:
2025-12-24 @ 12:48 PM
Ignite Modification Date:
2026-01-02 @ 3:11 PM
Study NCT ID:
NCT01021761
Status:
COMPLETED
Last Update Posted:
2011-08-31
First Post:
2009-11-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)in Patients Undergoing Phacoemulsification
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020911', 'term': 'Ketorolac Tromethamine'}, {'id': 'D020910', 'term': 'Ketorolac'}, {'id': 'C053083', 'term': 'bromfenac'}, {'id': 'C414203', 'term': 'nepafenac'}], 'ancestors': [{'id': 'D007213', 'term': 'Indomethacin'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Buccivision@aol.com', 'phone': '570-825-5949', 'title': 'Frank A. Bucci, Jr., MD', 'organization': 'Bucci Laser Vision'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Xibrom', 'description': 'Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery', 'otherNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Nevanac', 'description': 'Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery', 'otherNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Acuvail', 'description': 'Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery.', 'otherNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Aqueous PGE2 Inhibition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Xibrom', 'description': 'Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery'}, {'id': 'OG001', 'title': 'Nevanac', 'description': 'Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery'}, {'id': 'OG002', 'title': 'Acuvail', 'description': 'Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '288.7', 'spread': '226.05', 'groupId': 'OG000'}, {'value': '320.4', 'spread': '205.6', 'groupId': 'OG001'}, {'value': '224.8', 'spread': '164.87', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 4 of treatment', 'description': 'A spectroscopic quantification of PGE2 was performed on the aqueous humor samples collected with the results measured in pg/ml. PGE2 levels below 50 pg/ml were considered below the level of detection.', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Protocol specified 126 subjects to be enrolled and analysis was performed per protocol.', 'anticipatedPostingDate': '2011-05'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Xibrom', 'description': 'Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery'}, {'id': 'FG001', 'title': 'Nevanac', 'description': 'Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery'}, {'id': 'FG002', 'title': 'Acuvail', 'description': 'Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '126', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Xibrom', 'description': 'Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery'}, {'id': 'BG001', 'title': 'Nevanac', 'description': 'Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery'}, {'id': 'BG002', 'title': 'Acuvail', 'description': 'Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery.'}, {'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': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72', 'spread': '31', 'groupId': 'BG000'}, {'value': '74', 'spread': '29', 'groupId': 'BG001'}, {'value': '75', 'spread': '30', 'groupId': 'BG002'}, {'value': '74', 'spread': '29', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '126', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-26', 'studyFirstSubmitDate': '2009-11-25', 'resultsFirstSubmitDate': '2011-05-25', 'studyFirstSubmitQcDate': '2009-11-27', 'lastUpdatePostDateStruct': {'date': '2011-08-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-28', 'studyFirstPostDateStruct': {'date': '2009-11-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aqueous PGE2 Inhibition', 'timeFrame': 'Day 4 of treatment', 'description': 'A spectroscopic quantification of PGE2 was performed on the aqueous humor samples collected with the results measured in pg/ml. PGE2 levels below 50 pg/ml were considered below the level of detection.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cataracts']}, 'descriptionModule': {'briefSummary': 'Approximately 126 subjects scheduled to undergo cataract surgery by phacoemulsification, will be randomized in an even allocation (1:1:1) to either Acuvail, Xibrom or Nevanac. Subjects will be instructed to begin dosing the study medication in the operative eye the day before surgery and continue dosing on the day of surgery. Beginning one hour before surgery 1 drop of study medication will be instilled by operating room staff approximately every 15 minutes for a total of 3 doses. At the designated time a paracentesis will be performed at the start of the cataract procedure and at least 0.15cc of aqueous humor will be collected. The sample will be immediately stored on dry ice and shipped to a laboratory for analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must be 18 years of age or older\n* Scheduled for cataract surgery by phacoemulsification\n* Subjects must be willing to comply with all study requirements and be willing to give informed consent\n\nExclusion Criteria:\n\n* Any subject that has a history of uveitis or active iritis\n* Subject can have o previous eye surgery with the exception of refractive surgery but not within 6 month\n* No ocular use of prostaglandins within 2 weeks of surgery\n* Use of oral, injectable or topical ophthalmic steroids, NSAIDs of immunosuppressants within 14 days prior to surgery\n* Contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs)\n* Active ocular infection'}, 'identificationModule': {'nctId': 'NCT01021761', 'briefTitle': 'A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)in Patients Undergoing Phacoemulsification', 'organization': {'class': 'OTHER', 'fullName': 'Bucci Laser Vision Institute'}, 'officialTitle': 'A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail, Xibrom and Nevanac in Patients Undergoing Phacoemulsification', 'orgStudyIdInfo': {'id': '2009 0199'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Xibrom', 'description': 'Xibrom to be given 1 drop 2 times (BID) the day before surgery and 3 doses pre op the day of surgery prior to surgery', 'interventionNames': ['Drug: Bromfenac']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nevanac', 'description': 'Nevanac to be given 1 drop 2 times (BID) the day before surgery and 3 doses pre op the day of surgery prior to surgery', 'interventionNames': ['Drug: nepafenac']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Acuvail', 'description': 'Acuvail to be given preoperatively. One drop 2 times (BID), 1 day pre op and day of surgery 3 doses prior to surgery.', 'interventionNames': ['Drug: Ketorolac Tromethamine']}], 'interventions': [{'name': 'Ketorolac Tromethamine', 'type': 'DRUG', 'otherNames': ['Acuvail'], 'description': 'ketorolac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery', 'armGroupLabels': ['Acuvail']}, {'name': 'Bromfenac', 'type': 'DRUG', 'otherNames': ['Xibrom'], 'description': 'Drug to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery', 'armGroupLabels': ['Xibrom']}, {'name': 'nepafenac', 'type': 'DRUG', 'otherNames': ['Nevanac'], 'description': 'drug to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery', 'armGroupLabels': ['Nevanac']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Frank A Bucci, Jr., MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bucci Laser Vision'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Frank A. Bucci, Jr., M.D.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Allergan', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Medical Director', 'investigatorFullName': 'Frank A. Bucci, Jr., M.D.', 'investigatorAffiliation': 'Bucci Laser Vision Institute'}}}}