Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2025-12-28 @ 9:01 PM
Study NCT ID:
NCT00904904
Status:
COMPLETED
Last Update Posted:
2012-08-13
First Post:
2009-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Indomethacin Eyedrops Compared With Ketorolac Eyedrops for Ocular Inflammation Following Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-10', 'studyFirstSubmitDate': '2009-05-19', 'studyFirstSubmitQcDate': '2009-05-19', 'lastUpdatePostDateStruct': {'date': '2012-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aqueous flare', 'timeFrame': 'Post-operative day 1 & day 7'}], 'secondaryOutcomes': [{'measure': 'Aqueous flare', 'timeFrame': 'Postoperative day 30 and day 90'}, {'measure': 'Change from baseline of retinal thickness', 'timeFrame': 'Postoperative day 30 & day 90'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cataract', 'Inflammation']}, 'descriptionModule': {'briefSummary': 'This study is being conducted to show that indomethacin is at least as effective as ketorolac for the prevention of ocular inflammation following cataract surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must be planning to undergo cataract surgery on one eye by phacoemulsification with posterior chamber intraocular lens, using topical or general anaesthesia.\n* Subjects must have a preoperative flare ≤ 15 ph/ms, measured with a laser flare meter(LFM) without pharmacological pupil dilation, within the 2 months preoperatively.\n\nExclusion Criteria:\n\n* Subjects who have any progressive pathology requiring the use of topical or systemic anti-inflammatory or anti-infectious agents.\n* Subjects who take acetylsalicylic acid at doses \\> 100 mg daily and cannot discontinue usage during the study.\n* Subjects who have a history of asthma linked to acetylsalicylic acid or other nonsteroidal anti-inflammatory (NSAI) drug administration.\n* Subjects with immunodepression.\n* Subjects with a history of intolerance to the study drug or to any NSAI drug.\n* Subjects who are monocular for any reason other than cataract.\n* Subjects who are treated with local or systemic anti-inflammatory drugs within 10 days prior to inclusion.'}, 'identificationModule': {'nctId': 'NCT00904904', 'briefTitle': 'Indomethacin Eyedrops Compared With Ketorolac Eyedrops for Ocular Inflammation Following Cataract Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch & Lomb Incorporated'}, 'orgStudyIdInfo': {'id': '539'}, 'secondaryIdInfos': [{'id': '2007-004686-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Indomethacin', 'description': 'Indomethacin ophthalmic solution 0.1% for post-surgical inflammation', 'interventionNames': ['Drug: Indomethacin ophthalmic solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ketorolac', 'description': 'Ketorolac ophthalmic solution 0.5% for post-surgical inflammation', 'interventionNames': ['Drug: Ketorolac Ophthalmic Solution']}], 'interventions': [{'name': 'Indomethacin ophthalmic solution', 'type': 'DRUG', 'description': 'Indomethacin 0.1% eye drops administered pre-cataract surgery and for 4 weeks post-cataract surgery', 'armGroupLabels': ['Indomethacin']}, {'name': 'Ketorolac Ophthalmic Solution', 'type': 'DRUG', 'description': 'Ketorolac 0.5% eye drops administered pre-cataract surgery and 4 weeks post-cataract surgery', 'armGroupLabels': ['Ketorolac']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D 13581', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Bausch & Lomb', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Gabriele Brenger', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bausch & Lomb Incorporated'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}