Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-31 @ 1:33 AM
Study NCT ID:
NCT00347503
Status:
COMPLETED
Last Update Posted:
2007-07-13
First Post:
2006-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aqueous Concentrations and PGE2 Inhibition of Ketorolac 0.4% vs. Bromfenac 0.09% in Cataract Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D020910', 'term': 'Ketorolac'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-07', 'lastUpdateSubmitDate': '2007-07-12', 'studyFirstSubmitDate': '2006-06-29', 'studyFirstSubmitQcDate': '2006-06-29', 'lastUpdatePostDateStruct': {'date': '2007-07-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-04', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'Evaluation of the aqueous concentrations of 2 topical NSAIDS as well as the PGE2 inhibition in human patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy Male/Female 21 years of age of older.\n* Patient understands and is willing to sign the written informed consent form\n* Likely to complete the entire course of the study.\n* Patient is scheduled to undergo cataract surgery\n* Female patients of childbearing potential must have had a regular menstrual cycle prior to study entry (a female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation).\n* Patient is willing and able to administer eye drops and record the times the drops were instilled\n\nExclusion Criteria:\n\n* Patient has been using a topical NSAID within 1 week of study entry\n* Patient has a known sensitivity to any of the ingredients in the study medications\n* Patient has sight in only one eye\n* Patient has a history of previous intraocular surgery\n* Patient's doctor has determined they have a condition (i.e., UNCONTROLLED systemic disease) or are in a situation that may put them at significant risk, confound the study results or may interfere significantly with their participation in the study\n* Female patients who are pregnant, nursing an infant or planning a pregnancy\n* Patients who are currently involved in another investigational study or have participated in one within the 30 days prior to entering this study"}, 'identificationModule': {'nctId': 'NCT00347503', 'briefTitle': 'Aqueous Concentrations and PGE2 Inhibition of Ketorolac 0.4% vs. Bromfenac 0.09% in Cataract Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Innovative Medical'}, 'officialTitle': 'Aqueous Concentrations and PGE2 Inhibition of Ketorolac 0.4% vs. Bromfenac 0.09% in Cataract Patients', 'orgStudyIdInfo': {'id': 'B2601'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ketorolac 0.4%, bromfenac 0.09%', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '18702', 'city': 'Wilkes-Barre', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Bucci Laser Vision', 'geoPoint': {'lat': 41.24591, 'lon': -75.88131}}], 'overallOfficials': [{'name': 'Frank Bucci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bucci Vision Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innovative Medical', 'class': 'INDUSTRY'}}}}