Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2026-02-24 @ 3:16 PM
Study NCT ID:
NCT04403334
Status:
COMPLETED
Last Update Posted:
2020-05-27
First Post:
2020-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Safety Outcomes of Intraoperative Intracameral Preservative-Free Moxifloxacin Versus Levofloxacin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009877', 'term': 'Endophthalmitis'}], 'ancestors': [{'id': 'D015817', 'term': 'Eye Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'unlabelled syringe containing interventional drug'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2018-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-21', 'studyFirstSubmitDate': '2020-05-21', 'studyFirstSubmitQcDate': '2020-05-21', 'lastUpdatePostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endothelial Cell Count', 'timeFrame': '3 months', 'description': 'Change in endothelial cell count as measured by specular microscopy'}, {'measure': 'Central Retina Thickness', 'timeFrame': '3 months', 'description': 'Change in central retinal thickness as measured by spectral domain optical coherence tomography'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '3 months', 'description': 'Onset of Adverse events following intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['levofloxacin', 'moxifloxacin', 'prophylaxis', 'endophthalmitis', 'cataract surgery'], 'conditions': ['Cataract Senile', 'Endophthalmitis', 'Antibiotic Side Effect', 'Safety Issues']}, 'descriptionModule': {'briefSummary': 'Comparative safety study of intracameral levofloxacin versus moxifloxacin for postoperative infection prophylaxis', 'detailedDescription': 'Randomized clinical trial comparing corneal and retinal changes after intracameral levofloxacin or moxifloxacin administered at the end of surgery among eyes undergoing uncomplicated phacoemulsification.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eyes undergoing uncomplicated cataract surgery by phacoemulsification\n\nExclusion Criteria:\n\n* Corneal opacities, corneal dystrophies, glaucoma, uveitis, retinopathy, optic neuropathy, concomitant infection (blepharitis, hordeolum, or conjunctivitis) or uncontrolled systemic disease and intraoperative complications that may affect visual outcomes were excluded from the study'}, 'identificationModule': {'nctId': 'NCT04403334', 'briefTitle': 'Postoperative Safety Outcomes of Intraoperative Intracameral Preservative-Free Moxifloxacin Versus Levofloxacin', 'organization': {'class': 'OTHER', 'fullName': 'Peregrine Eye and Laser Institute'}, 'officialTitle': 'Postoperative Safety Outcomes in Patients Undergoing Routine Phacoemulsification Cataract Surgery With Intraoperative Intracameral Injection of Preservative-Free Moxifloxacin Versus Levofloxacin', 'orgStudyIdInfo': {'id': '20180101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intracameral levofloxacin', 'description': '0.5% unpreserved solution', 'interventionNames': ['Drug: Levofloxacin Ophthalmic']}, {'type': 'EXPERIMENTAL', 'label': 'Intracameral moxifloxacin', 'description': '0.5% unpreserved solution', 'interventionNames': ['Drug: Moxifloxacin Ophthalmic']}], 'interventions': [{'name': 'Levofloxacin Ophthalmic', 'type': 'DRUG', 'description': '0.1 ml of unpreserved 0.5% levofloxacin', 'armGroupLabels': ['Intracameral levofloxacin']}, {'name': 'Moxifloxacin Ophthalmic', 'type': 'DRUG', 'description': '0.1 ml of unpreserved 0.5% moxifloxacin', 'armGroupLabels': ['Intracameral moxifloxacin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1209', 'city': 'Makati City', 'state': 'MM', 'country': 'Philippines', 'facility': 'Peregrine Eye and Laser Instittute', 'geoPoint': {'lat': 14.55027, 'lon': 121.03269}}], 'overallOfficials': [{'name': 'Harvey S Uy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peregrine Eye and Laser Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peregrine Eye and Laser Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director', 'investigatorFullName': 'Harvey Siy Uy', 'investigatorAffiliation': 'Peregrine Eye and Laser Institute'}}}}