Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2025-12-29 @ 2:32 AM
Study NCT ID:
NCT05741632
Status:
COMPLETED
Last Update Posted:
2023-08-22
First Post:
2023-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Profile Comparison of Undiluted Intracameral Moxifloxacin vs. Levofloxacin in Cataract Surgery
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participant will be masked receiving treatment, post operative eye drops of both arms is the same. Subject allocation is blinded to investigator and outcomes assessor.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'First group will receive Moxifloxacin intracameral during surgery Second group will receive Levofloxacin intracameral during surgery'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-18', 'studyFirstSubmitDate': '2023-02-14', 'studyFirstSubmitQcDate': '2023-02-14', 'lastUpdatePostDateStruct': {'date': '2023-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endothelial cell density', 'timeFrame': '1 month', 'description': 'Corneal endothelial cell density measured using specular microscopy'}], 'secondaryOutcomes': [{'measure': 'Central corneal thickness', 'timeFrame': '1 month', 'description': 'Central corneal thickness (in nm) measured using specular microscopy'}, {'measure': 'Central macular thickness', 'timeFrame': '1 month', 'description': 'Central macular thickness (in nm) measure using optical coherence tomography'}, {'measure': 'Anterior chamber cell reactions', 'timeFrame': '1 month', 'description': 'Anterior chamber cell reactions measured in Standardization of Uveitis Nomenclature (SUN) grading. Values consist of 0, trace, 1+, 2+, 3+, and 4+. Higher grading score means more inflammatory reaction which is worse.'}, {'measure': 'Intraocular pressure', 'timeFrame': '1 month', 'description': 'Intraocular pressure (in mmHg) measured using automated non contact tonometer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Moxifloxacin', 'Levofloxacin', 'Cataract surgery'], 'conditions': ['Cataract']}, 'referencesModule': {'references': [{'pmid': '30691922', 'type': 'BACKGROUND', 'citation': 'Melega MV, Alves M, Cavalcanti Lira RP, Cardoso da Silva I, Ferreira BG, Assis Filho HL, Pedreira Chaves FR, Martini AAF, Dias Freire LM, Reis RD, Leite Arieta CE. Safety and efficacy of intracameral moxifloxacin for prevention of post-cataract endophthalmitis: Randomized controlled clinical trial. J Cataract Refract Surg. 2019 Mar;45(3):343-350. doi: 10.1016/j.jcrs.2018.10.044. Epub 2019 Jan 25.'}, {'pmid': '32050222', 'type': 'BACKGROUND', 'citation': "Chang DF, Prajna NV, Szczotka-Flynn LB, Benetz BA, Lass JH, O'Brien RC, Menegay HJ, Gardner S, Shekar M, Rajendrababu S, Rhee DJ. Comparative corneal endothelial cell toxicity of differing intracameral moxifloxacin doses after phacoemulsification. J Cataract Refract Surg. 2020 Mar;46(3):355-359. doi: 10.1097/j.jcrs.0000000000000064."}, {'pmid': '29846429', 'type': 'BACKGROUND', 'citation': 'Lucena NP, Pereira IMS, Gaete MIL, Ferreira KSA, Melega MV, Lira RPC. Intracameral moxifloxacin after cataract surgery: a prospective study. Arq Bras Oftalmol. 2018 Apr;81(2):92-94. doi: 10.5935/0004-2749.20180022.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this randomized clinical trial study is to compare safety profile undiluted intracameral moxifloxacin vs levofloxacin during cataract surgery. The main question it aims to answer is whether moxifloxacin and levofloxacin have similar safety profile.\n\nParticipant will be randomized into two treatment arms. All participant will receive standardized treatment before, during, and after surgery and will be followed up at one day, one week, and one month after surgery.', 'detailedDescription': 'This study aims to observe the safety profile in patient receiving cataract surgery who receives moxifloxacin and levofloxacin intracamerally during the surgery. Safety profile defined as visual acuity, intraocular pressure, corneal endothelial cell density, central corneal thickness, anterior chamber reactions, and central macular thickness. Parameters are obtained before the surgery, 1 day, 1 week, and 1 month after surgery. Subjects are randomized to two treatment arms: (1) receiving undiluted moxifloxacin 0.1 cc during surgery; (2) receiving undiluted levofloxacin 0.1 cc during surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Immature senile cataract in one or both eye\n* Agree to be included and signed informed consent\n\nExclusion Criteria:\n\n* Have a history of allergy to moxifloxacin or levofloxacin or any other antibiotics\n* Other ocular comorbid such as uveitis, glaucoma, diabetic retinopathy, pseudoexfoliation, and endothelial disorders\n* Ocular surgery prior to study\n* Sign of infection or inflammation around the eye\n* Cataract density more than grade 4 according to Lens Opacities Classification System (LOCS) III grading\n* Corneal endothelial cell density \\< 1500 cell/ mm2\n* Anterior chamber depth \\< 2.5 mm\n* Diabetes mellitus type 2'}, 'identificationModule': {'nctId': 'NCT05741632', 'briefTitle': 'Safety Profile Comparison of Undiluted Intracameral Moxifloxacin vs. Levofloxacin in Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'Safety Profile Comparison of Undiluted Intracameral Moxifloxacin vs. Levofloxacin in Cataract Surgery', 'orgStudyIdInfo': {'id': '22-10-1262'}, 'secondaryIdInfos': [{'id': 'KET-1303/UN2.F1/ETIK/PPM.00.02', 'type': 'OTHER', 'domain': 'Komite Etik Penelitian Kesehatan FKUI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Moxifloxacin', 'description': 'Subjects will receive 0.1 cc undiluted non preserved intracameral Moxifloxacin during cataract surgery.', 'interventionNames': ['Drug: Moxifloxacin Ophthalmic Solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Levofloxacin', 'description': 'Subjects will receive 0.1 cc undiluted non preserved intracameral Levofloxacin during cataract surgery.', 'interventionNames': ['Drug: Levofloxacin Ophthalmic']}], 'interventions': [{'name': 'Moxifloxacin Ophthalmic Solution', 'type': 'DRUG', 'otherNames': ['Molcin(R)'], 'description': 'Moxifloxacin solution 0.1 cc undiluted, self preserved, injected into intracamera at the end of cataract surgery', 'armGroupLabels': ['Moxifloxacin']}, {'name': 'Levofloxacin Ophthalmic', 'type': 'DRUG', 'otherNames': ['Cravit(R)'], 'description': 'Levofloxacin solution 0.1 cc undiluted, self preserved, injected into intracamera at the end of cataract surgery', 'armGroupLabels': ['Levofloxacin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta Pusat', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'Fakultas Kedokteran Universitas Indonesia', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}], 'overallOfficials': [{'name': 'Arcci Pradessatama, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RSCM Kirana'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ferron Par Pharmaceuticals', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ophthalmology Department Resident', 'investigatorFullName': 'Arcci Pradessatama', 'investigatorAffiliation': 'Indonesia University'}}}}