Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-27 @ 8:09 AM
Study NCT ID:
NCT04542759
Status:
COMPLETED
Last Update Posted:
2020-09-09
First Post:
2020-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Topical Besifloxacin on Ocular Surface Bacterial Microbiota Prior to Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-02', 'studyFirstSubmitDate': '2020-08-19', 'studyFirstSubmitQcDate': '2020-09-02', 'lastUpdatePostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of positive cultures before and after treatment in each arm', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'A conjunctival cul-de-sac sample will be taken before starting treatment and before surgery, which will be cultured on 3 different media types: Blood, Chocolate and Sabouraud agar.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Besifloxacin', 'prophylaxis', 'cataract surgery'], 'conditions': ['Microbial Disease', 'Cataract Senile']}, 'descriptionModule': {'briefSummary': 'Describe the efficacy of the use of topical besifloxacin in reducing the conjunctival microbiota as a prophylactic measure in patients scheduled for cataract surgery.', 'detailedDescription': 'Randomized double-blind clinical trial. Study carried out in a single center between January and April 2017. 60 eyes were included that were randomly divided in a 1: 1 ratio into two groups. The first group received placebo (hydroxypropylmethylcellulose drops) while the second group received 0.6% besifloxacin drops four times a day for 3 days. All of them had a conjunctival cul-de-sac culture before and after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects over 18 years of age scheduled for cataract surgery in the established study period.\n* Subjects physically and mentally capable of applying the eye drops or having a person available to help in the correct administration of the eye drops 4 times a day.\n\nExclusion Criteria:\n\n* \\- Active eye infection (bacterial, viral, fungal or parasitic) such as blepharitis and / or conjunctivitis.\n* Known allergy or any contraindication to the use of quinolones or any of the components of the drugs.'}, 'identificationModule': {'nctId': 'NCT04542759', 'briefTitle': 'Effect of Topical Besifloxacin on Ocular Surface Bacterial Microbiota Prior to Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Oftalmología Fundación Conde de Valenciana'}, 'officialTitle': 'Effect of Topical Besifloxacin on Ocular Surface Bacterial Microbiota Prior to Cataract Surgery', 'orgStudyIdInfo': {'id': 'CI-004-215'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Besifloxacin', 'description': '1 DROP 4 TIMES A DAY FOR 3 DAYS PRIOR SURGERY', 'interventionNames': ['Drug: Besifloxacin Ophthalmic']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Hydroxypropyl methylcellulose', 'description': '1 DROP 4 TIMES A DAY FOR 3 DAYS PRIOR SURGERY', 'interventionNames': ['Drug: Hydroxypropyl Methylcellulose Ophthalmic Ophthalmic Solution']}], 'interventions': [{'name': 'Besifloxacin Ophthalmic', 'type': 'DRUG', 'otherNames': ['Besivance ophthalmic suspension 0.6%'], 'description': 'Prophylaxis for endophthalmitis', 'armGroupLabels': ['Besifloxacin']}, {'name': 'Hydroxypropyl Methylcellulose Ophthalmic Ophthalmic Solution', 'type': 'DRUG', 'otherNames': ['Artelac eye drops'], 'description': 'Placebo', 'armGroupLabels': ['Hydroxypropyl methylcellulose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06800', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Institute of Ophthalmology, Conde de Valenciana Foundation', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Eduardo Chavez-Mondragon, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Instutute of Ophthalmology "Conde de Valenciana"'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Oftalmología Fundación Conde de Valenciana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}