Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-31 @ 1:10 AM
Study NCT ID:
NCT00356850
Status:
COMPLETED
Last Update Posted:
2006-07-26
First Post:
2006-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ocular Pharmacokinetics After a Single Drop Instillation of T1225 0.5, 1, 1.5% in 91 Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015818', 'term': 'Eye Infections, Bacterial'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015817', 'term': 'Eye Infections'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017963', 'term': 'Azithromycin'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-07', 'completionDateStruct': {'date': '2002-06'}, 'lastUpdateSubmitDate': '2006-07-25', 'studyFirstSubmitDate': '2006-07-25', 'studyFirstSubmitQcDate': '2006-07-25', 'lastUpdatePostDateStruct': {'date': '2006-07-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve from 0 to 24 hours (AUC0-24h)'}, {'measure': 'Elimination half-life (t1/2)'}, {'measure': 'Maximum Concentration (Cmax)'}, {'measure': 'Concentration 24 hours after instillation (C24h)'}], 'secondaryOutcomes': [{'measure': 'Tolerance'}]}, 'conditionsModule': {'conditions': ['Eye Infections, Bacterial']}, 'descriptionModule': {'briefSummary': 'To evaluate azithromycin tear concentrations after instillation of one drop of one of the three T1225 concentrations (0.5%, 1% and 1.5%) and to evaluate the ocular safety.', 'detailedDescription': 'The aim of the present study was to compare azithromycin tear ocular concentrations after a single instillation of three different T1225 concentrations in order to determine early azithromycin tear concentration and to assess the T1225 concentration, which allowed having the higher azithromycin tear concentration, 24 hours after a single instillation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male/female aged from 18 to 45 years;\n* Written informed consent;\n* Healthy volunteers without any subjective ocular symptom;\n* Corrected visual acuity \\>= 6/10;\n* Registered in the national register of healthy volunteers\n\nExclusion Criteria:\n\n* Ocular trauma, infection or inflammation within the last 3 months;\n* Conjunctival hyperaemia (score \\>= 2);\n* Folliculo-papillary conjunctivitis (score \\>= 2);\n* Topical ocular treatment within the last month;\n* Ocular surgery, including LASIK and PRK, within the last 12 months;\n* Other ocular laser within the last 3 months;\n* Zithromax® and Azadose® within the last 3 months;\n* Medication during the study (except: paracetamol, contraceptives'}, 'identificationModule': {'nctId': 'NCT00356850', 'briefTitle': 'Ocular Pharmacokinetics After a Single Drop Instillation of T1225 0.5, 1, 1.5% in 91 Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoires Thea'}, 'officialTitle': 'Ocular Pharmacokinetics After a Single Drop Instillation, in Each Eye of One of Three Different Concentrations of T1225 (0.5% - 1% - 1.5% Dihydrate) in 91 Healthy Volunteers', 'orgStudyIdInfo': {'id': 'LT1225-PI2-03/02(F)'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Azithromycin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Claude DUBRAY, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre de Pharmacologie Clinique - Clermont-Ferrand (France)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoires Thea', 'class': 'INDUSTRY'}}}}