Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2025-12-26 @ 4:13 PM
Study NCT ID:
NCT00357292
Status:
COMPLETED
Last Update Posted:
2006-07-27
First Post:
2006-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ocular Tolerance, Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5, 1.0, 1.5% in 48 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': '2002-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-07', 'completionDateStruct': {'date': '2002-04'}, 'lastUpdateSubmitDate': '2006-07-26', 'studyFirstSubmitDate': '2006-07-25', 'studyFirstSubmitQcDate': '2006-07-26', 'lastUpdatePostDateStruct': {'date': '2006-07-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular subjective symptoms'}, {'measure': 'Ocular objective symptoms'}], 'secondaryOutcomes': [{'measure': 'Ocular pharmacokinetic.'}, {'measure': 'Ocular and systemic adverse events.'}]}, 'conditionsModule': {'conditions': ['Eye Infections, Bacterial']}, 'descriptionModule': {'briefSummary': 'To compare the ocular tolerance, the safety and the ocular pharmacokinetics of 3 concentrations (0.5% - 1.0% - 1.5%) and the vehicle of T1225 after one drop instillation', 'detailedDescription': 'The aim of the present study was to compare the ocular tolerance, safety and the ocular pharmacokinetics after a single administration of T1225 eye drops (0.5%, 1.0%, or 1.5%) in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged from 18 to 45 years old;\n* Written informed consent;\n* Healthy volunteers (without any ocular symptom);\n* Normal ocular examination in both eyes (corrected visual acuity (VA) \\>= 6/10 - Slit lamp examination without clinical relevant abnormalities - Tear break-up time (BUT) ≥10 seconds - Lachrymal secretion in the Schirmer test \\>= 10 mm in 5 minutes - Lissamine green test total score \\< 4 +).\n\nExclusion Criteria:\n\n* Ocular trauma, infection or inflammation within the last 3 months;\n* Blepharitis;\n* Conjunctival hyperaemia (score \\>= 2 +);\n* Watering (score \\>= 2);\n* Contact lenses;\n* Ocular surgery, including LASIK and PRK, within the last 12 months;\n* Topical ocular treatment within the last month;\n* Systemic antibiotics within the last 7 days;\n* Any medication during the study (except: Paracetamol and contraceptives).'}, 'identificationModule': {'nctId': 'NCT00357292', 'briefTitle': 'Ocular Tolerance, Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5, 1.0, 1.5% in 48 Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoires Thea'}, 'officialTitle': 'Comparison of the Ocular Tolerance, the Safety and the Ocular Pharmacokinetics After One Drop of Three Different Concentrations of T1225 (0.5% - 1.0% - 1.5%) in 48 Healthy Volunteers', 'orgStudyIdInfo': {'id': 'LT1225-PI1-09/01(AS)'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Azithromycin (T1225)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Khalid TABBARA, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Eye Center, Riyadh (Saudi Arabia)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoires Thea', 'class': 'INDUSTRY'}}}}