Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-30 @ 9:03 PM
Study NCT ID:
NCT00817557
Status:
UNKNOWN
Last Update Posted:
2009-01-06
First Post:
2009-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Loteprednol for Contact Lens Intolerance and Dryness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2010-11-04', 'releaseDate': '2010-10-05'}], 'estimatedResultsFirstSubmitDate': '2010-10-05'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069559', 'term': 'Loteprednol Etabonate'}], 'ancestors': [{'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2009-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-01-05', 'studyFirstSubmitDate': '2009-01-02', 'studyFirstSubmitQcDate': '2009-01-05', 'lastUpdatePostDateStruct': {'date': '2009-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wearing time', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'OSDI', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Contact lenses', 'Loteprednol', 'Effect on CL dryness'], 'conditions': ['Contact Lenses Dryness']}, 'descriptionModule': {'briefSummary': 'Study of the effects of Loteprednol on CL dryness'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Between the ages of 18 and over inclusive.\n2. Males or females\n3. Any race or ethnic background\n4. CL history- experienced intolerance and either switched solutions or lenses without satisfactory relief.\n5. Patient is in generally good \\& stable overall health.\n6. Patient likely to comply with study guidelines \\& study visits.\n7. Informed consent signed.\n8. OSDI score 18 or higher while wearing lenses\n9. Unsatisfactory wearing time with contact lenses\n\nExclusion Criteria:\n\n1. Corneal refractive surgery within 6 months of this study.\n2. Contact lens use on day of examination.\n3. Corneal ectasia.\n4. Current use of Restasis\n5. Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.\n6. Pregnant or lactating women.\n7. Ocular pathology (includes glaucoma and cataract) which could impact results and/or place patient at risk.'}, 'identificationModule': {'nctId': 'NCT00817557', 'briefTitle': 'Use of Loteprednol for Contact Lens Intolerance and Dryness', 'organization': {'class': 'INDIV', 'fullName': 'Hom, Milton M., OD, FAAO'}, 'officialTitle': 'Use of Loteprednol for Contact Lens Intolerance and Dryness', 'orgStudyIdInfo': {'id': '05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Loteprednol', 'description': 'Loteprednol BID', 'interventionNames': ['Drug: Loteprednol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Rewetter', 'description': 'Rewetter BID', 'interventionNames': ['Other: Rewetter']}], 'interventions': [{'name': 'Loteprednol', 'type': 'DRUG', 'description': 'Anti-inflammatory', 'armGroupLabels': ['Loteprednol']}, {'name': 'Rewetter', 'type': 'OTHER', 'armGroupLabels': ['Rewetter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91702', 'city': 'Azusa', 'state': 'California', 'country': 'United States', 'facility': 'Milton M. Hom, OD, FAAO.', 'geoPoint': {'lat': 34.13362, 'lon': -117.90756}}], 'overallOfficials': [{'name': 'Milton M Hom, OD FAAO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Private Practice'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hom, Milton M., OD, FAAO', 'class': 'INDIV'}, 'collaborators': [{'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Milton M. Hom, OD, FAAO.', 'oldOrganization': 'Private Practice'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2010-10-05', 'type': 'RELEASE'}, {'date': '2010-11-04', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Private Practice (Milton M. Hom, OD, FAAO.)'}}}}