Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT00333203
Status:
COMPLETED
Last Update Posted:
2012-03-05
First Post:
2006-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Next Generation Ophthalmic Irrigating Solution Posterior Segment Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D019773', 'term': 'Epiretinal Membrane'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C013003', 'term': 'glutathione-bicarbonate-Ringer solution'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 369}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-01', 'studyFirstSubmitDate': '2006-06-01', 'studyFirstSubmitQcDate': '2006-06-01', 'lastUpdatePostDateStruct': {'date': '2012-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best-corrected logMAR visual acuity'}], 'secondaryOutcomes': [{'measure': 'Intraocular pressure (IOP)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['epimacular membrane'], 'conditions': ['Eye Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety of Next Generation Ophthalmic Irrigating Solution (NGOIS) compared to BSS PLUS for use during surgery for removal of epimacular membrane and vitrectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of any race and sex, with an epimacular membrane who would benefit from vitrectomy and membrane removal.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Under 18 years of age.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00333203', 'briefTitle': 'Next Generation Ophthalmic Irrigating Solution Posterior Segment Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Clinical Evaluation of the Safety of Next Generation Ophthalmic Irrigating Solution Compared to BSS Plus for Use During Surgery for Removal of Epimacular Membrane and Vitrectomy', 'orgStudyIdInfo': {'id': 'C-04-18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NGOIS', 'interventionNames': ['Drug: Next Generation Ophthalmic Irrigating Solution (NGOIS)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BSS Plus', 'interventionNames': ['Other: BSS Plus']}], 'interventions': [{'name': 'Next Generation Ophthalmic Irrigating Solution (NGOIS)', 'type': 'DRUG', 'description': 'Volume sufficient to irrigate adequately during cataract surgery', 'armGroupLabels': ['NGOIS']}, {'name': 'BSS Plus', 'type': 'OTHER', 'description': 'Volume sufficient to irrigate adequately during cataract surgery', 'armGroupLabels': ['BSS Plus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76134', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'United States', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}