Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-01-10 @ 12:41 AM
Study NCT ID:
NCT00627302
Status:
COMPLETED
Last Update Posted:
2008-11-24
First Post:
2008-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of PEG-400 and Systane Artificial Tears (Alcon) on Quality of Vision
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000595213', 'term': 'polyethylene glycol 400'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-11', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-11-20', 'studyFirstSubmitDate': '2008-02-22', 'studyFirstSubmitQcDate': '2008-02-29', 'lastUpdatePostDateStruct': {'date': '2008-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of vision', 'timeFrame': '5 months'}], 'secondaryOutcomes': [{'measure': 'Efficacy', 'timeFrame': '5 months'}]}, 'conditionsModule': {'keywords': ['Quality of Vision'], 'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'To evaluate the effect of PEG-400 and Systane on quality of vision after LASIK.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females \\> 21 years old\n* Scheduled to undergo bilateral LASIK\n* Likely to complete all study visits and able to provide informed consent\n\nExclusion Criteria:\n\n* Prior or current use of topical cyclosporine within the last 1 year\n* Known contraindications to any study medication or ingredients\n* Ocular disorders\n* Active ocular diseases or uncontrolled systemic disease\n* Active ocular allergies\n* Complications at the time of surgery'}, 'identificationModule': {'nctId': 'NCT00627302', 'briefTitle': 'Efficacy of PEG-400 and Systane Artificial Tears (Alcon) on Quality of Vision', 'organization': {'class': 'NETWORK', 'fullName': 'Bp Consulting, Inc'}, 'orgStudyIdInfo': {'id': '5353'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Systane', 'interventionNames': ['Drug: Systane']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'PEG-400', 'interventionNames': ['Drug: PEG-400']}], 'interventions': [{'name': 'PEG-400', 'type': 'DRUG', 'description': 'Day of Surgery: Starting 2 hours after surgery Instill one drop in randomized eye every two hours. Day 1-Week 1: Instill one drop in randomized eye four times daily', 'armGroupLabels': ['1']}, {'name': 'Systane', 'type': 'DRUG', 'description': 'Day of Surgery: Starting 2 hours after surgery Instill one drop in randomized eye every two hours. Day 1-Week 1: Instill one drop in randomized eye four times daily', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11570', 'city': 'Rockville Centre', 'state': 'New York', 'country': 'United States', 'facility': 'Ophthalmic Consultants of long Island', 'geoPoint': {'lat': 40.65871, 'lon': -73.64124}}], 'overallOfficials': [{'name': 'Eric Donnenfeld, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ophthalmic Consultants of Long Island'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bp Consulting, Inc', 'class': 'NETWORK'}, 'responsibleParty': {'oldNameTitle': 'Eric Donnenfeld, MD', 'oldOrganization': 'Ophthalmic Consultants of Long Island'}}}}