Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2026-01-04 @ 4:40 AM
Study NCT ID:
NCT00620893
Status:
COMPLETED
Last Update Posted:
2009-09-21
First Post:
2008-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bilateral, Masked Comparison of PEG-400 Based Artificial Tear vs. Systane for Dry Eye Signs, Symptoms & Refractive Regression Associated With Myopic Laser in Situ Keratomilieusis (LASIK).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-17', 'studyFirstSubmitDate': '2008-02-11', 'studyFirstSubmitQcDate': '2008-02-20', 'lastUpdatePostDateStruct': {'date': '2009-09-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'dry eye signs', 'timeFrame': '9 months'}], 'secondaryOutcomes': [{'measure': 'refractive regression', 'timeFrame': '9 months'}]}, 'conditionsModule': {'keywords': ['Dry eye signs and symptoms', 'refractive regression'], 'conditions': ['Dry Eye Syndromes']}, 'descriptionModule': {'briefSummary': "This study will evaluate and compare 2 artificial tears in their ability to reduce post LASIK dry eye signs and symptoms. The secondary endpoint of this study is to evaluate refractive regression in these patients. The 'Refractive Outcome' data point will be defined as the difference between the post-op spherical equivalent (SE) and the pre-op targeted SE."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ranging from normal to mild dry eye per physician assessment\n* BCVA of 20/20\n* Moderate to high myopia (-3 D to -10D of sphere)\n* Patients who are scheduled to under go myopic bilateral LASIK with VISX laser\n\nExclusion Criteria:\n\n* Patients currently using topical cyclosporine\n* Patients currently using Systane\n* Patients currently using an oil-based artificial tear such as Soothe or Endura\n* Any post-op epithelial defects or flap complications requiring further procedures (relifting, scraping, stretching etc.)\n* DLK greater than stage 1 or infectious keratitis post-operatively\n* Any uncontrolled systemic disease that may confound the results of this trial (Diabetes, Lupus, Rheumatoid Arthritis etc.)\n* Anisometropia greater than 1D'}, 'identificationModule': {'nctId': 'NCT00620893', 'briefTitle': 'Bilateral, Masked Comparison of PEG-400 Based Artificial Tear vs. Systane for Dry Eye Signs, Symptoms & Refractive Regression Associated With Myopic Laser in Situ Keratomilieusis (LASIK).', 'organization': {'class': 'NETWORK', 'fullName': 'Bp Consulting, Inc'}, 'orgStudyIdInfo': {'id': '5339'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': '1\\. PEG-400 based artificial tear', 'interventionNames': ['Drug: PEG- 400 based artificial tear']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': '2\\. Systane', 'interventionNames': ['Drug: Systane']}], 'interventions': [{'name': 'PEG- 400 based artificial tear', 'type': 'DRUG', 'description': 'Baseline: Instill one drop in the randomized eye four times daily starting the day after surgery can be used more frequently if needed Month 3: Instill one drop in the randomized eye twice daily', 'armGroupLabels': ['1']}, {'name': 'Systane', 'type': 'DRUG', 'description': 'Baseline: Instill one drop in the randomized eye four times daily starting the day after surgery can be used more frequently if needed Month 3: Instill one drop in the randomized eye twice daily', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Christopher Starr, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bp Consulting, Inc', 'class': 'NETWORK'}, 'responsibleParty': {'oldNameTitle': 'Dr. Christopher Starr', 'oldOrganization': 'Weill Cornell Medical Center'}}}}