Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2026-01-08 @ 5:49 AM
Study NCT ID:
NCT01854905
Status:
COMPLETED
Last Update Posted:
2014-03-14
First Post:
2013-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Observational Study of Dry Eye Prior to Laser-Assisted in Situ Keratomileusis (LASIK) Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Vice President Medical Affairs,', 'organization': 'Allergan, Inc'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Adverse events (AEs) and serious adverse events (SAEs) were not collected in this single day study, as no treatment was administered.', 'eventGroups': [{'id': 'EG000', 'title': 'Patients Attending Consultation for LASIK', 'description': 'Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients in Each Category of the Dry Eye Workshop Severity (DEWS) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '400', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Attending Consultation for LASIK', 'description': 'Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.'}], 'classes': [{'title': 'Mild and/or episodic, occurs under stress', 'categories': [{'measurements': [{'value': '65.0', 'spread': '25.97', 'groupId': 'OG000'}]}]}, {'title': 'Moderate episodic or chronic, stress or no stress', 'categories': [{'measurements': [{'value': '29.0', 'groupId': 'OG000'}]}]}, {'title': 'Severe frequent or constant without stress', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}]}]}, {'title': 'Data unavailable', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': "The severity of each patient's dry eye was classified by the physician according to the DEWS scale. Categories are: mild and/or episodic, occurs under environmental stress; moderate episodic or chronic, stress or no stress; and severe frequent or constant without stress", 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients Attending Consultation for LASIK', 'description': 'Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '400'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '400'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '400', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients Attending Consultation for LASIK', 'description': 'Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.7', 'spread': '9.97', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '263', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '137', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-28', 'studyFirstSubmitDate': '2013-05-14', 'resultsFirstSubmitDate': '2014-01-28', 'studyFirstSubmitQcDate': '2013-05-14', 'lastUpdatePostDateStruct': {'date': '2014-03-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-01-28', 'studyFirstPostDateStruct': {'date': '2013-05-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients in Each Category of the Dry Eye Workshop Severity (DEWS) Scale', 'timeFrame': 'Day 1', 'description': "The severity of each patient's dry eye was classified by the physician according to the DEWS scale. Categories are: mild and/or episodic, occurs under environmental stress; moderate episodic or chronic, stress or no stress; and severe frequent or constant without stress"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dry Eye Syndromes']}, 'descriptionModule': {'briefSummary': 'This is an observational, study of dry eye in patients at the consultation visit prior to LASIK surgery. There is no treatment administered or intervention during the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients consulting with ophthalmologist for possible LASIK', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Attending an ophthalmology consultation for LASIK\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01854905', 'briefTitle': 'An Observational Study of Dry Eye Prior to Laser-Assisted in Situ Keratomileusis (LASIK) Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': 'MAF-AGN-OPH-DE-015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients Attending Consultation for LASIK', 'description': 'Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.', 'interventionNames': ['Other: No Treatment']}], 'interventions': [{'name': 'No Treatment', 'type': 'OTHER', 'description': 'Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.', 'armGroupLabels': ['Patients Attending Consultation for LASIK']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}