Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-01 @ 11:09 AM
Study NCT ID:
NCT00938951
Status:
COMPLETED
Last Update Posted:
2012-02-09
First Post:
2009-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Ability of Systane Ultra to Improve Subjective Symptoms of Ocular Irritation Post 60 Min. Athletic Performance.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'lastUpdateSubmitDate': '2012-02-08', 'studyFirstSubmitDate': '2009-07-13', 'studyFirstSubmitQcDate': '2009-07-13', 'lastUpdatePostDateStruct': {'date': '2012-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Effectiveness of eye drop basd on athlete's opinion/experience during a one hour practice session", 'timeFrame': '60 minutes post-dosing with test article'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dry Eye', 'Visual Performance'], 'conditions': ['Dry Eye Symptoms', 'Visual Performance']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to compare visual degradation in a stressed (forced stare) environment in patients before and after acute administration of Systane Ultra.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Player/ Coach must answer "Yes" to the survey eligibility question.\n* Player/Coach must voluntarily agree to participate in survey\n\nExclusion Criteria:\n\n* None.'}, 'identificationModule': {'nctId': 'NCT00938951', 'briefTitle': 'Evaluate the Ability of Systane Ultra to Improve Subjective Symptoms of Ocular Irritation Post 60 Min. Athletic Performance.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'orgStudyIdInfo': {'id': 'SMA-09-22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Systane® Ultra', 'description': 'Systane® Ultra', 'interventionNames': ['Other: Systane® Ultra']}], 'interventions': [{'name': 'Systane® Ultra', 'type': 'OTHER', 'description': 'Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%', 'armGroupLabels': ['Systane® Ultra']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}