Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-28 @ 8:48 PM
Study NCT ID:
NCT01051804
Status:
COMPLETED
Last Update Posted:
2012-02-02
First Post:
2010-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Repeated Usage of Systane Ultra Eyedrop
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'lastUpdateSubmitDate': '2012-01-31', 'studyFirstSubmitDate': '2010-01-18', 'studyFirstSubmitQcDate': '2010-01-19', 'lastUpdatePostDateStruct': {'date': '2012-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in objective vision', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Measurement of tear film evaporation', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dry eye', 'Visual Performance'], 'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': 'Comparison of two contact lens solutions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or more.\n* Non contact lens wearer.\n* Symptomatology as defined below for the Ocular Surface Disease Index (OSDI) questionnaire:\n\n * Score ≥13 for OSDI Questionnaire total score; AND\n * Scores of at least 2 for 2 out of the 6 vision related questions of the OSDI questionnaire\n* Best visual acuity of 6/9 or better in each eye.\n* Willingness to adhere to the instructions set in the clinical protocol.\n* Signature of the subject informed consent form.\n\nExclusion Criteria:\n\n* Use of systemic medication which might produce dry eye side effects.\n* Systemic disease which might produce dry eye side effects.\n* Active ocular infection.\n* Use of ocular medication.\n* Significant ocular anomaly.\n* Previous ocular surgery\n* Previous use of Restasis\n* Any medical condition that might be prejudicial to the study.\n* The subject, based on their knowledge, must NOT be pregnant or lactating at the time of enrolment.\n* The subject, based on his/her knowledge, must NOT have an infectious disease (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. Human Immunodeficiency Virus).\n* The subject, based on their knowledge, must NOT have diabetes.'}, 'identificationModule': {'nctId': 'NCT01051804', 'briefTitle': 'Evaluation of the Repeated Usage of Systane Ultra Eyedrop', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'orgStudyIdInfo': {'id': 'SMA-09-33'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Systane Ultra', 'description': 'Systane Ultra Lubricant Eye Drops', 'interventionNames': ['Other: Systane Ultra']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Optive', 'description': 'Optive Lubricant Eye Drops', 'interventionNames': ['Other: Optive lubricant Eye Drops']}], 'interventions': [{'name': 'Systane Ultra', 'type': 'OTHER', 'description': 'Systane Ultra 1 to 2 drops per eye at least 4 times daily for 4 weeks', 'armGroupLabels': ['Systane Ultra']}, {'name': 'Optive lubricant Eye Drops', 'type': 'OTHER', 'description': 'Optive Lubricant Eye Drops 1 to 2 drops per eye at least 4 times daily for 4 weeks', 'armGroupLabels': ['Optive']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}