Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2026-01-22 @ 12:20 PM
Study NCT ID:
NCT00983203
Status:
COMPLETED
Last Update Posted:
2012-02-02
First Post:
2009-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Comfort and Haze Profile of FID 114657
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'lastUpdateSubmitDate': '2012-01-31', 'studyFirstSubmitDate': '2009-09-23', 'studyFirstSubmitQcDate': '2009-09-23', 'lastUpdatePostDateStruct': {'date': '2012-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Drop comfort upon instillation', 'timeFrame': 'Upon instillation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dry eye', 'artificial tears'], 'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to describe the acute comfort and haze profile of FID 114657 in dry eye patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented diagnosis of dry eye\n\nExclusion Criteria:\n\n* Must not have worn contact lenses for 1 week preceding enrollment'}, 'identificationModule': {'nctId': 'NCT00983203', 'briefTitle': 'Acute Comfort and Haze Profile of FID 114657', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'orgStudyIdInfo': {'id': 'C-09-014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FID 114657', 'description': 'FID 114657', 'interventionNames': ['Other: FID 114657 ORB Preserved Ocular Emulsion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Soothe XP Lubricant Eye Drops', 'description': 'Soothe XP Lubricant Eye Drops', 'interventionNames': ['Other: Soothe XP Lubricant Eye Drops']}], 'interventions': [{'name': 'FID 114657 ORB Preserved Ocular Emulsion', 'type': 'OTHER', 'description': '1 drop OU', 'armGroupLabels': ['FID 114657']}, {'name': 'Soothe XP Lubricant Eye Drops', 'type': 'OTHER', 'description': '1 drop OU', 'armGroupLabels': ['Soothe XP Lubricant Eye Drops']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}