Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-10 @ 11:48 PM
Study NCT ID:
NCT04830956
Status:
COMPLETED
Last Update Posted:
2021-11-16
First Post:
2021-04-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Comfort in Subjects With Moderate Dry Eye Disease
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': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-15', 'studyFirstSubmitDate': '2021-04-01', 'studyFirstSubmitQcDate': '2021-04-01', 'lastUpdatePostDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in comfort rating', 'timeFrame': 'Baseline, up to 12 Hours (Day 1, each product)', 'description': 'A visual analogue scale will be used'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dry eye'], 'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the comfort of an ocular lubricant in dry eye subjects. This study will be conducted in Canada and Australia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Able to understand and sign an information consent letter\n* Willing and able to follow instructions and maintain the appointment schedule\n* Has dry eye symptoms\n\nKey Exclusion Criteria:\n\n* Has suffered any ocular injury to either eye in the past 12 weeks\n* Is pregnant or lactating at the time of enrollment\n\nOther protocol-specified inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT04830956', 'briefTitle': 'Evaluation of Comfort in Subjects With Moderate Dry Eye Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Evaluation of Comfort in Subjects With Moderate Dry Eye Disease', 'orgStudyIdInfo': {'id': 'DEJ475-E004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence 1', 'description': 'FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product.', 'interventionNames': ['Other: FID123238', 'Other: Systane Hydration']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 2', 'description': 'FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product.', 'interventionNames': ['Other: FID123238', 'Other: Systane Hydration']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 3', 'description': 'FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product.', 'interventionNames': ['Other: FID123238', 'Other: Systane Hydration']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 4', 'description': 'FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product.', 'interventionNames': ['Other: FID123238', 'Other: Systane Hydration']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 5', 'description': 'FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product.', 'interventionNames': ['Other: FID123238', 'Other: Systane Hydration']}], 'interventions': [{'name': 'FID123238', 'type': 'OTHER', 'description': 'Lubricant applied to the ocular surface', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4', 'Sequence 5']}, {'name': 'Systane Hydration', 'type': 'OTHER', 'description': 'Drops applied to the ocular surface', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4', 'Sequence 5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3053', 'city': 'Carlton', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Alcon Investigator 8169', 'geoPoint': {'lat': -37.8, 'lon': 144.96667}}], 'overallOfficials': [{'name': 'Clinical Trial Lead, Dry Eye', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}