Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-27 @ 10:51 PM
Study NCT ID:
NCT05573360
Status:
COMPLETED
Last Update Posted:
2023-07-06
First Post:
2022-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Safety and Tolerability of Ocular Lubricants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-03', 'studyFirstSubmitDate': '2022-10-04', 'studyFirstSubmitQcDate': '2022-10-06', 'lastUpdatePostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Treatment-Emergent Adverse Events (AEs)', 'timeFrame': 'Up to Day 30 (Study Exit)', 'description': 'An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device (test product). The number of adverse events as observed or reported will be recorded.'}, {'measure': 'Number of Subjects with Biomicroscopy Findings Outside of Normal Limits', 'timeFrame': 'Screening, up to Day 30 (Study Exit)', 'description': 'The cornea, conjunctiva, and eyelid will be assessed using a slit lamp. The number of subjects with biomicroscopy findings outside of normal limits will be recorded.'}, {'measure': 'Mean Total Ocular Surface Staining Score', 'timeFrame': 'Screening, up to Day 30 (Study Exit)', 'description': 'Ocular surface staining will be assessed using a slit lamp and recorded on a 15-point scale.'}, {'measure': 'Mean Best Corrected Visual Acuity (BCVA)', 'timeFrame': 'Screening, up to Day 30 (Study Exit)', 'description': 'Visual Acuity will be assessed with correction in place using letter charts. BCVA will be measured in logarithm Minimum Angle of Resolution (logMAR).'}, {'measure': 'Number of Device Deficiencies', 'timeFrame': 'Up to Day 30 (Study Exit)', 'description': 'A device deficiency is inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety, or performance. The number of device deficiencies as observed or reported will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety profile of test formulations for an artificial tear product versus a comparator product.', 'detailedDescription': 'Subjects will be randomized to one of five different treatment sequences. Subjects will attend 6 scheduled visits with an expected individual duration of participation of 11 to 42 days. This study will be conducted in 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 informed consent form.\n* Willing and able to attend all study visits as required by the protocol.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Any known active ocular disease.\n* Any systemic condition that, in the opinion of the investigator, may affect a study outcome variable.\n* Any ocular injury to either eye in the past 12 weeks prior to screening.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT05573360', 'briefTitle': 'Evaluation of Safety and Tolerability of Ocular Lubricants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Evaluation of Safety and Tolerability of Ocular Lubricants', 'orgStudyIdInfo': {'id': 'DEE253-E001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Sequence 1', 'description': 'NGF5-A/NGF4-B/NGF6-B/NGF6-E/Systane, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation', 'interventionNames': ['Other: NGF5-A test formulation', 'Other: NGF4-B test formulation', 'Other: NGF6-B test formulation', 'Other: NGF6-E test formulation', 'Other: Systane eye drop']}, {'type': 'OTHER', 'label': 'Sequence 2', 'description': 'NGF4-B/NGF6-B/NGF6-E/Systane/NGF5-A, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation', 'interventionNames': ['Other: NGF5-A test formulation', 'Other: NGF4-B test formulation', 'Other: NGF6-B test formulation', 'Other: NGF6-E test formulation', 'Other: Systane eye drop']}, {'type': 'OTHER', 'label': 'Sequence 3', 'description': 'NGF6-B/NGF6-E/Systane/NGF5-A/NGF4-B, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation', 'interventionNames': ['Other: NGF5-A test formulation', 'Other: NGF4-B test formulation', 'Other: NGF6-B test formulation', 'Other: NGF6-E test formulation', 'Other: Systane eye drop']}, {'type': 'OTHER', 'label': 'Sequence 4', 'description': 'NGF6-E/Systane/NGF5-A/NGF4-B/NGF6-B, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation', 'interventionNames': ['Other: NGF5-A test formulation', 'Other: NGF4-B test formulation', 'Other: NGF6-B test formulation', 'Other: NGF6-E test formulation', 'Other: Systane eye drop']}, {'type': 'OTHER', 'label': 'Sequence 5', 'description': 'Systane/NGF5-A/NGF4-B/NGF6-B/NGF6-E, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation', 'interventionNames': ['Other: NGF5-A test formulation', 'Other: NGF4-B test formulation', 'Other: NGF6-B test formulation', 'Other: NGF6-E test formulation', 'Other: Systane eye drop']}], 'interventions': [{'name': 'NGF5-A test formulation', 'type': 'OTHER', 'description': 'One drop of investigational product instilled on the eye', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4', 'Sequence 5']}, {'name': 'NGF4-B test formulation', 'type': 'OTHER', 'description': 'One drop of investigational product instilled on the eye', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4', 'Sequence 5']}, {'name': 'NGF6-B test formulation', 'type': 'OTHER', 'description': 'One drop of investigational product instilled on the eye', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4', 'Sequence 5']}, {'name': 'NGF6-E test formulation', 'type': 'OTHER', 'description': 'One drop of investigational product instilled on the eye', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4', 'Sequence 5']}, {'name': 'Systane eye drop', 'type': 'OTHER', 'description': 'One drop of commercial product instilled on the eye', '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}}, {'zip': '3216', 'city': 'Waurn Ponds', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Alcon Investigator 8214', 'geoPoint': {'lat': -38.21667, 'lon': 144.28333}}], 'overallOfficials': [{'name': 'Clinical Trial Lead, Dry Eye', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}