Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2026-02-22 @ 3:55 PM
Study NCT ID:
NCT02714166
Status:
COMPLETED
Last Update Posted:
2017-03-30
First Post:
2016-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Irritation Potential of Products in Human Eyes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059405', 'term': 'Sun Protection Factor'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011874', 'term': 'Radiometry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-29', 'studyFirstSubmitDate': '2016-03-04', 'studyFirstSubmitQcDate': '2016-03-16', 'lastUpdatePostDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective assessment of discomfort in the eyes assessed by 5 point scale.', 'timeFrame': 'Up to 1 day'}, {'measure': 'Intensity of Lacrimation assessed by 5 grading scale.', 'timeFrame': 'Up to 1 day'}, {'measure': 'Intensity of Bulbar Conjunctiva Irritation assessed by 4 grading scale.', 'timeFrame': 'Up to 1 day'}, {'measure': 'Intensity of Palpebral Conjunctiva Irritation assessed by 4 grading scale.', 'timeFrame': 'Up to 1 day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sunscreening Agents']}, 'descriptionModule': {'briefSummary': 'To evaluate the human eye irritation potential of one test sunscreen formulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be healthy males or females between the ages of 18 to 60 years inclusive with no medical conditions of the eyes.\n* Do not wear contact lenses or, if he/she does wear contact lenses, is willing to refrain from wearing these during the test period.\n* Willing to report any medications taken during the study.\n* Willing to have the test materials instilled into the eyes and follow all protocol requirements.\n* Have been informed and have given written consent to participate in the study.\n\nExclusion Criteria:\n\n* Has ocular disease or peri-orbital dermatitis or trauma, infections or chronic eye conditions that may affect the study outcome.\n* Has systemic illness which affects the eyes, including diabetes, thyroid disease, sarcoidosis, hypertension, atherosclerosis, lupus, multiple sclerosis, sickle cell disease, AIDs (Acquired Immune Deficiency Syndrome), severer rheumatoid arthritis. results as determined by the investigator.\n* Must not have a history of pre-existing sensitivity or other types of allergy to any eye products.\n* Must not have received and used an Investigational New Drug within the thirty days immediately preceding the study.'}, 'identificationModule': {'nctId': 'NCT02714166', 'briefTitle': 'Evaluation of the Irritation Potential of Products in Human Eyes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Evaluation of the Irritation Potential of Products in Human Eyes', 'orgStudyIdInfo': {'id': '18766'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sunscreen lotion Sun Protection Factor 50 (BAY987521)', 'description': 'Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.', 'interventionNames': ['Other: Sunscreen lotion SPF (Sun Protection Factor) 50 (BAY987521)']}, {'type': 'OTHER', 'label': 'Ophthalmic Ointment', 'description': 'Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.', 'interventionNames': ['Other: Ophthalmic Ointment']}], 'interventions': [{'name': 'Sunscreen lotion SPF (Sun Protection Factor) 50 (BAY987521)', 'type': 'OTHER', 'description': 'Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.', 'armGroupLabels': ['Sunscreen lotion Sun Protection Factor 50 (BAY987521)']}, {'name': 'Ophthalmic Ointment', 'type': 'OTHER', 'description': 'Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.', 'armGroupLabels': ['Ophthalmic Ointment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33714', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}