Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2026-03-01 @ 1:44 PM
Study NCT ID:
NCT02872194
Status:
COMPLETED
Last Update Posted:
2018-12-12
First Post:
2016-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Stinging Potential of Products in Human Eyes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2014-09-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-11', 'studyFirstSubmitDate': '2016-08-03', 'studyFirstSubmitQcDate': '2016-08-17', 'lastUpdatePostDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective discomfort in the eye was assessed based on questions by an Ophthalmologist to the subject using a 5-category intensity scale', 'timeFrame': 'up to 24 hours after instillation'}, {'measure': 'Tearing/Lacrimation was assessed by the Ophthalmologist using a 5-category assessment score', 'timeFrame': 'up to 24 hours after instillation'}, {'measure': 'Objective inflammation was assessed by the Ophthalmologist using a 5-category assessment score', 'timeFrame': 'up to 24 hours after instillation'}, {'measure': 'Post installation eye effects were assessed using a 5-category intensity score', 'timeFrame': 'up to 24 hours after instillation'}], 'secondaryOutcomes': [{'measure': 'Number of adverse events as a measure of safety and tolerability', 'timeFrame': 'at 24 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sunscreen Agents']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_BSP_7261&studyid=2860&filename=17913_Study%20Synopsis_CTP.pdf', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study was to compare the human eye stinging potential of experimental formulas and an industry standard shampoo mixture. The study was conducted under the supervision of a Board Certified Ophthalmologist. The study design was a three cell, single blind study. Subjects were given the industry standard shampoo mixture in one eye and an exploratory sunscreen in the other as according to the randomization schedule.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female subjects, aged 18 to 65 years\n* No medical conditions of the eyes as determined by the subjects' medical history and confirmed by ophthalmologist\n* Subjects do not wear contact lenses or, if he/she does wear contact lenses, is willing to refrain from wearing these during the day of and day after the study\n* Subject is willing to have the test materials instilled into the eyes and follow all protocol requirements\n* Subject is willing to refrain from using false eyelashes of any type or any topical prescription, OTC or cosmetic products on their eyes, eyelids, eyelashes or the peri-orbital areas of the face on the day of the study.\n* Subjects should refrain from use of make-up on testing day"}, 'identificationModule': {'nctId': 'NCT02872194', 'briefTitle': 'Evaluation of the Stinging Potential of Products in Human Eyes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Evaluation of the Stinging Potential of Products in Human Eyes', 'orgStudyIdInfo': {'id': '17913'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Suncare agent A + control', 'description': 'Application of control and test product into one of the subjects two eyes.', 'interventionNames': ['Drug: BAY987516, Y55-170', 'Drug: Standard shampoo mixture (control)']}, {'type': 'EXPERIMENTAL', 'label': 'Suncare agent B + control', 'description': 'Application of control and test product into one of the subjects two eyes.', 'interventionNames': ['Drug: BAY987516, X72-151', 'Drug: Standard shampoo mixture (control)']}, {'type': 'EXPERIMENTAL', 'label': 'Suncare agent C + control', 'description': 'Application of control and test product into one of the subjects two eyes.', 'interventionNames': ['Drug: BAY987516, Y49-034', 'Drug: Standard shampoo mixture (control)']}], 'interventions': [{'name': 'BAY987516, Y55-170', 'type': 'DRUG', 'description': '10 uL in one eye', 'armGroupLabels': ['Suncare agent A + control']}, {'name': 'BAY987516, X72-151', 'type': 'DRUG', 'description': '10 uL in one eye', 'armGroupLabels': ['Suncare agent B + control']}, {'name': 'BAY987516, Y49-034', 'type': 'DRUG', 'description': '10 uL in one eye', 'armGroupLabels': ['Suncare agent C + control']}, {'name': 'Standard shampoo mixture (control)', 'type': 'DRUG', 'description': '10 uL in one eye', 'armGroupLabels': ['Suncare agent A + control', 'Suncare agent B + control', 'Suncare agent C + control']}]}, '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'}}}}