Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2026-03-02 @ 6:24 PM
Study NCT ID:
NCT02055404
Status:
COMPLETED
Last Update Posted:
2014-04-02
First Post:
2014-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
On-Eye Evaluation of Contact Lens Rotation Marks
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'Joachim Nick, Dipl. Ing.', 'organization': 'Alcon Research, Ltd.'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for the duration of the study (1 day).', 'description': 'The analysis population includes includes all enrolled participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Delefilcon A', 'description': 'Delefilcon A spherical contact lens with molded marks randomly assigned to one eye, with etafilcon A toric contact lens in the fellow eye for contralateral wear approximately 2 hours in duration.', 'otherNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Etafilcon A', 'description': 'Etafilcon A toric contact lens randomly assigned to one eye, with delefilcon A spherical contact lens with molded marks in the fellow eye for contralateral wear approximately 2 hours in duration', 'otherNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Visibility of Rotation Mark (Clearly Visible, Slightly Visible Acceptable)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'S1 Mark', 'description': 'Delefilcon A spherical contact lens with 1 of 9 molded marks'}, {'id': 'OG001', 'title': 'S2 Mark', 'description': 'Delefilcon A spherical contact lens with 1 of 9 molded marks'}, {'id': 'OG002', 'title': 'S3 Mark', 'description': 'Delefilcon A spherical contact lens with 1 of 9 molded marks'}, {'id': 'OG003', 'title': 'S4 Mark', 'description': 'Delefilcon A spherical contact lens with 1 of 9 molded marks'}, {'id': 'OG004', 'title': 'S5 Mark', 'description': 'Delefilcon A spherical contact lens with 1 of 9 molded marks'}, {'id': 'OG005', 'title': 'S6 Mark', 'description': 'Delefilcon A spherical contact lens with 1 of 9 molded marks'}, {'id': 'OG006', 'title': 'S7 Mark', 'description': 'Delefilcon A spherical contact lens with 1 of 9 molded marks'}, {'id': 'OG007', 'title': 'S8 Mark', 'description': 'Delefilcon A spherical contact lens with 1 of 9 molded marks'}, {'id': 'OG008', 'title': 'Control', 'description': 'Etafilcon A toric contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000'}, {'value': '71.4', 'groupId': 'OG001'}, {'value': '78.6', 'groupId': 'OG002'}, {'value': '46.4', 'groupId': 'OG003'}, {'value': '71.4', 'groupId': 'OG004'}, {'value': '82.1', 'groupId': 'OG005'}, {'value': '78.6', 'groupId': 'OG006'}, {'value': '75.0', 'groupId': 'OG007'}, {'value': '93.3', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Each lens (containing 8 rotation marks and one reference mark, in total 9 marks) was assessed for visibility by 10 investigators using the following scale: "N/A;" "Not visible;" "Slightly visible, not acceptable;" "Slightly visible, acceptable;" "Clearly visible;" "More visible than necessary." Visibility assessments were made after all marks had been evaluated. S9 Mark (test lens) functioned as a starting marker only and was not rated. The control lens was not used as a comparison, but rather as a reference for what a mark looks like on a commercial product. "Visibility of Rotation Mark" is reported as the percentage of assessments rating the rotation mark as "Clearly visible" or "Slightly visible, acceptable."', 'unitOfMeasure': 'Percentage of assessments', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all enrolled participants. Assessments from all 10 investigators were analyzed, hence sample size for each rotational mark is 30.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Overall Study', 'description': 'Delefilcon A spherical contact lens with molded marks and etafilcon A toric contact lens worn contralaterally (1 in each eye) for approximately 2 hours'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from 1 US study center.', 'preAssignmentDetails': 'This reporting group includes all enrolled participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study', 'description': 'Delefilcon A spherical contact lens with molded marks and etafilcon A toric contact lens worn contralaterally (1 in each eye) for approximately 2 hours'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.0', 'spread': '21.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The analysis population includes all enrolled participants.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-20', 'studyFirstSubmitDate': '2014-02-04', 'resultsFirstSubmitDate': '2014-02-20', 'studyFirstSubmitQcDate': '2014-02-04', 'lastUpdatePostDateStruct': {'date': '2014-04-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-02-20', 'studyFirstPostDateStruct': {'date': '2014-02-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visibility of Rotation Mark (Clearly Visible, Slightly Visible Acceptable)', 'timeFrame': 'Day 1', 'description': 'Each lens (containing 8 rotation marks and one reference mark, in total 9 marks) was assessed for visibility by 10 investigators using the following scale: "N/A;" "Not visible;" "Slightly visible, not acceptable;" "Slightly visible, acceptable;" "Clearly visible;" "More visible than necessary." Visibility assessments were made after all marks had been evaluated. S9 Mark (test lens) functioned as a starting marker only and was not rated. The control lens was not used as a comparison, but rather as a reference for what a mark looks like on a commercial product. "Visibility of Rotation Mark" is reported as the percentage of assessments rating the rotation mark as "Clearly visible" or "Slightly visible, acceptable."'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['astigmatism', 'toric', 'contact lenses', 'daily disposable contact lenses', 'molded mark', 'rotation mark'], 'conditions': ['Refractive Error']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to select the size of the molded rotation mark for a new toric contact lens by comparing the visibility of various molded rotation marks.', 'detailedDescription': 'Participants wore the test and control products contralaterally (in each eye separately) for 2 hours, during which the Investigator assessed the various molded rotation marks for visibility. Each participant was assessed by 10 investigators.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sign Informed Consent document.\n* Best corrected distance visual acuity (VA) greater than or equal to 20/25 in each eye.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* History of any ocular surgery or ocular injury within 12 weeks of study enrollment.\n* Any ocular disease, infection, inflammation, or abnormality that contraindicates contact lens (CL) wear.\n* History of herpetic keratitis.\n* Slit-lamp findings greater than grade 2 at baseline.\n* Any use of systemic or ocular medications for which CL wear could be contraindicated.\n* Inactive corneal neovascularization greater than 1 millimeter of penetration.\n* A clinically significant dry eye not responding to treatment.\n* History of refractive surgery.\n* Participation in a clinical study within the previous 30 days.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02055404', 'briefTitle': 'On-Eye Evaluation of Contact Lens Rotation Marks', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'orgStudyIdInfo': {'id': 'C-12-045'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Delefilcon A', 'description': 'Delefilcon A spherical contact lens with molded marks randomly assigned to one eye, with etafilcon A toric contact lens in the fellow eye for contralateral wear approximately 2 hours in duration', 'interventionNames': ['Device: Delefilcon A spherical contact lens with molded marks']}, {'type': 'OTHER', 'label': 'Etafilcon A', 'description': 'Etafilcon A toric contact lens randomly assigned to one eye, with delefilcon A spherical contact lens with molded marks in the fellow eye for contralateral wear approximately 2 hours in duration', 'interventionNames': ['Device: Etafilcon A toric contact lens']}], 'interventions': [{'name': 'Delefilcon A spherical contact lens with molded marks', 'type': 'DEVICE', 'description': 'Silicone hydrogel contact lens with 9 different molded marks of varying widths and depths indented into the front surface (S1, S2, S3, S4, S5, S6, S7, S8, and S9). Each lens contained all 9 marks.', 'armGroupLabels': ['Delefilcon A']}, {'name': 'Etafilcon A toric contact lens', 'type': 'DEVICE', 'otherNames': ['1-DAY ACUVUE® MOIST® for ASTIGMATISM'], 'description': 'Hydrogel toric contact lens for daily wear, daily disposable use', 'armGroupLabels': ['Etafilcon A']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Joachim Nick, Dipl. Ing.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}