Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-27 @ 10:56 AM
Study NCT ID:
NCT01473160
Status:
COMPLETED
Last Update Posted:
2013-04-17
First Post:
2011-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Daily Disposable Contact Lens Tear Film Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'joachim.nick@cibavision.com', 'phone': '+49 6022 240 520', 'title': 'Joachim Nick, Dipl. Ing.', 'organization': 'Alcon Research, Ltd.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Pilot study. Small number of participants analyzed.'}}, 'adverseEventsModule': {'description': 'This reporting group includes all enrolled participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Delefilcon A', 'description': 'Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours', 'otherNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Narafilcon A', 'description': 'Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours', 'otherNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Corrected Visual Acuity of 0.0 or Better', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delefilcon A', 'description': 'Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours'}, {'id': 'OG001', 'title': 'Narafilcon A', 'description': 'Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours'}], 'classes': [{'title': '8 hours after lens insertion', 'categories': [{'measurements': [{'value': '9', 'spread': '0.079', 'groupId': 'OG000'}, {'value': '9', 'spread': '0.089', 'groupId': 'OG001'}]}]}, {'title': '12 hours after lens insertion', 'categories': [{'measurements': [{'value': '9', 'spread': '0.058', 'groupId': 'OG000'}, {'value': '9', 'spread': '0.078', 'groupId': 'OG001'}]}]}, {'title': '16 hours after lens insertion', 'categories': [{'measurements': [{'value': '9', 'spread': '0.079', 'groupId': 'OG000'}, {'value': '9', 'spread': '0.063', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 16 hours after lens insertion', 'description': 'Corrected visual acuity was measured with a digitized logMAR (logarithm of the minimum angle of resolution) chart. A logMAR acuity of 0.0 is considered normal distance eyesight.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants'}, {'type': 'PRIMARY', 'title': 'Pre-Lens Noninvasive Tear Break-Up Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delefilcon A', 'description': 'Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours'}, {'id': 'OG001', 'title': 'Narafilcon A', 'description': 'Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours'}], 'classes': [{'title': '8 hours after lens insertion', 'categories': [{'measurements': [{'value': '12.7', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '11.3', 'spread': '3.5', 'groupId': 'OG001'}]}]}, {'title': '12 hours after lens insertion', 'categories': [{'measurements': [{'value': '12.2', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '13.8', 'spread': '5.4', 'groupId': 'OG001'}]}]}, {'title': '16 hours after lens insertion', 'categories': [{'measurements': [{'value': '10.5', 'spread': '4.5', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '2.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 16 hours after lens insertion', 'description': 'The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a lengthening in the tear film break up time.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants'}, {'type': 'PRIMARY', 'title': 'Average Tear Meniscus Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delefilcon A', 'description': 'Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours'}, {'id': 'OG001', 'title': 'Narafilcon A', 'description': 'Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours'}], 'classes': [{'title': '8 hours after lens insertion', 'categories': [{'measurements': [{'value': '28.0', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '26.7', 'spread': '8.2', 'groupId': 'OG001'}]}]}, {'title': '12 hours after lens insertion', 'categories': [{'measurements': [{'value': '26.0', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '24.0', 'spread': '7.7', 'groupId': 'OG001'}]}]}, {'title': '16 hours after lens insertion', 'categories': [{'measurements': [{'value': '28.7', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '27.1', 'spread': '10.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 16 hours after lens insertion', 'description': 'The tear meniscus height, i.e., the distance between the line of reflection along the top of the tear prism to the edge of the eyelid, was measured by the investigator using a digital slit lamp.', 'unitOfMeasure': 'pixels', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants'}, {'type': 'PRIMARY', 'title': 'Average Ocular Surface Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delefilcon A', 'description': 'Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours'}, {'id': 'OG001', 'title': 'Narafilcon A', 'description': 'Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours'}], 'classes': [{'title': '8 hours after lens insertion', 'categories': [{'measurements': [{'value': '35.6', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '35.3', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': '12 hours after lens insertion', 'categories': [{'measurements': [{'value': '35.2', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '35.2', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': '16 hours after lens insertion', 'categories': [{'measurements': [{'value': '35.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '35.3', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 16 hours after lens insertion', 'description': 'Ocular surface temperature (OST) was recorded by the investigator using a dynamic, non-contact, infrared thermography camera. The average OST (encompassing the wear of a contact lens) was taken at the center of the cornea, at the temporal upper limbal area, and over the central 5 mm2 of the cornea, 2 seconds post-blink.', 'unitOfMeasure': 'Degrees Celsius', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants'}, {'type': 'SECONDARY', 'title': 'Subjective Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delefilcon A', 'description': 'Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours'}, {'id': 'OG001', 'title': 'Narafilcon A', 'description': 'Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours'}], 'classes': [{'title': '8 hours after lens insertion', 'categories': [{'measurements': [{'value': '9.1', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '2.3', 'groupId': 'OG001'}]}]}, {'title': '12 hours after lens insertion', 'categories': [{'measurements': [{'value': '9.0', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': '16 hours after lens insertion', 'categories': [{'measurements': [{'value': '9.1', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 16 hours after lens insertion', 'description': 'Overall comfort was assessed by the participant and recorded on a scale from 0 (poor) to 10 (excellent) in response to the question, "How comfortable is the lens feeling at present?"', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants'}, {'type': 'SECONDARY', 'title': 'Subjective Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delefilcon A', 'description': 'Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours'}, {'id': 'OG001', 'title': 'Narafilcon A', 'description': 'Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours'}], 'classes': [{'title': '8 hours after lens insertion', 'categories': [{'measurements': [{'value': '9.0', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': '12 hours after lens insertion', 'categories': [{'measurements': [{'value': '8.7', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': '16 hours after lens insertion', 'categories': [{'measurements': [{'value': '8.7', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 16 hours after lens insertion', 'description': 'Overall vision was assessed by the participant on scale from 0 (poor) to 10 (excellent) in response to the question, "What is the quality of your vision with the lens at present?"', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adequate Lens Fit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delefilcon A', 'description': 'Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours'}, {'id': 'OG001', 'title': 'Narafilcon A', 'description': 'Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours'}], 'classes': [{'title': '8 hours after lens insertion', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': '12 hours after lens insertion', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': '16 hours after lens insertion', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 16 hours after lens insertion', 'description': 'Lens fit was assessed by the investigator with a biomicroscope (slit lamp).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Overall Study', 'description': 'All enrolled participants'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from one study center in the UK.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study', 'description': 'All enrolled participants'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31', 'spread': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-16', 'studyFirstSubmitDate': '2011-11-14', 'resultsFirstSubmitDate': '2012-11-19', 'studyFirstSubmitQcDate': '2011-11-14', 'lastUpdatePostDateStruct': {'date': '2013-04-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-01-14', 'studyFirstPostDateStruct': {'date': '2011-11-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Corrected Visual Acuity of 0.0 or Better', 'timeFrame': 'Up to 16 hours after lens insertion', 'description': 'Corrected visual acuity was measured with a digitized logMAR (logarithm of the minimum angle of resolution) chart. A logMAR acuity of 0.0 is considered normal distance eyesight.'}, {'measure': 'Pre-Lens Noninvasive Tear Break-Up Time', 'timeFrame': 'Up to 16 hours after lens insertion', 'description': 'The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a lengthening in the tear film break up time.'}, {'measure': 'Average Tear Meniscus Height', 'timeFrame': 'Up to 16 hours after lens insertion', 'description': 'The tear meniscus height, i.e., the distance between the line of reflection along the top of the tear prism to the edge of the eyelid, was measured by the investigator using a digital slit lamp.'}, {'measure': 'Average Ocular Surface Temperature', 'timeFrame': 'Up to 16 hours after lens insertion', 'description': 'Ocular surface temperature (OST) was recorded by the investigator using a dynamic, non-contact, infrared thermography camera. The average OST (encompassing the wear of a contact lens) was taken at the center of the cornea, at the temporal upper limbal area, and over the central 5 mm2 of the cornea, 2 seconds post-blink.'}], 'secondaryOutcomes': [{'measure': 'Subjective Comfort', 'timeFrame': 'Up to 16 hours after lens insertion', 'description': 'Overall comfort was assessed by the participant and recorded on a scale from 0 (poor) to 10 (excellent) in response to the question, "How comfortable is the lens feeling at present?"'}, {'measure': 'Subjective Vision', 'timeFrame': 'Up to 16 hours after lens insertion', 'description': 'Overall vision was assessed by the participant on scale from 0 (poor) to 10 (excellent) in response to the question, "What is the quality of your vision with the lens at present?"'}, {'measure': 'Number of Participants With Adequate Lens Fit', 'timeFrame': 'Up to 16 hours after lens insertion', 'description': 'Lens fit was assessed by the investigator with a biomicroscope (slit lamp).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the pre-lens tear film stability of a new CE-marked daily disposable contact lens as compared to a commercially available daily disposable contact lens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be of legal age of consent and sign Informed Consent document.\n* Willing and able to wear spherical contact lenses for 16 hours.\n* Willing and able to wear spherical contact lenses within the available range of powers.\n* Best corrected spectacle visual acuity equal or better than 20/25 or 6/7.5.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Anterior segment infection, inflammation, or abnormality.\n* Any use of systemic medications for which contact lens wear could be contraindicated.\n* History of refractive surgery or irregular cornea.\n* Currently enrolled in any clinical trial.\n* Eye injury within twelve weeks prior to enrollment.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01473160', 'briefTitle': 'Daily Disposable Contact Lens Tear Film Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'DAILIES TOTAL1 Pre-Lens Tear Film Performance - Pilot Trial', 'orgStudyIdInfo': {'id': 'P-347-C-014v2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'delefilcon A', 'description': 'Delefilcon A randomly assigned to one eye, with narafilcon A assigned to the fellow eye for contralateral wear. Both products will be worn for one day for 16 hours (+/- 1 hour).', 'interventionNames': ['Device: delefilcon A contact lens']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'narafilcon A', 'description': 'Narafilcon A randomly assigned to one eye, with delefilcon A assigned to the fellow eye for contralateral wear. Both products will be worn for one day for 16 hours (+/- 1 hour).', 'interventionNames': ['Device: narafilcon A contact lens']}], 'interventions': [{'name': 'delefilcon A contact lens', 'type': 'DEVICE', 'otherNames': ['DAILIES TOTAL1'], 'description': 'CE-marked, silicone hydrogel, single vision, soft contact lens for daily disposable wear', 'armGroupLabels': ['delefilcon A']}, {'name': 'narafilcon A contact lens', 'type': 'DEVICE', 'otherNames': ['1-DAY ACUVUE TruEye'], 'description': 'Commercially marketed, silicone hydrogel, single vision, soft contact lens for daily disposable wear.', 'armGroupLabels': ['narafilcon A']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B4 7ET', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Aston University', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CIBA VISION', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Aston University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}