Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2026-02-28 @ 11:21 AM
Study NCT ID:
NCT03253393
Status:
COMPLETED
Last Update Posted:
2021-12-03
First Post:
2017-08-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Smart Touch Non-dispensing Handling Studies
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jacqueline.tan@unsw.edu.au', 'phone': '+612 9385 6551', 'title': 'Dr Jacqueline Tan', 'organization': 'University of New South Wales'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Participants were monitored for adverse events occurring during lens wear i.e. 45 minutes for each visit, up to 3 visits.', 'description': 'Participants were monitored for adverse events at each visit', 'eventGroups': [{'id': 'EG000', 'title': 'Silicone Hydrogel (With EDTA) in Smart Touch', 'description': 'Lens Contamination for Silicone Hydrogel lenses in Smart Touch™ (with EDTA).', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Silicone Hydrogel (With EDTA) in Conventional Packaging', 'description': 'Lens Contamination for Silicone hydrogel (with EDTA) in conventional packaging', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Silicone Hydrogel (no EDTA) in Smart Touch', 'description': 'Lens Contamination for Silicone Hydrogel lenses in Smart Touch™ (no EDTA).', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Hydrogel (no EDTA) in Smart Touch', 'description': 'Lens Contamination for Hydrogel lenses in Smart Touch™ (no EDTA).', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Hydrogel (no EDTA) in Conventional Packaging', 'description': 'Lens Contamination for Hydrogel in Conventional packaging (no EDTA).', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Hydrogel (With EDTA) in Smart Touch', 'description': 'Lens Contamination for Hydrogel lenses in Smart Touch™ (with EDTA).', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Without Contamination of Contact Lenses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Silicone Hydrogel (With EDTA) in Smart Touch', 'description': 'Lens Contamination for Silicone Hydrogel lenses in Smart Touch™ (with EDTA).'}, {'id': 'OG001', 'title': 'Silicone Hydrogel (With EDTA) in Conventional Packaging', 'description': 'Lens Contamination for Silicone hydrogel (with EDTA) in conventional packaging'}, {'id': 'OG002', 'title': 'Silicone Hydrogel (no EDTA) in Smart Touch', 'description': 'Lens Contamination for Silicone Hydrogel lenses in Smart Touch™ (no EDTA).'}, {'id': 'OG003', 'title': 'Hydrogel (no EDTA) in Smart Touch', 'description': 'Lens Contamination for Hydrogel lenses in Smart Touch™ (no EDTA).'}, {'id': 'OG004', 'title': 'Hydrogel (no EDTA) in Conventional Packaging', 'description': 'Lens Contamination for Hydrogel in Conventional packaging (no EDTA).'}, {'id': 'OG005', 'title': 'Hydrogel (With EDTA) in Smart Touch', 'description': 'Lens Contamination for Hydrogel lenses in Smart Touch™ (with EDTA).'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After 45 minutes of lens wear', 'description': 'Number of Participants Without Contamination of Contact Lenses after 45 minutes of wear', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bacterial Counts of Worn Contact Lenses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}]}, {'units': 'Lens', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Silicone Hydrogel (With EDTA) in Smart Touch', 'description': 'Lens Contamination for Silicone Hydrogel lenses in Smart Touch™ (with EDTA).'}, {'id': 'OG001', 'title': 'Silicone Hydrogel (With EDTA) in Conventional Packaging', 'description': 'Lens Contamination for Silicone hydrogel (with EDTA) in conventional packaging'}, {'id': 'OG002', 'title': 'Silicone Hydrogel (no EDTA) in Smart Touch', 'description': 'Lens Contamination for Silicone Hydrogel lenses in Smart Touch™ (no EDTA).'}, {'id': 'OG003', 'title': 'Hydrogel (no EDTA) in Smart Touch', 'description': 'Lens Contamination for Hydrogel lenses in Smart Touch™ (no EDTA).'}, {'id': 'OG004', 'title': 'Hydrogel (no EDTA) in Conventional Packaging', 'description': 'Lens Contamination for Hydrogel in Conventional packaging (no EDTA).'}, {'id': 'OG005', 'title': 'Hydrogel (With EDTA) in Smart Touch', 'description': 'Lens Contamination for Hydrogel lenses in Smart Touch™ (with EDTA).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '43'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '25'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '17'}, {'value': '1', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '16'}, {'value': '0', 'groupId': 'OG005', 'lowerLimit': '0', 'upperLimit': '9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'After 45 minutes of lens wear', 'description': 'Bacterial counts of contact lenses after 45 minutes of wear (CFU count /lens)', 'unitOfMeasure': 'CFU count per lens', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lens', 'denomUnitsSelected': 'Lens'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SiH (With EDTA) , Then H (no EDTA), Then SiH (Without EDTA) and H (With EDTA) in Smart Touch', 'description': 'Participants first received a Silicone Hydrogel lens (with EDTA) in Smart Touch packaging which was inserted in one eye and a Silicone Hydrogel lens (with EDTA) in a conventional blister which was inserted in the other eye. After a minimum washout period of 48 hours, they then received a Hydrogel lens (no EDTA) in Smart Touch packaging which was inserted in one eye and a Hydrogel lens in a conventional blister which was inserted in the other eye. After a minimum washout period of 48 hours they then received a Silicone Hydrogel lens (without EDTA) in Smart Touch packaging in one eye and a Hydrogel lens (with EDTA) in Smart Touch packaging in the other eye.\n\nSmart Touch Technology packaging: midafilcon A contact lens in Smart Touch Technology Flat Pack (silicone hydrogel, with EDTA)\n\nConventional lens packaging: hioxifilcon A contact lens in conventional lens packaging (hydrogel, no EDTA) asmofilcon A contact lens in conventional lens packaging (silicone hydrogel, with EDTA)'}, {'id': 'FG001', 'title': 'H (no EDTA), Then SiH (With EDTA), Then SiH (Without EDTA) vs H (With EDTA) in Smart Touch', 'description': 'Participants first received a Hydrogel lens (no EDTA) in Smart Touch packaging which was inserted in one eye and a Hydrogel lens in a conventional blister which was inserted in the other eye. After a minimum washout period of 48 hours, they then received a Silicone Hydrogel lens (with EDTA) in Smart Touch packaging which was inserted in one eye and a Silicone Hydrogel lens (with EDTA) in a conventional blister which was inserted in the other eye. After a minimum washout period of 48 hours they then received a Silicone Hydrogel lens (without EDTA) in Smart Touch packaging in one eye and a Hydrogel lens (with EDTA) in Smart Touch packaging in the other eye.'}, {'id': 'FG002', 'title': 'SiH (Without EDTA) in Smart Touch vs H (With EDTA) in Smart Touch', 'description': 'Participants received a Silicone Hydrogel lens (without EDTA) in Smart Touch packaging which was inserted in one eye and a Hydrogel lens (with EDTA) in Smart Touch packaging which was inserted in the other eye.'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Washout (Minimum 48 Hours)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'comment': 'Participants in this group were only assigned to one visit/intervention', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'comment': 'Participants in this group were only assigned to one visit/intervention', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'comment': 'Participants in this group were only assigned to one visit/intervention', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'comment': 'Participants in this group were only assigned to one visit/intervention', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Washout (Minimum 48 Hours)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'comment': 'Participants in this group were only assigned to one visit/intervention', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'comment': 'Participants in this group were only assigned to one visit/intervention', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': '13 participants exited study after first two visits/interventions', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Third Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'comment': 'Participants in this group were only assigned to one visit/intervention', 'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'comment': 'Participants in this group were only assigned to one visit/intervention', 'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '25 subjects were required to complete each of the three study interventions', 'preAssignmentDetails': '25 subjects were enrolled and randomised. Of those randomised, 13 did not complete the third visit/intervention. Therefore an additional 13 subjects were recruited to complete the third intervention only.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'SiH (With EDTA) , Then H (no EDTA), Then SiH (Without EDTA) and H (With EDTA) in Smart Touch', 'description': 'Participants first received a Silicone Hydrogel lens (with EDTA) in Smart Touch packaging which was inserted in one eye and a Silicone Hydrogel lens (with EDTA) in a conventional blister which was inserted in the other eye. After a minimum washout period of 48 hours, they then received a Hydrogel lens (no EDTA) in Smart Touch packaging which was inserted in one eye and a Hydrogel lens in a conventional blister which was inserted in the other eye. After a minimum washout period of 48 hours they then received a Silicone Hydrogel lens (without EDTA) in Smart Touch packaging in one eye and a Hydrogel lens (with EDTA) in Smart Touch packaging in the other eye.'}, {'id': 'BG001', 'title': 'H (no EDTA), Then SiH (With EDTA), Then SiH (Without EDTA) vs H (With EDTA) in Smart Touch', 'description': 'Participants first received a Hydrogel lens (no EDTA) in Smart Touch packaging which was inserted in one eye and a Hydrogel lens in a conventional blister which was inserted in the other eye. After a minimum washout period of 48 hours, they then received a Silicone Hydrogel lens (with EDTA) in Smart Touch packaging which was inserted in one eye and a Silicone Hydrogel lens (with EDTA) in a conventional blister which was inserted in the other eye. After a minimum washout period of 48 hours they then received a Silicone Hydrogel lens (without EDTA) in Smart Touch packaging in one eye and a Hydrogel lens (with EDTA) in Smart Touch packaging in the other eye.'}, {'id': 'BG002', 'title': 'SiH (Without EDTA) in Smart Touch vs H (With EDTA) in Smart Touch', 'description': 'Participants received a Silicone Hydrogel lens (without EDTA) in Smart Touch packaging which was inserted in one eye and a Hydrogel lens (with EDTA) in Smart Touch packaging which was inserted in the other eye.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.8', 'spread': '8.8', 'groupId': 'BG000'}, {'value': '29.8', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '30.1', 'spread': '14.2', 'groupId': 'BG002'}, {'value': '29.9', 'spread': '10.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}, {'title': 'Non-Asian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Australia', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-12-18', 'size': 925901, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-05-24T23:50', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Contralateral study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-03', 'studyFirstSubmitDate': '2017-08-15', 'resultsFirstSubmitDate': '2021-05-25', 'studyFirstSubmitQcDate': '2017-08-15', 'lastUpdatePostDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-10', 'studyFirstPostDateStruct': {'date': '2017-08-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Without Contamination of Contact Lenses', 'timeFrame': 'After 45 minutes of lens wear', 'description': 'Number of Participants Without Contamination of Contact Lenses after 45 minutes of wear'}], 'secondaryOutcomes': [{'measure': 'Bacterial Counts of Worn Contact Lenses', 'timeFrame': 'After 45 minutes of lens wear', 'description': 'Bacterial counts of contact lenses after 45 minutes of wear (CFU count /lens)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Optometry']}, 'referencesModule': {'references': [{'pmid': '33973914', 'type': 'DERIVED', 'citation': 'Tan J, Siddireddy JS, Wong K, Shen Q, Vijay AK, Stapleton F. Factors Affecting Microbial Contamination on the Back Surface of Worn Soft Contact Lenses. Optom Vis Sci. 2021 May 1;98(5):512-517. doi: 10.1097/OPX.0000000000001693.'}]}, 'descriptionModule': {'briefSummary': "This study is a randomized, contralateral, investigator-masked non-dispensing study, to investigate the microbial contamination rates on the back surface of two types of soft contact lenses (hydrogel and silicone hydrogel) extracted from Smart Touch Technology blister packs versus conventional lens packaging after short-term placement on the eye, and to compare the microbial contamination rates of the worn contact lenses to those on the participants' hands/fingers used to conduct lens insertion.", 'detailedDescription': "This will be a prospective, single centre, randomized, contralateral, investigator-masked non-dispensing study. This study requires three visits of approx. 1 hour duration each.\n\nAt the first visit, the order in which the hydrogel (no EDTA) and silicone hydrogel (with EDTA) contact lenses are allocated to the study participants will be randomized. At the second visit, participants will be crossed over to the alternate lens type (hydrogel no EDTA or silicone hydrogel with EDTA).\n\nAt the third visit, participants will be randomly allocated to wear the hydrogel lens (with EDTA) in one eye and the silicone hydrogel lens (no EDTA) in the other eye, both removed from Smart Touch Technology packaging.\n\nAt each visit, participants will be instructed to:\n\n* Wash their hands prior to handling the contact lenses;\n* Swab their thumb and two index fingers of the hand routinely used to conduct contact lens insertion using a sterile cotton swab moistened with sterile preservative free saline for the evaluation of skin microbiota;\n* Follow the manufacturer's guidelines for lens insertion;\n* Open the blister pack and insert the contact lens randomly assigned for the right eye;\n* Open the blister pack and insert the contact lens assigned for the left eye;\n* Contact lenses will be removed aseptically by a masked investigator after 45 minutes of lens wear.\n\nLenses and finger swabs will be analysed for microbial contamination using established routine microbiology protocols. The number and species of organisms will be determined.\n\nA minimum washout period of 48 hours will occur between the study visits."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Able to read and comprehend English and give informed consent as demonstrated by signing a Participant Information Statement and Consent Form;\n* Be at least 18 years old;\n* Experienced soft contact lens wearer;\n* Willing to refrain from wearing contact lenses for 24 hours prior to the scheduled study visit\n\nExclusion Criteria:\n\n* Under 18 years old;\n* Have any active corneal infection, ocular disease or systemic disease that would affect wearing of contact lenses;\n* Use or have a need for any systemic or topical medications which may alter normal ocular findings/are known to affect a participant's ocular health/physiology either in an adverse manner or risk providing a false positive;\n* Have had eye surgery within 12 weeks immediately prior to enrolment for this trial;\n* Have contraindications to contact lens wear;\n* Have a greater than 2 line reduction in habitual visual acuity while wearing the study contact lenses;\n* Be currently enrolled in another clinical trial;\n* Be pregnant (verbal self-report)"}, 'identificationModule': {'nctId': 'NCT03253393', 'briefTitle': 'Smart Touch Non-dispensing Handling Studies', 'organization': {'class': 'OTHER', 'fullName': 'The University of New South Wales'}, 'officialTitle': 'Microbial Contamination Rates on the Back Surface of Soft Contact Lenses in Two Short-term, Randomized, Contralateral Non-dispensing Studies', 'orgStudyIdInfo': {'id': 'SOVS2017-050'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Silicone hydrogel (with EDTA) in Smart Touch vs. in conventional packaging', 'description': 'Silicone hydrogel (with EDTA) in Smart Touch vs. in conventional packaging', 'interventionNames': ['Device: Smart Touch Technology packaging', 'Device: Conventional lens packaging']}, {'type': 'EXPERIMENTAL', 'label': 'Hydrogel (no EDTA) in Smart Touch vs. in conventional packaging', 'description': 'Hydrogel (no EDTA) in Smart Touch vs. in conventional packaging', 'interventionNames': ['Device: Smart Touch Technology packaging', 'Device: Conventional lens packaging']}, {'type': 'EXPERIMENTAL', 'label': 'Silicone hydrogel (no EDTA) vs. hydrogel (with EDTA) in Smart Touch', 'description': 'Silicone hydrogel (no EDTA) vs. hydrogel (with EDTA) in Smart Touch', 'interventionNames': ['Device: EDTA']}], 'interventions': [{'name': 'Smart Touch Technology packaging', 'type': 'DEVICE', 'description': 'hioxifilcon A contact lens in Smart Touch Technology (hydrogel, no EDTA) midafilcon A contact lens in Smart Touch Technology (silicone hydrogel, with EDTA)', 'armGroupLabels': ['Hydrogel (no EDTA) in Smart Touch vs. in conventional packaging', 'Silicone hydrogel (with EDTA) in Smart Touch vs. in conventional packaging']}, {'name': 'Conventional lens packaging', 'type': 'DEVICE', 'description': 'hioxifilcon A contact lens in conventional lens packaging (hydrogel, no EDTA) midafilcon A contact lens in conventional lens packaging (silicone hydrogel, with EDTA)', 'armGroupLabels': ['Hydrogel (no EDTA) in Smart Touch vs. in conventional packaging', 'Silicone hydrogel (with EDTA) in Smart Touch vs. in conventional packaging']}, {'name': 'EDTA', 'type': 'DEVICE', 'description': 'hioxifilcon A contact lens in Smart Touch Technology (hydrogel, with EDTA) midafilcon A contact lens in Smart Touch Technology (silicone hydrogel, no EDTA)', 'armGroupLabels': ['Silicone hydrogel (no EDTA) vs. hydrogel (with EDTA) in Smart Touch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2052', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'School of Optometry and Vision Science', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of New South Wales', 'class': 'OTHER'}, 'collaborators': [{'name': 'Menicon Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Research Fellow', 'investigatorFullName': 'Jacqueline Tan-Showyin', 'investigatorAffiliation': 'The University of New South Wales'}}}}