Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2026-02-20 @ 11:26 AM
Study NCT ID:
NCT02251561
Status:
COMPLETED
Last Update Posted:
2015-06-10
First Post:
2014-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of Opti-Free III (FID 109182) Compared to Opti-Free Plus® in Japan
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'title': 'Director, Clinical & Regulatory Affairs, Division of Medical Affairs', 'organization': 'Alcon Japan, Ltd.'}, 'certainAgreement': {'otherDetails': 'Sponsor reserves the right of prior review of any publication or presentation of information related to the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for the duration of the study.', 'description': 'This analysis population includes all subjects who used the study products. In this contralateral study, number at risk is presented by eye.', 'eventGroups': [{'id': 'EG000', 'title': 'FID 109182', 'description': 'Senofilcon A contact lens pre-soaked in FID 109182 worn in 1 eye for 2 hours', 'otherNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Opti-Free Plus', 'description': 'Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in 1 eye for 2 hours', 'otherNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Participants Scoring ≥ 2 for Corneal Staining Density With Fluorescein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FID 109182', 'description': 'Senofilcon A contact lens pre-soaked in FID 109182 worn in 1 eye for 2 hours'}, {'id': 'OG001', 'title': 'Opti-Free Plus', 'description': 'Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in 1 eye for 2 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '92.6', 'groupId': 'OG000'}, {'value': '22.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1, after 2 hours of wear', 'description': 'The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining density was evaluated for each eye individually against representative pictures and scored on a 0-3 scale (0=No staining; 1=Staining with low density; 2=Staining with moderate density; 3=Staining with severe density). Proportion of participants is reported as a percentage.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population includes all subjects who used the study products and had examination/observation data after use.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Scoring ≥ 2 for Corneal Staining Area With Fluorescein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FID 109182', 'description': 'Senofilcon A contact lens pre-soaked in FID 109182 worn in 1 eye for 2 hours'}, {'id': 'OG001', 'title': 'Opti-Free Plus', 'description': 'Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in 1 eye for 2 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '92.6', 'groupId': 'OG000'}, {'value': '44.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1, after 2 hours of wear', 'description': 'The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining area was evaluated for each eye individually against representative pictures and scored on a 0-3 scale \\[0=No staining; 1=Staining with small area (1 to 25% of corneal surface); 2=Staining with medium area (26 to 50% of corneal surface); 3=Staining with large area (51% of corneal surface or greater)\\]. Proportion of participants is reported as a percentage.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population includes all subjects who used the study products and had examination/observation data after use.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FID 109182/Opti-Free Plus', 'description': 'Senofilcon A contact lens pre-soaked in FID 109182 in 1 eye, with senofilcon A contact lens pre-soaked in Opti-Free Plus in the fellow eye. Lenses worn contralaterally for 2 hours.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were enrolled from one study site located in Japan.', 'preAssignmentDetails': 'Of the 36 subjects enrolled in the study, 8 were exited prior to product exposure \\[did not meet eligibility criteria (5), and subject withdrawal (3)\\]. This reporting group includes all subjects who used the study products (28).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'FID 109182/Opti-Free Plus', 'description': 'Senofilcon A contact lens pre-soaked in FID 109182 in 1 eye, with senofilcon A contact lens pre-soaked in Opti-Free Plus in the fellow eye. Lenses worn contralaterally for 2 hours.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.0', 'spread': '7.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'This analysis population includes all subjects who used the study products.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-03', 'studyFirstSubmitDate': '2014-09-25', 'resultsFirstSubmitDate': '2015-05-20', 'studyFirstSubmitQcDate': '2014-09-25', 'lastUpdatePostDateStruct': {'date': '2015-06-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-06-03', 'studyFirstPostDateStruct': {'date': '2014-09-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants Scoring ≥ 2 for Corneal Staining Density With Fluorescein', 'timeFrame': 'Day 1, after 2 hours of wear', 'description': 'The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining density was evaluated for each eye individually against representative pictures and scored on a 0-3 scale (0=No staining; 1=Staining with low density; 2=Staining with moderate density; 3=Staining with severe density). Proportion of participants is reported as a percentage.'}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants Scoring ≥ 2 for Corneal Staining Area With Fluorescein', 'timeFrame': 'Day 1, after 2 hours of wear', 'description': 'The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining area was evaluated for each eye individually against representative pictures and scored on a 0-3 scale \\[0=No staining; 1=Staining with small area (1 to 25% of corneal surface); 2=Staining with medium area (26 to 50% of corneal surface); 3=Staining with large area (51% of corneal surface or greater)\\]. Proportion of participants is reported as a percentage.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['contact lenses', 'contact lens solution', 'corneal staining', 'fluorescein'], 'conditions': ['Corneal Staining']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare an investigational contact lens care product (FID 109182) to a commercially available contact lens product (Opti-Free Plus®) for corneal staining when used with Acuvue® Oasys® contact lenses. The contact lenses will be pre-soaked in the products for 24-48 hours prior to a 2-hour contralateral wear period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Soft contact lenses habitual wearer, both eyes.\n* Voluntarily sign Informed Consent.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Unable to tolerate the ingredients in Opti-Free® and similar contact lens care products.\n* Potential use of eye drops during the study, including over-the-counter products, except for artificial tear eye drops.\n* Eye infection, blepharitis, iris inflammation, or severe eye inflammation.\n* Corneal staining greater than Grade 1 at baseline.\n* Pregnant, lactating, or intend to become pregnant during study period.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02251561', 'briefTitle': 'Clinical Evaluation of Opti-Free III (FID 109182) Compared to Opti-Free Plus® in Japan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Clinical Evaluation of Opti-Free III Compared to Opti-Free Plus®', 'orgStudyIdInfo': {'id': 'CVKK2013-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FID 109182', 'description': 'Senofilcon A contact lens pre-soaked in FID 109182 worn in the right or left eye as randomized for 2 hours', 'interventionNames': ['Device: FID 109182', 'Device: Senofilcon A contact lens']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Opti-Free Plus', 'description': 'Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in the fellow eye for 2 hours', 'interventionNames': ['Device: Opti-Free Plus', 'Device: Senofilcon A contact lens']}], 'interventions': [{'name': 'FID 109182', 'type': 'DEVICE', 'otherNames': ['Opti-Free III'], 'description': 'Investigational multipurpose contact lens cleaning and disinfecting solution', 'armGroupLabels': ['FID 109182']}, {'name': 'Opti-Free Plus', 'type': 'DEVICE', 'otherNames': ['Opti-Free Plus®'], 'description': 'Commercially available multipurpose contact lens cleaning and disinfecting solution', 'armGroupLabels': ['Opti-Free Plus']}, {'name': 'Senofilcon A contact lens', 'type': 'DEVICE', 'otherNames': ['Acuvue® Oasys®'], 'description': 'Commercially available silicone hydrogel contact lens', 'armGroupLabels': ['FID 109182', 'Opti-Free Plus']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Tsunemitsu Senta', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Japan, Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}