Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT01338402
Status:
COMPLETED
Last Update Posted:
2014-02-20
First Post:
2011-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Performance of AIR OPTIX® COLORS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-19', 'studyFirstSubmitDate': '2011-04-15', 'studyFirstSubmitQcDate': '2011-04-18', 'lastUpdatePostDateStruct': {'date': '2014-02-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Acuity', 'timeFrame': 'Phase 2: Up to Week 4'}, {'measure': 'Corneal Staining', 'timeFrame': 'Phase 2: Up to Week 4'}, {'measure': 'Conjunctival Staining', 'timeFrame': 'Phase 2: Up to Week 4'}, {'measure': 'Surface Regularity Index (SRI)', 'timeFrame': 'Up to Phase 2, Week 4'}, {'measure': 'Surface Asymmetry Index (SAI)', 'timeFrame': 'Up to Phase 2, Week 4'}, {'measure': 'Subjective ratings', 'timeFrame': 'Phase 2: Up to Week 4'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to assess the ocular response to and performance of the cosmetically printed silicone hydrogel contact lens AIR OPTIX® COLORS compared to FRESHLOOK® COLORBLENDS.', 'detailedDescription': 'The study was conducted in two phases. Phase 1 was an adaptation phase where participants wore AIR OPTIX® AQUA contact lenses bilaterally (same product in both eyes) on a daily wear basis for 1 week. In Phase 2, participants wore AIR OPTIX® COLORS and FRESHLOOK® COLORBLENDS contact lenses contralaterally (different product in each eye) on a daily wear basis for 4 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Full legal capacity to volunteer;\n* Read and sign information and consent letter;\n* Willing and able to follow instructions and maintain the appointment schedule;\n* Ocular examination in the last two years;\n* Currently wears soft contact lenses on a daily wear basis;\n* Contact lens prescription between -1.50 diopters and -5.00 diopters;\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Any ocular disease;\n* Any systemic condition that may affect a study outcome variable;\n* Any systemic or topical medications that may affect ocular health;\n* Known sensitivity to the diagnostic pharmaceuticals used in the study;\n* Unable to achieve an acceptable fit with the study lenses;\n* Anisometropia \\>1.00 diopter or astigmatism \\>0.75 diopter;\n* Use of lubricating/rewetting eye drops.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01338402', 'briefTitle': 'Evaluation of the Performance of AIR OPTIX® COLORS', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'orgStudyIdInfo': {'id': 'P-368-C-108'}, 'secondaryIdInfos': [{'id': 'P/363/10/C', 'type': 'OTHER', 'domain': 'University of Waterloo'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'AIR OPTIX® AQUA', 'description': 'Lotrafilcon B contact lenses worn in both eyes on a daily wear basis for one week in Phase 1.', 'interventionNames': ['Device: Lotrafilcon B contact lens']}, {'type': 'EXPERIMENTAL', 'label': 'AIR OPTIX® COLORS', 'description': 'Lotrafilcon B contact lens with color randomly assigned to one eye, with phemfilcon A contact lens with color in the fellow eye for contralateral wear. Both products worn on a daily wear basis for 4 weeks in Phase 2. A replacement phemfilcon A lens was dispensed at the Week 2 visit.', 'interventionNames': ['Device: Lotrafilcon B contact lens with color']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FRESHLOOK® COLORBLENDS', 'description': 'Phemfilcon A contact lens with color randomly assigned to one eye, with lotrafilcon B contact lens with color in the fellow eye for contralateral wear. Both products worn on a daily wear basis for 4 weeks in Phase 2. A replacement phemfilcon A lens was dispensed at the Week 2 visit.', 'interventionNames': ['Device: Phemfilcon A contact lens with color']}], 'interventions': [{'name': 'Lotrafilcon B contact lens', 'type': 'DEVICE', 'otherNames': ['AIR OPTIX® AQUA'], 'description': 'Silicone hydrogel contact lens', 'armGroupLabels': ['AIR OPTIX® AQUA']}, {'name': 'Lotrafilcon B contact lens with color', 'type': 'DEVICE', 'otherNames': ['AIR OPTIX® COLORS'], 'description': 'Silicone hydrogel contact lens with color', 'armGroupLabels': ['AIR OPTIX® COLORS']}, {'name': 'Phemfilcon A contact lens with color', 'type': 'DEVICE', 'otherNames': ['FRESHLOOK® COLORBLENDS'], 'description': 'Hydrogel contact lens with color', 'armGroupLabels': ['FRESHLOOK® COLORBLENDS']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N2L 3G1', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Centre for Contact Lens Research, University of Waterloo', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}], 'overallOfficials': [{'name': 'Desmond Fonn, MOptom, FAAO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Waterloo Centre for Contact Lens Research'}, {'name': 'Lyndon Jones, PhD, FCOptom, FAAO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Waterloo Centre for Contact Lens Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CIBA VISION', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Waterloo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}