Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT00940459
Status:
COMPLETED
Last Update Posted:
2016-11-16
First Post:
2009-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Subjective and Conjunctival Response to Edge Design of Different Silicone Hydrogels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-15', 'studyFirstSubmitDate': '2009-07-14', 'studyFirstSubmitQcDate': '2009-07-15', 'lastUpdatePostDateStruct': {'date': '2016-11-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Circumlimbal Conjunctival Staining (CCS)', 'timeFrame': 'After 10 days of wear'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['contact lenses', 'conjunctival staining', 'contact lens wear'], 'conditions': ['Contact Lenses']}, 'referencesModule': {'references': [{'pmid': '22146704', 'type': 'RESULT', 'citation': 'Maissa C, Guillon M, Garofalo RJ. Contact lens-induced circumlimbal staining in silicone hydrogel contact lenses worn on a daily wear basis. Eye Contact Lens. 2012 Jan;38(1):16-26. doi: 10.1097/ICL.0b013e31823bad46.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the effect of different contact lens edge designs on the circumlimbal conjunctiva.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Minimum age of 18 years old\n* Adapted contact lens wearer\n* Sign informed consent\n* Normal eyes with the exception of the need for visual correction\n* Astigmatism less than or equal to -0.75 diopter\n* Spherical prescription range between -10.00 and +6.00 diopters\n* Other protocol-defined inclusion criteria may apply\n\nExclusion Criteria:\n\n* Any known sensitivity to the test articles used in the study\n* Monocular vision\n* Lid or conjunctival infections or abnormalities\n* Conjunctival staining greater than Grade 1\n* Corneal staining greater than Grade 2\n* Corneal edema or opacifications\n* Aphakia\n* Any previous corneal surgery\n* Iritis\n* Recent significant changes in visual acuity\n* Ocular disease that contraindicates contact lens wear\n* Tarsal abnormalities greater than Grade 2\n* Any ophthalmic medication\n* Any systemic medication or condition that might affect the subject's participation in the study\n* Chronic upper respiratory infections or colds\n* Pregnancy or planning to become pregnant\n* Lactation\n* Seasonal allergies\n* Known infections or immunosuppressive disease\n* Participation in other studies\n* Other protocol-defined exclusion criteria may apply"}, 'identificationModule': {'nctId': 'NCT00940459', 'briefTitle': 'Subjective and Conjunctival Response to Edge Design of Different Silicone Hydrogels', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Subjective and Conjunctival Response to Edge Design of Different Silicone Hydrogels', 'orgStudyIdInfo': {'id': 'M-09-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acuvue Oasys', 'description': 'One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.', 'interventionNames': ['Device: Senofilcon A contact lens (Acuvue Oasys)', 'Device: Contact lens care system (EasySept)']}, {'type': 'EXPERIMENTAL', 'label': 'Biofinity', 'description': 'One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.', 'interventionNames': ['Device: Comfilcon A contact lens (Biofinity)', 'Device: Contact lens care system (EasySept)']}, {'type': 'EXPERIMENTAL', 'label': 'Air Optix', 'description': 'One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.', 'interventionNames': ['Device: Lotrafilcon B contact lens (Air Optix)', 'Device: Contact lens care system (EasySept)']}, {'type': 'EXPERIMENTAL', 'label': 'PureVision', 'description': 'One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.', 'interventionNames': ['Device: Balafilcon A contact lens (PureVision)', 'Device: Contact lens care system (EasySept)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Acuvue 2', 'description': 'One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.', 'interventionNames': ['Device: Etafilcon A contact lens (Acuvue 2)', 'Device: Contact lens care system (EasySept)']}], 'interventions': [{'name': 'Senofilcon A contact lens (Acuvue Oasys)', 'type': 'DEVICE', 'otherNames': ['ACUVUE® OASYS™'], 'description': 'Silicone hydrogel contact lens CE-marked for the intended usage.', 'armGroupLabels': ['Acuvue Oasys']}, {'name': 'Comfilcon A contact lens (Biofinity)', 'type': 'DEVICE', 'otherNames': ['Biofinity®'], 'description': 'Silicone hydrogel contact lens CE-marked for the intended usage.', 'armGroupLabels': ['Biofinity']}, {'name': 'Lotrafilcon B contact lens (Air Optix)', 'type': 'DEVICE', 'otherNames': ['Air Optix®'], 'description': 'Silicone hydrogel contact lens CE-marked for the intended usage.', 'armGroupLabels': ['Air Optix']}, {'name': 'Balafilcon A contact lens (PureVision)', 'type': 'DEVICE', 'otherNames': ['PureVision®'], 'description': 'Silicone hydrogel contact lens CE-marked for the intended usage.', 'armGroupLabels': ['PureVision']}, {'name': 'Etafilcon A contact lens (Acuvue 2)', 'type': 'DEVICE', 'otherNames': ['ACUVUE® 2'], 'description': 'Hydrogel contact lens CE-marked for the intended usage.', 'armGroupLabels': ['Acuvue 2']}, {'name': 'Contact lens care system (EasySept)', 'type': 'DEVICE', 'otherNames': ['EasySept'], 'description': 'Contact lens care system CE-marked for the intended usage.', 'armGroupLabels': ['Acuvue 2', 'Acuvue Oasys', 'Air Optix', 'Biofinity', 'PureVision']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'Optometric Technology Group Ltd', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}