Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2026-01-01 @ 11:25 PM
Study NCT ID:
NCT01197859
Status:
COMPLETED
Last Update Posted:
2020-08-12
First Post:
2010-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Three Month Clinical Evaluation of the Contamac 74% Silicone Hydrogel Contact Lens
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-10', 'studyFirstSubmitDate': '2010-09-02', 'studyFirstSubmitQcDate': '2010-09-08', 'lastUpdatePostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess performance variables as compared to the predicate device during follow-up visits to demonstrate safety and efficacy.', 'timeFrame': '3 months', 'description': 'The clinical study will assess the following performance variables as compared to the predicate device during 5 follow-up visits over a 3 month period to demonstrate safety and efficacy: Sphere-cyl Refraction and VA, Keratometry, Comfort, Handling, Symptoms, Over-Refraction and VA, Lens Fit, Lens Deposits, and Slit Lamp Findings.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vision Correction']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the clinical performance of the contamac silicone hydrogel contact lens with a predicate device (Cooper Vision Biofinity).', 'detailedDescription': 'The purpose of this study is to evaluate the clinical performance of the Contamac lens in comparison with a currently marketed silicone hydrogel: Biofinity® (CooperVision). This is a 3-month, open-label, bilateral, parallel group, randomised, daily wear study. Approx. two-thirds of the subjects will wear the Contamac Silicone Hydrogel lens in both eyes while the other third will wear control lenses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* existing contact lens wearer\n* read and signed statement of informed consent\n* has clear central cornea\n* requires spherical distance correction\n\nExclusion Criteria:\n\n* has worn RGP contact lenses within the last 30 days\n* is using any ocular medication\n* has had refractive surgery\n* has an infectious disease\n* is pregnant or lactating\n* is participating in another clinical research study'}, 'identificationModule': {'nctId': 'NCT01197859', 'briefTitle': 'Three Month Clinical Evaluation of the Contamac 74% Silicone Hydrogel Contact Lens', 'organization': {'class': 'INDUSTRY', 'fullName': 'Contamac Ltd'}, 'officialTitle': 'Three Month Clinical Evaluation of the Contamac 74% Silicone Hydrogel Contact Lens', 'orgStudyIdInfo': {'id': 'CCSH-1901'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Contamac 74% silicone hydrogel contact lens', 'description': 'Definitive Contact Lens', 'interventionNames': ['Device: Definitive Contact Lens']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cooper Vision Biofinity', 'description': 'Biofinity Contact Lens', 'interventionNames': ['Device: Biofinity']}], 'interventions': [{'name': 'Definitive Contact Lens', 'type': 'DEVICE', 'description': 'Daily wear contact lens', 'armGroupLabels': ['Contamac 74% silicone hydrogel contact lens']}, {'name': 'Biofinity', 'type': 'DEVICE', 'description': 'Daily wear contact lens', 'armGroupLabels': ['Cooper Vision Biofinity']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'GU9 7EN', 'city': 'Farnham', 'state': 'Surry', 'country': 'United Kingdom', 'facility': 'Vision Care Research', 'geoPoint': {'lat': 51.21444, 'lon': -0.80054}}], 'overallOfficials': [{'name': 'Graeme Young', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vision Care Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Contamac Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}