Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-02-25 @ 8:27 PM
Study NCT ID:
NCT02676258
Status:
COMPLETED
Last Update Posted:
2016-07-07
First Post:
2016-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Comparison of Two Daily Disposable Silicone Hydrogel Soft Contact Lens
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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-05', 'studyFirstSubmitDate': '2016-01-30', 'studyFirstSubmitQcDate': '2016-02-03', 'lastUpdatePostDateStruct': {'date': '2016-07-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Acuity', 'timeFrame': 'over all follow-up visits for 3 month study period', 'description': 'logMAR visual acuity (VA) over all visits.'}], 'secondaryOutcomes': [{'measure': 'Any Slit Lamp Finding > Grade 2', 'timeFrame': 'over all follow-up visits for the 3 month study period', 'description': 'All dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=sever findings.'}, {'measure': 'Subjective Response to Comfort, symptoms and complaints', 'timeFrame': 'over all follow-up visits for the 3 month study period', 'description': 'subjective ratings of comfort, symptom and complaints using a scale of 0=severe stinging/Burning to 10=No stinging/Burning for each eye; 0 represented the least favorable rating and a 100 represented the most favorable rating.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['silicone hydrogel daily disposable soft contact lens'], 'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate a new daily disposable silicone hydrogel soft contact lens by comparing to an existing daily disposable soft contact lens.', 'detailedDescription': 'This study is designed to evaluate the performance of the olifilcon B contact lens to demonstrate substantial equivalence to the narafilcon A for regulatory requirement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject should have normal eyes and use no ocular medications\n* Subject with -1.00 to -10.00 D myopia, less than 2.00 D astigmatism\n* VA correctable to Log MAR 0.1 or better.\n* Willing to comply with all study procedures and be available for the duration of the study.\n* Provide signed and dated informed consent form.\n\nExclusion Criteria:\n\n* Subjects have history of allergies that would contraindicate "normal" contact lens wear.\n* Subjects have other active ocular or systemic disease such as, but not limited to : anterior uveitis (past or present), glaucoma, Sjögren\'s syndrome, lupus erythematosus, sclerodermas, keratoconus or type II diabetes.\n* Subjects have medications that would contraindicate contact lens wear.\n* Currently pregnant (to the best of the subject\'s knowledge), is lactating or is planning a pregnancy within the next 3 month.\n* Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.\n* Any active participation in another clinical trial within 30 days prior to this study.\n* The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.\n* A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates or fungal infections.\n* A history of papillary conjunctivitis that has interfered with contact lens wear.'}, 'identificationModule': {'nctId': 'NCT02676258', 'briefTitle': 'Clinical Comparison of Two Daily Disposable Silicone Hydrogel Soft Contact Lens', 'organization': {'class': 'INDUSTRY', 'fullName': 'Visco Vision Inc.'}, 'officialTitle': 'A Prospective Randomized Controlled Study to Evaluate the Clinical Performance of Si-Hy Silicone Hydrogel Soft Contact Lens', 'orgStudyIdInfo': {'id': '1030313M'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Si-Hy soft contact lens', 'description': 'olifilon B daily disposable soft contact lens', 'interventionNames': ['Device: Si-Hy (olifilcon B)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vistakon soft contact lens', 'description': 'narafilcon A daily disposable soft contact lens', 'interventionNames': ['Device: Vistakon (narafilcon A)']}], 'interventions': [{'name': 'Si-Hy (olifilcon B)', 'type': 'DEVICE', 'description': 'Wear Si-Hy silicone hydrgel soft contact lens for 3 months', 'armGroupLabels': ['Si-Hy soft contact lens']}, {'name': 'Vistakon (narafilcon A)', 'type': 'DEVICE', 'description': 'Wear Vistakon soft contact lens for 3 months', 'armGroupLabels': ['Vistakon soft contact lens']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'MayKay Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Huey Chuan Cheng, MD MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mackay Memorial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Visco Vision Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}