Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-31 @ 1:28 AM
Study NCT ID:
NCT04254003
Status:
COMPLETED
Last Update Posted:
2020-03-18
First Post:
2020-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Performance Evaluation of Two Daily Disposable Silicone Hydrogel Toric Contact Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-17', 'studyFirstSubmitDate': '2020-01-31', 'studyFirstSubmitQcDate': '2020-02-03', 'lastUpdatePostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of DT1 toric lenses with axis orientation within ±30° from the intended axis, 10 min after lens insertion', 'timeFrame': 'Day 1, 10 minutes after lens insertion, each product', 'description': 'A slit lamp will be used to observe axis orientation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['toric contact lens', 'daily disposable', 'silicone hydrogel contact lens', 'axis orientation', 'astigmatism'], 'conditions': ['Refractive Errors']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the rotational behavior of DT1 Toric contact lenses.', 'detailedDescription': 'This is a single visit, non-dispense study where subjects will be exposed to the test and control lenses for approximately 1 hour each.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current wearer of any commercial soft daily wear contact lens with at least 3 months of wearing experience with a minimum wearing time of 5 days per week and 8 hours per day.\n* Requiring contact lens (manifest refraction) of a cylindrical power of -0.75 to -2.50 diopter cylinder (DC).\n* Best corrected distance visual acuity 20/25 or better Snellen in each eye (as determined by manifest refraction at screening).\n* Willing to NOT use rewetting/lubricating drops at any time during the study. Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator.\n* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.\n* History of refractive surgery or plan to have refractive surgery during the study or irregular cornea in either eye.\n* Eye injury in either eye within 12 weeks immediately prior to enrollment for this trial.\n\nOther protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT04254003', 'briefTitle': 'Clinical Performance Evaluation of Two Daily Disposable Silicone Hydrogel Toric Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Clinical Performance Evaluation of Two Daily Disposable Silicone Hydrogel Toric Contact Lenses', 'orgStudyIdInfo': {'id': 'CLO870-C003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Test, then Control', 'description': 'DT1 Toric contact lenses worn first, followed by AO1DfA contact lenses, as randomized. Each product will be worn in both eyes for approximately 1 hour.', 'interventionNames': ['Device: DT1 Toric contact lenses', 'Device: AO1DfA contact lenses']}, {'type': 'OTHER', 'label': 'Control, then Test', 'description': 'AO1DfA contact lenses worn first, followed by DT1 Toric contact lenses, as randomized. Each product will be worn in both eyes for approximately 1 hour.', 'interventionNames': ['Device: DT1 Toric contact lenses', 'Device: AO1DfA contact lenses']}], 'interventions': [{'name': 'DT1 Toric contact lenses', 'type': 'DEVICE', 'otherNames': ['Test', 'DAILIES TOTAL1 for Astigmatism (DT1 Toric)'], 'description': 'Delefilcon A contact lenses for the optical correction of astigmatism in people with healthy eyes with or without refractive ametropia (myopia or hyperopia)', 'armGroupLabels': ['Control, then Test', 'Test, then Control']}, {'name': 'AO1DfA contact lenses', 'type': 'DEVICE', 'otherNames': ['Control', 'Acuvue Oasys 1-Day for Astigmatism (AO1DfA)'], 'description': 'Senofilcon A contact lenses for the optical correction of astigmatism in people with healthy eyes with or without refractive ametropia (myopia or hyperopia)', 'armGroupLabels': ['Control, then Test', 'Test, then Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Alcon Investigative Site CT-11', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '55344', 'city': 'Eden Prairie', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Alcon Investigative Site CT-27', 'geoPoint': {'lat': 44.85469, 'lon': -93.47079}}], 'overallOfficials': [{'name': 'Clinical Trial Lead, Vision Care', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}