Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2026-02-17 @ 4:50 PM
Study NCT ID:
NCT04032457
Status:
COMPLETED
Last Update Posted:
2020-10-06
First Post:
2019-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PAVES Benchmarking Pilot Study of Daily Disposable Contact Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2021-10-04', 'unreleaseDate': '2021-10-05'}, {'resetDate': '2021-11-04', 'mcpReleaseN': 4, 'releaseDate': '2021-10-05'}], 'estimatedResultsFirstSubmitDate': '2021-10-04'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012030', 'term': 'Refractive Errors'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER'], 'maskingDescription': 'Clinician masking achieved by clinic coordinator dispensing lenses. Open label to participants.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized cross-over after 1 week of wear of two lens brands.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-05', 'studyFirstSubmitDate': '2019-04-17', 'studyFirstSubmitQcDate': '2019-07-23', 'lastUpdatePostDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Lens Preference', 'timeFrame': 'Visit 3 - Approximately 2 weeks', 'description': 'Subjective preference for either lens intervention or no preference. Likert question with forced preference for Test or Benchmark lens or no preference.'}], 'secondaryOutcomes': [{'measure': '8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) score', 'timeFrame': 'Visit 2 and 3 - Approximately 1 and 2 weeks, respectively', 'description': 'Difference in CLDEQ-8 score with treatments relative to score with habitual lenses. The scale on the 8-item CLDEQ-8 instrument is from 1 to 33, with each item having a possible 4 or 5 points.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Contact Lens'], 'conditions': ['Refractive Errors']}, 'descriptionModule': {'briefSummary': 'The study will compare the short-term clinical performance and wearer and practitioner acceptability in a pilot study of a new-to-market spherical silicone hydrogel daily disposable soft contact lens (SiHyDD) to three (3) benchmark soft daily disposable lenses (DD) and, subsequently, of a new-to-market hydrogel spherical daily disposable (HydDD) soft contact lens to three (3) other hydrogel daily disposable lenses. .\n\nThe primary outcome variables for this study are subjective comfort and lens preference.', 'detailedDescription': 'The objective of the study is to compare the short-term clinical performance and wearer and practitioner acceptability in a pilot study of a new-to-market spherical silicone hydrogel olifilcon B with Tangible Coating daily disposable soft contact lens (SiHyDD) to three (3) benchmark soft daily disposable lenses (DD) and, subsequently, of a new-to-market hydrogel etafilcon A with Tangible Coating spherical daily disposable (HydDD) soft contact lens to three (3) other hydrogel daily disposable lenses. .\n\nThe primary outcome variables for this study are subjective comfort and lens preference.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy full-time wearers of spherical daily disposable contact lenses\n* Vision correctable to 20/30 with spherical lenses in powers from +3.00 to +1.00 DS and from -1.00 to -7.00 DS\n* Visual acuity corrected to at least 20/30 with spherical contact lens\n\nExclusion Criteria:\n\n* Participating in another clinical trial\n* Vision not correctable to 20/30 with lens powers listed above'}, 'identificationModule': {'nctId': 'NCT04032457', 'acronym': 'PAVES', 'briefTitle': 'PAVES Benchmarking Pilot Study of Daily Disposable Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vision Service Plan'}, 'officialTitle': 'PAVES Benchmarking Pilot Study of Daily Disposable Contact Lenses', 'orgStudyIdInfo': {'id': 'VS-19-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A1 - SiHyDD to Moist', 'description': '1 week of Test SiHyDD contact lenses followed by cross over to 1 week of 1-DAY ACUVUE® Moist contact lenses.', 'interventionNames': ['Device: Phase A - olifilcon B with Tangible Coatings']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'A2 - Moist to SiHyDD', 'description': '1 week of 1-DAY ACUVUE® Moist contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses.', 'interventionNames': ['Device: Phase A - olifilcon B with Tangible Coatings']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'A3 - SiHyDD to OASDD', 'description': '1 week of Test SiHyDD contact lenses followed by cross over to 1 week of ACUVUE® OASYS 1-Day contact lenses.', 'interventionNames': ['Device: Phase A - olifilcon B with Tangible Coatings']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'A4 - OASDD to SiHyDD', 'description': '1 week of ACUVUE® OASYS 1-Day contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses.', 'interventionNames': ['Device: Phase A - olifilcon B with Tangible Coatings']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'A5 - SiHyDD to DT1', 'description': '1 week of Test SiHyDD contact lenses followed by cross over to 1 week of Alcon DAILIES TOTAL 1® contact lenses.', 'interventionNames': ['Device: Phase A - olifilcon B with Tangible Coatings']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'A6 - DT1 to SiHyDD', 'description': '1 week of Alcon DAILIES TOTAL 1® contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses.', 'interventionNames': ['Device: Phase A - olifilcon B with Tangible Coatings']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B1 - HydDD to Moist', 'description': '1 week of Test HydDD contact lenses followed by cross over to 1 week of 1-DAY ACUVUE® Moist contact lenses.', 'interventionNames': ['Device: Phase B - etafilcon A with Tangible Coatings']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B2 - Moist to HydDD', 'description': '1 week of 1-DAY ACUVUE® Moist contact lenses followed by cross over to 1 week of Test HydDD contact lenses.', 'interventionNames': ['Device: Phase B - etafilcon A with Tangible Coatings']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B3 - HydDD to BioTrue', 'description': '1 week of Test HydDD contact lenses followed by cross over to 1 week of BIOTRUE ONEday® contact lenses.', 'interventionNames': ['Device: Phase B - etafilcon A with Tangible Coatings']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B4 - BioTrue to HydDD', 'description': '1 week of BIOTRUE ONEday® contact lenses followed by cross over to 1 week of Test HydDD contact lenses.', 'interventionNames': ['Device: Phase B - etafilcon A with Tangible Coatings']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B5 - HydDD to AqCom+', 'description': '1 week of Test HydDD contact lenses followed by cross over to 1 week of DAILIES® AquaComfort PLUS® contact lenses.', 'interventionNames': ['Device: Phase B - etafilcon A with Tangible Coatings']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B6 - AqCom+ to HydDD', 'description': '1 week of DAILIES® AquaComfort PLUS® contact lenses followed by cross over to 1 week of Test HydDD contact lenses.', 'interventionNames': ['Device: Phase B - etafilcon A with Tangible Coatings']}], 'interventions': [{'name': 'Phase A - olifilcon B with Tangible Coatings', 'type': 'DEVICE', 'description': 'Daily disposable silicone hydrogel contact lens', 'armGroupLabels': ['A1 - SiHyDD to Moist', 'A2 - Moist to SiHyDD', 'A3 - SiHyDD to OASDD', 'A4 - OASDD to SiHyDD', 'A5 - SiHyDD to DT1', 'A6 - DT1 to SiHyDD']}, {'name': 'Phase B - etafilcon A with Tangible Coatings', 'type': 'DEVICE', 'description': 'Daily disposable hydrogel contact lens', 'armGroupLabels': ['B1 - HydDD to Moist', 'B2 - Moist to HydDD', 'B3 - HydDD to BioTrue', 'B4 - BioTrue to HydDD', 'B5 - HydDD to AqCom+', 'B6 - AqCom+ to HydDD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30324', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Ross Eyecare', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60714', 'city': 'Niles', 'state': 'Illinois', 'country': 'United States', 'facility': 'Professional Eye Care Center', 'geoPoint': {'lat': 42.01892, 'lon': -87.80284}}, {'zip': '46032', 'city': 'Carmel', 'state': 'Indiana', 'country': 'United States', 'facility': 'RevolutionEyes', 'geoPoint': {'lat': 39.97837, 'lon': -86.11804}}, {'zip': '01810', 'city': 'Andover', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Andover Optometry on Central', 'geoPoint': {'lat': 42.65843, 'lon': -71.137}}, {'zip': '43081', 'city': 'Westerville', 'state': 'Ohio', 'country': 'United States', 'facility': 'Professional VisionCare', 'geoPoint': {'lat': 40.12617, 'lon': -82.92907}}, {'zip': '37027', 'city': 'Brentwood', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Primary Eyecare Group, PC', 'geoPoint': {'lat': 36.03312, 'lon': -86.78278}}], 'overallOfficials': [{'name': 'Robin L Chalmers, OD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Trial Consultant'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vision Service Plan', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Foresight Regulatory Strategies, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-10-04', 'type': 'RELEASE'}, {'date': '2021-10-05', 'type': 'UNRELEASE'}], 'unpostedResponsibleParty': 'Vision Service Plan'}}}}