Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-27 @ 10:49 PM
Study NCT ID:
NCT04772560
Status:
COMPLETED
Last Update Posted:
2022-03-10
First Post:
2021-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Toric Contact Lens Digital Performance and Comfort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'richdale@uh.edu', 'phone': '713-743-1974', 'title': 'Kathryn Richdale OD, PhD', 'organization': 'University of Houston'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '10 ± 2 days for each intervention', 'description': 'AE information was collected at each study visit', 'eventGroups': [{'id': 'EG000', 'title': 'Toric Contact Lens Wear', 'description': '23 participants had completed the study', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 4, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Spherical Contact Lens Wear', 'description': '23 participants had completed the study', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Corneal staining', 'notes': 'Corneal staining \\> Grade 2 (CCLRU scale)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Near Visual LogMAR Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': '23 participants who had completed the study'}], 'classes': [{'title': 'Toric CL', 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.02', 'groupId': 'OG000'}]}]}, {'title': 'Spherical CL', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.21', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 +/- 2 days', 'description': "High contrast LogMAR visual acuity was assessed at 40 cm using the M\\&S Clinical Trial Suite system (Niles, Illinois, USA). The system was calibrated according to the manufacturer's directions every day, prior to use. Testing was performed binocularly 10+/-2 days after each intervention. The test started at 20/60 and continued until three letters were missed on a line.", 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Dynamic Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': '23 participants who had completed the study'}], 'classes': [{'title': 'Toric CL', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.02', 'groupId': 'OG000'}]}]}, {'title': 'Spherical CL', 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.02', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 +/- 2 days', 'description': 'Dynamic VA was determined using a custom-made iPad application. The subject was instructed to hold the iPad at 40cm and presented with a Landolt C surrounded by crowding bars for 0.3s each, starting from 0.5 LogMAR and progressing to smaller sizes using a staircase threshold method. Testing was performed binocularly 10+/-2 days after each intervention', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Toric Then Spherical', 'description': 'Participants who received toric contact lenses first and spherical lenses after 10 days'}, {'id': 'FG001', 'title': 'Spherical Then Toric', 'description': 'Participants who received spherical contact lenses first and toric lenses after 10 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '30 participants were screened for eligibility between March and December 2021', 'preAssignmentDetails': '23 of 30 participants were randomized. Of those not randomized, 7 did not meet inclusion criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': '23 participants who had completed the study'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24.4', 'spread': '4.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '7 participants were screen failed.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-18', 'size': 534789, 'label': 'Study Protocol and Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'Prot_ICF_000.pdf', 'typeAbbrev': 'Prot_ICF', 'uploadDate': '2022-01-14T19:07', 'hasProtocol': True}, {'date': '2021-12-20', 'size': 66042, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-01-14T19:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-15', 'studyFirstSubmitDate': '2021-02-23', 'resultsFirstSubmitDate': '2022-01-18', 'studyFirstSubmitQcDate': '2021-02-23', 'lastUpdatePostDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-15', 'studyFirstPostDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Near Visual LogMAR Acuity', 'timeFrame': '10 +/- 2 days', 'description': "High contrast LogMAR visual acuity was assessed at 40 cm using the M\\&S Clinical Trial Suite system (Niles, Illinois, USA). The system was calibrated according to the manufacturer's directions every day, prior to use. Testing was performed binocularly 10+/-2 days after each intervention. The test started at 20/60 and continued until three letters were missed on a line."}, {'measure': 'Dynamic Visual Acuity', 'timeFrame': '10 +/- 2 days', 'description': 'Dynamic VA was determined using a custom-made iPad application. The subject was instructed to hold the iPad at 40cm and presented with a Landolt C surrounded by crowding bars for 0.3s each, starting from 0.5 LogMAR and progressing to smaller sizes using a staircase threshold method. Testing was performed binocularly 10+/-2 days after each intervention'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Astigmatism']}, 'descriptionModule': {'briefSummary': 'This study seeks to quantify digital visual performance and subjective visual acceptance of toric contact lenses as compared to spherical lenses in low to moderate astigmatic patients.', 'detailedDescription': 'This study seeks to quantify the near visual performance and subjective visual acceptance of toric contact lenses as compared to spherical lenses in an astigmatic cohort of patients. Primary Hypotheses: Subjects will have better near visual acuity and near visual performance with toric, as opposed to spherical, contact lens correction. As such, the following hypotheses will be tested: H01: There is no statistically significant difference in near visual acuity or near vision performance between contact lenses corrections Ha1: There is a statistically significant difference in visual acuity or vision performance between contact lenses corrections'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 39 years of age (inclusive)\n* pl to -6.00D vertexed sphere power and -0.75 to -1.50D vertexed refractive cylinder OD and OS\n* Current/established full time (\\>6 days week, \\>8 hours/day) soft contact lens wearer\n* Best corrected acuity of 20/25 or better in each eye\n* Self-report of at least 4 hrs/day using digital devices\n* Willing to wear lenses at least 8 hours each day during the study period\n* Able to speak and read English at a high school level / have at least a high school diploma or equivalent (by self-report)\n\nEnclusion Criteria:\n\n* History of ocular pathology or surgery\n* Binocular vision disorder (i.e., tropia, convergence or accommodative insufficiency)\n* Gas permeable lens wear for at least 3 months\n* Symptomatic soft contact lens wearer (CLDEQ-8 score \\<12 at baseline)'}, 'identificationModule': {'nctId': 'NCT04772560', 'briefTitle': 'Toric Contact Lens Digital Performance and Comfort Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Houston'}, 'officialTitle': 'Toric Contact Lens Digital Performance and Comfort Study', 'orgStudyIdInfo': {'id': 'STUDY00002753'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Toric, Then Sphere', 'description': 'Participants who received Toric contact lenses first and spherical lenses after 10 days', 'interventionNames': ['Device: Precision1 for Astigmatism', 'Device: Precision1 Sphere']}, {'type': 'EXPERIMENTAL', 'label': 'Sphere, Then Toric', 'description': 'Participants who received Spherical contact lenses first and Toric lenses after 10 days', 'interventionNames': ['Device: Precision1 for Astigmatism', 'Device: Precision1 Sphere']}], 'interventions': [{'name': 'Precision1 for Astigmatism', 'type': 'DEVICE', 'description': 'Daily disposable soft toric contact lens', 'armGroupLabels': ['Sphere, Then Toric', 'Toric, Then Sphere']}, {'name': 'Precision1 Sphere', 'type': 'DEVICE', 'description': 'Daily disposable soft spherical contact lens', 'armGroupLabels': ['Sphere, Then Toric', 'Toric, Then Sphere']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77204', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Houston College of Optometry', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Kathryn Richdale', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Houston College of Optometry'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kathryn Richdale', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Kathryn Richdale', 'investigatorAffiliation': 'University of Houston'}}}}