Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2026-01-01 @ 10:03 AM
Study NCT ID:
NCT05688657
Status:
COMPLETED
Last Update Posted:
2023-12-20
First Post:
2023-01-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of Two Toric Contact Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jvega2@coopervision.com', 'phone': '925-621-3761', 'title': 'Jose A. Vega, OD, MSc, FAAO', 'organization': 'CooperVision'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From dispense up to 15mins on each lens type.', 'description': '\\[Not specified\\]', 'eventGroups': [{'id': 'EG000', 'title': 'Lens A', 'description': 'Participants wore Lens A for 15mins.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lens B', 'description': 'Participants wore Lens B for 15mins.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subjective Handling Ratings on Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lens A', 'description': 'Participants that received Lens A.'}, {'id': 'OG001', 'title': 'Lens B', 'description': 'Participants that received Lens B.'}], 'classes': [{'categories': [{'measurements': [{'value': '92.0', 'spread': '13.1', 'groupId': 'OG000'}, {'value': '93.7', 'spread': '9.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At insertion', 'description': 'Subjective handling ratings on insertion will be measured on a scale from 0-100, where (0= extremely uncomfortable) and 100 = better performance', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '\\[Not Specified\\]'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lens A', 'description': 'All participants wore Lens A for 15 minutes. (Period 1)'}, {'id': 'FG001', 'title': 'Lens B', 'description': 'All participants wore Lens B for 15 minutes. (Period 2)'}], 'periods': [{'title': 'Period 1: Lens A (15 Minutes)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'comment': 'All participants received Lens A in Period 1.', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2: Lens B (15 Minutes)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'All participants received Lens B in Period 2.', 'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Forty-two participants were screened. All participants wore Lens A for first 15 minutes and then wore Lens B for 15 minutes.\n\nAll the participants who were in the study were included in the analysis. (n=42)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'Includes all study participants.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'title': 'Lens A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Lens B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-16', 'size': 1709896, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-07-28T16:10', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'All participants received Lens A and then Lens B in fixed-sequence order.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-29', 'studyFirstSubmitDate': '2023-01-09', 'resultsFirstSubmitDate': '2023-09-19', 'studyFirstSubmitQcDate': '2023-01-09', 'lastUpdatePostDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-19', 'studyFirstPostDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Handling Ratings on Insertion', 'timeFrame': 'At insertion', 'description': 'Subjective handling ratings on insertion will be measured on a scale from 0-100, where (0= extremely uncomfortable) and 100 = better performance'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Astigmatism']}, 'descriptionModule': {'briefSummary': 'The study objective was to compare short-term clinical performance data of two toric contact lenses.', 'detailedDescription': 'The aim of this non-dispensing fitting study was to evaluate the short-term clinical performance of a monthly toric contact lens when compared to a daily disposable toric contact lens after 15 minutes of daily wear each.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is between 18 and 40 years of age (inclusive)\n* Has had a self-reported visual exam in the last two years\n* Is an adapted soft contact lens wearer\n* Is not a habitual wearer of either study lens\n* Has a contact lens spherical prescription between +4.00 to -9.00 (inclusive) best corrected visual acuity of 20/30 or better in either eye\n* Have contact lens prescription of no less than -0.75D of astigmatism and no more than -2.25 D in both eyes.\n* Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.\n* Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.\n* Has clear corneas and no active ocular disease\n* Has read, understood and signed the information consent letter.\n* Patient contact lens refraction should fit within the available parameters of the study lenses.\n* Is willing to comply with the wear schedule (at least 5 days per week, \\> 8 hours/day assuming there are no contraindications for doing so).\n* Is willing to comply with the visit schedule\n\nExclusion Criteria:\n\n* Has a CL prescription outside the range of the available parameters of the study lenses.\n* Has a spectacle cylinder less than -0.75D or more than -2.50 D of cylinder in either eye.\n* Has a history of not achieving comfortable CL wear (5 days per week; \\> 8 hours/day)\n* Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.\n* Presence of clinically significant (grade 2-4) anterior segment abnormalities\n* Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.\n* Slit lamp findings that would contraindicate contact lens wear such as:\n* Pathological dry eye or associated findings\n* Pterygium, pinguecula, or corneal scars within the visual axis\n* Neovascularization \\> 0.75 mm in from of the limbus\n* Giant papillary conjunctivitis (GCP) worse than grade 1\n* Anterior uveitis or iritis (past or present)\n* Seborrheic eczema, Seborrheic conjunctivitis\n* History of corneal ulcers or fungal infections\n* Poor personal hygiene\n* Has a known history of corneal hypoesthesia (reduced corneal sensitivity)\n* Has aphakia, keratoconus or a highly irregular cornea.\n* Has Presbyopia or has dependence on spectacles for near work over the contact lenses.\n* Has undergone corneal refractive surgery.\n* Is participating in any other type of eye related clinical or research study.'}, 'identificationModule': {'nctId': 'NCT05688657', 'briefTitle': 'Clinical Evaluation of Two Toric Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'Clinical Evaluation of Clariti Monthly Toric and Clariti 1 Day Toric', 'orgStudyIdInfo': {'id': 'EX-MKTG-137'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lens A', 'description': 'All participants wore Lens A for 15 minutes (Period 1)', 'interventionNames': ['Device: Lens A']}, {'type': 'EXPERIMENTAL', 'label': 'Lens B', 'description': 'All participants wore Lens B for 15 minutes (Period 2)', 'interventionNames': ['Device: Lens B']}], 'interventions': [{'name': 'Lens A', 'type': 'DEVICE', 'description': 'Monthly Replacement Toric Silicone Hydrogel Contact Lens 15 minutes of daily wear', 'armGroupLabels': ['Lens A']}, {'name': 'Lens B', 'type': 'DEVICE', 'description': 'Daily Disposable Toric Silicone Hydrogel Contact Lens 15 minutes of daily wear', 'armGroupLabels': ['Lens B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06700', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Dr. Ruben Velazquez Private Practice', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Rubén V Guerrero, MSc., FIACLE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dr. Ruben Velazquez Private Practice'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}