Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-01-23 @ 4:29 AM
Study NCT ID:
NCT02248766
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2014-09-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Performance of Habitual Wearers of Avaira Toric When Refitted With Clariti Toric 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': 'robert.montes@uv.es', 'phone': '34-9635-44764', 'title': 'Robert Montes-Mico, O.D., PhD', 'organization': 'Optometry Research Group (GIO) University of Valencia'}, 'certainAgreement': {'otherDetails': "Principal Investigators are NOT employed by the organization sponsoring the study.\n\nThere is an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.\n\nThe investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '4 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Enfilcon A', 'description': 'All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens\n\nenfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Somofilcon A', 'description': 'All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens\n\nsomofilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Visual Acuity - Enfilcon A and Somofilcon A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens\n\nenfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens'}, {'id': 'OG001', 'title': 'Somofilcon A at 1 Week', 'description': 'All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.'}, {'id': 'OG002', 'title': 'Somofilcon A at 2 Week', 'description': 'All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.'}, {'id': 'OG003', 'title': 'Somofilcon A at 4 Week', 'description': 'All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.'}], 'classes': [{'title': 'Oculus Dexter (OD)', 'categories': [{'measurements': [{'value': '-0.013', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.013', 'spread': '0.03', 'groupId': 'OG001'}, {'value': '-0.010', 'spread': '0.03', 'groupId': 'OG002'}, {'value': '-0.023', 'spread': '0.03', 'groupId': 'OG003'}]}]}, {'title': 'Oculus Sinister (OS)', 'categories': [{'measurements': [{'value': '-0.010', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.010', 'spread': '0.03', 'groupId': 'OG001'}, {'value': '-0.017', 'spread': '0.03', 'groupId': 'OG002'}, {'value': '-0.017', 'spread': '0.03', 'groupId': 'OG003'}]}]}, {'title': 'Binocular', 'categories': [{'measurements': [{'value': '-0.033', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.033', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '-0.040', 'spread': '0.05', 'groupId': 'OG002'}, {'value': '-0.040', 'spread': '0.05', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 week, 2 week, 4 week', 'description': 'Monocular and binocular logMAR visual acuity for enfilcon A / somofilcon A assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week.', 'unitOfMeasure': 'logMar', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Subjective Assessments- Enfilcon A and Somofilcon A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens\n\nenfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens'}, {'id': 'OG001', 'title': 'Somofilcon A at 1 Week', 'description': 'All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.'}, {'id': 'OG002', 'title': 'Somofilcon A at 2 Week', 'description': 'All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.'}, {'id': 'OG003', 'title': 'Somofilcon A at 4 Week', 'description': 'All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.'}], 'classes': [{'title': 'Comfort on insertion', 'categories': [{'measurements': [{'value': '8.53', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '8.43', 'spread': '0.62', 'groupId': 'OG001'}, {'value': '8.07', 'spread': '0.64', 'groupId': 'OG002'}, {'value': '7.50', 'spread': '0.86', 'groupId': 'OG003'}]}]}, {'title': 'Comfort prior to removal', 'categories': [{'measurements': [{'value': '8.13', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '7.83', 'spread': '0.80', 'groupId': 'OG001'}, {'value': '7.20', 'spread': '0.71', 'groupId': 'OG002'}, {'value': '6.70', 'spread': '0.99', 'groupId': 'OG003'}]}]}, {'title': 'Comfort overall', 'categories': [{'measurements': [{'value': '8.10', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '7.63', 'spread': '0.77', 'groupId': 'OG001'}, {'value': '7.10', 'spread': '0.76', 'groupId': 'OG002'}, {'value': '6.20', 'spread': '1.10', 'groupId': 'OG003'}]}]}, {'title': 'Dryness during the day', 'categories': [{'measurements': [{'value': '8.47', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '8.27', 'spread': '0.64', 'groupId': 'OG001'}, {'value': '7.63', 'spread': '0.88', 'groupId': 'OG002'}, {'value': '7.43', 'spread': '1.13', 'groupId': 'OG003'}]}]}, {'title': 'Dryness prior to removal', 'categories': [{'measurements': [{'value': '8.23', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '8.00', 'spread': '0.79', 'groupId': 'OG001'}, {'value': '7.33', 'spread': '0.80', 'groupId': 'OG002'}, {'value': '7.03', 'spread': '0.96', 'groupId': 'OG003'}]}]}, {'title': 'Overall dryness', 'categories': [{'measurements': [{'value': '8.03', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '7.77', 'spread': '0.73', 'groupId': 'OG001'}, {'value': '7.13', 'spread': '0.86', 'groupId': 'OG002'}, {'value': '6.70', 'spread': '1.23', 'groupId': 'OG003'}]}]}, {'title': 'Handling', 'categories': [{'measurements': [{'value': '9.23', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '9.20', 'spread': '0.55', 'groupId': 'OG001'}, {'value': '9.17', 'spread': '0.46', 'groupId': 'OG002'}, {'value': '9.00', 'spread': '0.53', 'groupId': 'OG003'}]}]}, {'title': 'Overall lens fit', 'categories': [{'measurements': [{'value': '7.93', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '7.90', 'spread': '0.78', 'groupId': 'OG001'}, {'value': '7.77', 'spread': '0.76', 'groupId': 'OG002'}, {'value': '8.13', 'spread': '0.70', 'groupId': 'OG003'}]}]}, {'title': 'Overall vision satisfaction', 'categories': [{'measurements': [{'value': '8.30', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '8.10', 'spread': '0.69', 'groupId': 'OG001'}, {'value': '7.60', 'spread': '0.67', 'groupId': 'OG002'}, {'value': '7.77', 'spread': '0.62', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 week, 2 week, 4 week', 'description': 'Subjective assessments for: comfort, dryness, handling, overall lens fit, and overall vision satisfaction. Enfilcon A was assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week. Scale(s): comfort (0=very poor; 10=excellent), dryness (0=very dry; 10=no dryness), handling (0=very difficult; 10=very easy), overall lens fit (0=very unstable; 10=very stable), overall vision satisfaction (0=very unsatisfied; 10=very satisfied)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Enfilcon A / Somofilcon A', 'description': 'All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens\n\nenfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens\n\nsomofilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Enfilcon A / Somofilcon A', 'description': 'All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens\n\nenfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens\n\nsomofilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23.4', 'spread': '2.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Spain', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'This study had a total of 30 participants. The 30 participants were evaluated with the habitual lenses (enfilcon A) and then evaluated with the (somofilcon A) lenses.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-19', 'studyFirstSubmitDate': '2014-09-23', 'resultsFirstSubmitDate': '2016-02-23', 'studyFirstSubmitQcDate': '2014-09-24', 'lastUpdatePostDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-02-23', 'studyFirstPostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Acuity - Enfilcon A and Somofilcon A', 'timeFrame': 'Baseline, 1 week, 2 week, 4 week', 'description': 'Monocular and binocular logMAR visual acuity for enfilcon A / somofilcon A assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week.'}, {'measure': 'Subjective Assessments- Enfilcon A and Somofilcon A', 'timeFrame': 'Baseline, 1 week, 2 week, 4 week', 'description': 'Subjective assessments for: comfort, dryness, handling, overall lens fit, and overall vision satisfaction. Enfilcon A was assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week. Scale(s): comfort (0=very poor; 10=excellent), dryness (0=very dry; 10=no dryness), handling (0=very difficult; 10=very easy), overall lens fit (0=very unstable; 10=very stable), overall vision satisfaction (0=very unsatisfied; 10=very satisfied)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Astigmatism']}, 'descriptionModule': {'briefSummary': 'The aim of this dispensing study is to evaluate the clinical performance of existing wearers of Avaira toric lenses following a refit with Clariti toric over 1 month of daily wear.', 'detailedDescription': "This is a 30-subject, prospective dispensing study comparing the clinical performance of the subjects' habitual Avaira toric lenses following a refit with Clariti toric lenses. Subject's habitual Avaira toric lenses will be evaluated at the first visit and then re-fitted with a pair of Clariti toric lenses for 1 month of daily wear. After the dispensing visit, subjects will return for evaluations at 1 week, 2 weeks and 4 weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, '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 Avaira toric contact lens (CL) wearer (at least 1 week of wear in Avaira toric)\n* Has a contact lens spherical prescription between +6.00 to - 8.00 (inclusive)\n* Have no less than 0.75D of astigmatism and no more than 1.75 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* Is not a habitual wearer of Avaira toric lenses\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 -1.75 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\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': 'NCT02248766', 'briefTitle': 'Clinical Performance of Habitual Wearers of Avaira Toric When Refitted With Clariti Toric Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'Clinical Performance of Habitual Wearers of Avaira Toric (Enfilcon A) When Refitted With Clariti Toric (Somofilcon A) Lenses for 1 Month.', 'orgStudyIdInfo': {'id': 'EX-MKTG-53'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'enfilcon A', 'description': 'All participants are habitual wearers of enfilcon A lens who are refitted with somofilcon A lens', 'interventionNames': ['Device: somofilcon A']}, {'type': 'EXPERIMENTAL', 'label': 'somofilcon A', 'description': 'All participants are habitual wearers of enfilcon A lens who are refitted with somofilcon A lens', 'interventionNames': ['Device: somofilcon A']}], 'interventions': [{'name': 'somofilcon A', 'type': 'DEVICE', 'description': 'somofilcon A lens', 'armGroupLabels': ['enfilcon A', 'somofilcon A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Valencia', 'country': 'Spain', 'facility': 'Optometry Research Group (GIO) - Optics Department, University of Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Robert Montés-Mico, OD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Optometry Research Group (GIO)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}