Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-27 @ 5:00 PM
Study NCT ID:
NCT02356692
Status:
COMPLETED
Last Update Posted:
2020-11-23
First Post:
2012-04-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Comfort Evaluation of Two Marketed Spherical 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': 'dsiegel@coopervision.com', 'phone': '602 485 3414', 'title': 'Donald Siegel, OD', 'organization': 'CooperVision'}, 'certainAgreement': {'otherDetails': 'Recipient agress to maintain Confidential Information in strict confidence, not to disclose Confidential Information to any third parties and no to use Confidential Information for any purposes execpt for Business Purpose.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From dispense up to 15 minutes for both study lenses.', 'eventGroups': [{'id': 'EG000', 'title': 'Enfilcon A', 'description': 'participants randomized to wear the test lens (enfilcon A) in one eye.\n\nEnfilcon A: contact lens', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Senofilcon A', 'description': 'participants randomized to wear the control lens (senofilcon A) in the one eye.\n\nSenofilcon A: contact lens', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Comfort at Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'participants randomized to wear the (enfilcon A) test lens in one eye.\n\nenfilcon A: contact lens'}, {'id': 'OG001', 'title': 'Senofilcon A', 'description': 'participants randomized to wear the senofilcon A (control) lens in the one eye.\n\nsenofilcon A: contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "Participant's response for comfort at insertion. (Scale 0-10; 0=poor/intolerable, 10=comfortable/ cannot be felt) Obtained at baseline.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}, {'type': 'PRIMARY', 'title': 'Comfort at Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'participants randomized to wear the (enfilcon A) test lens in one eye.\n\nenfilcon A: contact lens'}, {'id': 'OG001', 'title': 'Senofilcon A', 'description': 'participants randomized to wear the senofilcon A control lens in one eye.\n\nsenofilcon A: contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 minutes', 'description': "Participant's response for comfort at 15 minutes. (Scale 0-10; 0=poor/intolerable, 10=comfortable/ cannot be felt) Obtained at 15 minutes.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'PRIMARY', 'title': 'Comfort Preference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study Group', 'description': 'participants randomized to wear the (enfilcon A) test lens in one eye and the senofilcon A (control) in the other eye.\n\nEnfilcon A: contact lens Senofilcon A: contact lens'}], 'classes': [{'title': 'Prefer Enfilcon A', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Prefer Senofilcon A', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': "Participant's response for comfort preference of enfilcon A (test) lens, senofilcon A(control) lens at insertion.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'n=59, one participant would not choose a preference at the initial insertion as both lenses were the same to them.'}, {'type': 'PRIMARY', 'title': 'Comfort Preference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study Group', 'description': 'participants randomized to wear the (enfilcon A) test lens in one eye and the senofilcon A (control) in the other eye.\n\nEnfilcon A: contact lens Senofilcon A: contact lens'}], 'classes': [{'title': 'Preferred Enfilcon A', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Preferred Senofilcon A', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 minutes', 'description': "Participant's response for comfort of enfilcon A (test) lens, senofilcon A (control) lens at 15 minutes wear.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Enfilcon A', 'description': 'participants randomized to wear the (enfilcon A) test lens in one eye.\n\nEnfilcon A: contact lens'}, {'id': 'FG001', 'title': 'Senofilcon A', 'description': 'participants randomized to wear the senofilcon A contact lens (control) in the one eye.\n\nSenofilcon A: contact lens'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '60', 'numSubjects': '60'}, {'groupId': 'FG001', 'numUnits': '60', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '60', 'numSubjects': '60'}, {'groupId': 'FG001', 'numUnits': '60', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Eyes'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study Group', 'description': 'participants randomized to wear the (enfilcon A) test lens in one eye and the senofilcon A (control) in the other eye.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '60', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-30', 'studyFirstSubmitDate': '2012-04-30', 'resultsFirstSubmitDate': '2020-10-05', 'studyFirstSubmitQcDate': '2015-02-04', 'lastUpdatePostDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-30', 'studyFirstPostDateStruct': {'date': '2015-02-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comfort at Insertion', 'timeFrame': 'Baseline', 'description': "Participant's response for comfort at insertion. (Scale 0-10; 0=poor/intolerable, 10=comfortable/ cannot be felt) Obtained at baseline."}, {'measure': 'Comfort at Insertion', 'timeFrame': '15 minutes', 'description': "Participant's response for comfort at 15 minutes. (Scale 0-10; 0=poor/intolerable, 10=comfortable/ cannot be felt) Obtained at 15 minutes."}, {'measure': 'Comfort Preference', 'timeFrame': 'Baseline', 'description': "Participant's response for comfort preference of enfilcon A (test) lens, senofilcon A(control) lens at insertion."}, {'measure': 'Comfort Preference', 'timeFrame': '15 minutes', 'description': "Participant's response for comfort of enfilcon A (test) lens, senofilcon A (control) lens at 15 minutes wear."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Astigmatism']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to investigate the overall clinical comfort performance of enfilcon A (test) lens and senofilcon A (control) lens over 15-minutes of lens wear.', 'detailedDescription': 'This was a non-dispensing, single-masked, randomized, contralateral study comparing Enfilcon A (test) against Senofilcon A (control). Each subject was randomized to wear the test lens in one eye and the control lens in the other eye.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '38 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Based on his/her knowledge, must be in good general health.\n2. Be 18 to 38 years old.\n3. Be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluation.\n4. Read, indicate understanding of, and sign Written Informed Consent.\n5. Be existing or successfully adapted users of soft contact lenses, but not currently wearing either of the study lenses (Avaira or Oasys) being evaluated in this trial.\n6. Require a visual correction in both eyes.\n7. Require a prescription between +8.00D and -12.00D and have less than or equal to 0.75D of astigmatism in both eyes.\n8. Achieve visual acuity of 20/25 or better in each eye with a spherical contact lens prescription.\n9. Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:\n\n * No amblyopia.\n * No evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes).\n * lamp findings Grade 2 or above: corneal edema, tarsal abnormalities, and conjunctival injection).\n * No other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea \\[infiltrates\\], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology).\n * No aphakia.\n\nExclusion Criteria:\n\n1. 0.75D or greater of refractive astigmatism in either eye.\n2. Presbyopic or current monovision contact lens wear.\n3. Cannot be currently wearing either lenses (Avaira or Oasys).\n4. Presence of clinically significant (grade 2-4) anterior segment abnormalities; inflammation such as iritis; or any infection of the eye, lids, or associated structures.\n5. Presence of ocular or systemic disease or need of medication which might interfere with contact lens wear.\n6. 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 the limbus\n * Giant papillary conjunctivitis (GPC) worse than Grade 1\n * Anterior uveitis or iritis (past or present)\n * Seborrheic eczema, seborrheic conjunctivitis\n * History of corneal ulcer or fungal infections\n * Poor personal hygiene\n * A known history of corneal hypoesthesia (reduced corneal sensitivity)\n7. Contact Lens best corrected Snellen visual acuities (VA) worse than 20/30.\n8. Aphakia, Keratoconus or a highly irregular cornea.'}, 'identificationModule': {'nctId': 'NCT02356692', 'briefTitle': 'Clinical Comfort Evaluation of Two Marketed Spherical Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'Clinical Comfort Evaluation of Two Marketed Spherical Contact Lenses', 'orgStudyIdInfo': {'id': 'EX-MKTG-38-MTF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'enfilcon A', 'description': 'participants randomized to wear the Enfilcon A (test) lens in one eye and Senofilcon A (control) lens in the other eye.', 'interventionNames': ['Device: enfilcon A', 'Device: senofilcon A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'senofilcon A', 'description': 'participants randomized to wear the Enfilcon A (test) lens in one eye and Senofilcon A (control) lens in the other eye.', 'interventionNames': ['Device: enfilcon A', 'Device: senofilcon A']}], 'interventions': [{'name': 'enfilcon A', 'type': 'DEVICE', 'description': 'Test lens', 'armGroupLabels': ['enfilcon A', 'senofilcon A']}, {'name': 'senofilcon A', 'type': 'DEVICE', 'description': 'Control lens', 'armGroupLabels': ['enfilcon A', 'senofilcon A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Schaeffer Eye Associates', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Beaches Family Eyecare', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '70503', 'city': 'Lafayette', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Todays Eyecare, LLC', 'geoPoint': {'lat': 30.22409, 'lon': -92.01984}}], 'overallOfficials': [{'name': 'Donald Siegel, OD', 'role': 'STUDY_CHAIR', 'affiliation': 'CooperVision, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}