Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-02-26 @ 3:17 AM
Study NCT ID:
NCT02965820
Status:
COMPLETED
Last Update Posted:
2018-07-12
First Post:
2016-11-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
OPTI-FREE® PureMoist® for Presbyopic Contact Lens Wearers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011305', 'term': 'Presbyopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'Head, CDMA Vision Care Franchise', 'organization': 'Alcon, A Novartis Division'}, 'certainAgreement': {'otherDetails': 'Sponsor reserves the right of prior review of any publication or presentation of information related to the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 through study completion, an average of 60 days', 'description': 'An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.', 'eventGroups': [{'id': 'EG000', 'title': 'OFPM', 'description': 'All subjects exposed to OPTI-FREE® PureMoist® multi-purpose contact lens solution', 'otherNumAtRisk': 121, 'deathsNumAtRisk': 121, 'otherNumAffected': 0, 'seriousNumAtRisk': 121, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'HMPS', 'description': 'All subjects exposed to habitual multi-purpose contact lens solution', 'otherNumAtRisk': 120, 'deathsNumAtRisk': 120, 'otherNumAffected': 0, 'seriousNumAtRisk': 120, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Knee operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFPM', 'description': "OPTI-FREE® PureMoist® multi-purpose contact lens solution used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles."}, {'id': 'OG001', 'title': 'HMPS', 'description': "Subject's habitual multi-purpose contact lens solution used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles."}], 'classes': [{'categories': [{'measurements': [{'value': '13.4', 'spread': '7.42', 'groupId': 'OG000'}, {'value': '15.8', 'spread': '7.87', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.0030', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 30, each product', 'description': 'CLDEQ-8 score (assessment of contact lens discomfort) was obtained by adding the numerical responses to each of 8 items. Individual scales ranged from 0-4, 0-5, and 1-6, with a resultant overall score from 1 minimum to 37 maximum. A lower CLDEQ-8 score indicates less frequent or less intense symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set with non-missing responses'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OFPM/HMPS', 'description': "OPTI-FREE® PureMoist® (OFPM) multi-purpose contact lens solution in Period 1, followed by subject's habitual multi-purpose contact lens solution (HMPS) in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles."}, {'id': 'FG001', 'title': 'HMPS/OFPM', 'description': "Subject's habitual multi-purpose contact lens solution in Period1, followed by OPTI-FREE® PureMoist® contact lens solution in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles."}], 'periods': [{'title': 'Period 1, First 30 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2, Second 30 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'One subject discontinued due to an AE after completion of Period 1 but before beginning Period 2.', 'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subjects were recruited from 8 study centers located in the United States.', 'preAssignmentDetails': 'Of the 122 enrolled, 1 subject was exited as a screen failure prior to randomization. This reporting group includes all randomized subjects (121).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall', 'description': 'OFPM and HMPS used during Period 1 and Period 2 in a crossover assignment.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.7', 'spread': '5.32', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '92', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '119', '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': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '101', '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'}], 'populationDescription': 'This analysis population includes all subjects exposed to study lens care products (Full Analysis Set).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-01-03', 'size': 2312172, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-03-27T15:19', 'hasProtocol': True}, {'date': '2016-12-11', 'size': 839587, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-03-27T15:20', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-15', 'studyFirstSubmitDate': '2016-11-15', 'resultsFirstSubmitDate': '2018-03-20', 'studyFirstSubmitQcDate': '2016-11-15', 'lastUpdatePostDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-27', 'studyFirstPostDateStruct': {'date': '2016-11-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30', 'timeFrame': 'Day 30, each product', 'description': 'CLDEQ-8 score (assessment of contact lens discomfort) was obtained by adding the numerical responses to each of 8 items. Individual scales ranged from 0-4, 0-5, and 1-6, with a resultant overall score from 1 minimum to 37 maximum. A lower CLDEQ-8 score indicates less frequent or less intense symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Contact lens induced dryness'], 'conditions': ['Presbyopia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate OPTI-FREE® PureMoist® (OFPM) compared to non-HYDRAGLYDE® multi-purpose contact lens solutions in presbyopes currently wearing soft contact lenses and experiencing symptoms of dryness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must sign an informed consent document;\n* Current adapted two-week/monthly replacement soft contact lens wearers (at least 2 months) with symptoms of contact lens induced dryness;\n* Near spectacle add of +0.50 or greater;\n* Best corrected visual acuity (BCVA) to 20/30 or better in each eye at distance;\n* Willing to wear lenses for a minimum of 5 days per week, 6 hours per day, and attend all study visits;\n* Currently using a non-Alcon multi-purpose solution to care for lenses (at least 2 months);\n* Use of digital devices (eg, smart phone, tablet, laptop computer, or desktop computer) for 20 consecutive minutes at least twice a week and willing to continue the same pattern for the duration of the study;\n* Other protocol-specific inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Extended wear contact lens wearer (sleeps in lenses 1 or more nights per week);\n* Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear as determined by the investigator;\n* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator, including use of any topical ocular medications that would require instillation during contact lens wear;\n* Monocular (only 1 eye with functional vision) or fit with only 1 lens;\n* Known sensitivity to any ingredients in OFPM;\n* Prior refractive surgery;\n* History of herpetic keratitis, ocular surgery, or irregular cornea;\n* Pathological dry eye that precludes contact lens wear;\n* Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;\n* Participation in any clinical study within 30 days of Visit 1;\n* Currently using or have not discontinued Restasis®, Xiidra® or a topical steroid within the past 7 days;\n* Other protocol-specific exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02965820', 'briefTitle': 'OPTI-FREE® PureMoist® for Presbyopic Contact Lens Wearers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Clinical Study of OPTI-FREE® PureMoist® for Presbyopic Contact Lens Wearers', 'orgStudyIdInfo': {'id': 'LCO115-P001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'OFPM, then HMPS', 'description': "OPTI-FREE® PureMoist® multi-purpose contact lens solution in Period 1, followed by subject's habitual multi-purpose contact lens solution (HMPS) in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.", 'interventionNames': ['Device: Opti-Free® PureMoist® contact lens solution', 'Device: Habitual Multi-Purpose Contact Lens Solution', 'Device: Habitual Contact Lenses']}, {'type': 'OTHER', 'label': 'HMPS, then OFPM', 'description': "Subject's habitual multi-purpose contact lens solution in Period1, followed by OPTI-FREE® PureMoist® contact lens solution in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.", 'interventionNames': ['Device: Opti-Free® PureMoist® contact lens solution', 'Device: Habitual Multi-Purpose Contact Lens Solution', 'Device: Habitual Contact Lenses']}], 'interventions': [{'name': 'Opti-Free® PureMoist® contact lens solution', 'type': 'DEVICE', 'otherNames': ['OPTI-FREE® PureMoist®'], 'armGroupLabels': ['HMPS, then OFPM', 'OFPM, then HMPS']}, {'name': 'Habitual Multi-Purpose Contact Lens Solution', 'type': 'DEVICE', 'armGroupLabels': ['HMPS, then OFPM', 'OFPM, then HMPS']}, {'name': 'Habitual Contact Lenses', 'type': 'DEVICE', 'description': "Subject's habitual contact lens brand worn in a daily wear modality for 30 days.", 'armGroupLabels': ['HMPS, then OFPM', 'OFPM, then HMPS']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Clinical Project Manager, CPM', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon, A Novartis Division'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon, a Novartis Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}