Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-01-05 @ 5:22 PM
Study NCT ID:
NCT01870856
Status:
TERMINATED
Last Update Posted:
2014-10-29
First Post:
2013-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lid Wiper Epitheliopathy Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005139', 'term': 'Eyeglasses'}], 'ancestors': [{'id': 'D007909', 'term': 'Lenses'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'Anne Brobst, Clinical Project Lead', 'organization': 'Alcon Research, Ltd.'}, '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': 'Adverse events (AEs) were collected from 15 Jul 2013 to 29 Oct 2013. Reports of AEs were obtained through spontaneous comments from the subjects and through observations by the Investigator as outlined in the study protocol.', 'description': 'An AE was defined as any untoward medical occurrence, unintended disease or injury, or clinical signs in subjects, users or other persons, whether or not related to the investigational device (test article). This analysis group includes all subjects/eyes exposed to investigational products (test and control).', 'eventGroups': [{'id': 'EG000', 'title': 'Spectacles, Stage 1', 'description': "Spectacles per participant's habitual perscription worn for 2 weeks", 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '1-DAY ACUVUE, Stage 1', 'description': 'Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode', 'otherNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Stage 1: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spectacles, Stage 1', 'description': "Spectacles per participant's habitual perscription worn for 2 weeks"}, {'id': 'OG001', 'title': '1-DAY ACUVUE, Stage 1', 'description': 'Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2', 'description': 'LWE was measured by slit lamp evaluation of fluorescein and lissamine green staining of the upper eyelid. LWE was graded on a scale from 0 to 3, where 0=none and 3=severe. The percent of eyes experiencing at least a 1 grade reduction in LWE (from baseline) at the 2-week visit was compared between groups. One eye (study eye) contributed to the analysis.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population includes all randomized subjects who did not meet the critical deviation criteria as specified in the Deviations and Evaluability Plan. Denominator for percentages is the number of subjects with data available at both time points.'}, {'type': 'PRIMARY', 'title': 'Stage 2: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DAILIES TOTAL 1, Stage 2', 'description': 'Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode'}, {'id': 'OG001', 'title': '1-DAY ACUVUE, Stage 2', 'description': 'Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode'}], 'timeFrame': 'Baseline, Week 2', 'description': 'This outcome measure was not evaluated since primary efficacy was not demonstrated.', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stage 2: Change From Baseline in Ocular Discomfort Score (as Measured by SPEED) at 2 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DAILIES TOTAL 1, Stage 2', 'description': 'Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode'}, {'id': 'OG001', 'title': '1-DAY ACUVUE, Stage 2', 'description': 'Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode'}], 'timeFrame': 'Baseline, Week 2', 'description': 'This outcome measure was not evaluated since primary efficacy was not demonstrated.', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Spectacles, Stage 1', 'description': "Spectacles per participant's habitual perscription worn for 2 weeks"}, {'id': 'FG001', 'title': '1-DAY ACUVUE, Stage 1', 'description': 'Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from 23 study centers located in the US.', 'preAssignmentDetails': 'Of the 187 enrolled, 135 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants. Results from Stage 1 were planned to be used to appropriately power Stage 2 of the study. Since primary efficacy cannot be demonstrated in Stage 1, Stage 2 of this study was not conducted.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Spectacles, Stage 1', 'description': "Spectacles per participant's habitual perscription worn for 2 weeks"}, {'id': 'BG001', 'title': '1-DAY ACUVUE, Stage 1', 'description': 'Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.1', 'spread': '10.9', 'groupId': 'BG000'}, {'value': '34.1', 'spread': '9.4', 'groupId': 'BG001'}, {'value': '34.1', 'spread': '10.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This analysis population includes all participants/eyes exposed to investigational products (test and control).'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 187}}, 'statusModule': {'whyStopped': 'Primary efficacy was not demonstrated in Stage 1', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-28', 'studyFirstSubmitDate': '2013-06-04', 'resultsFirstSubmitDate': '2014-10-24', 'studyFirstSubmitQcDate': '2013-06-04', 'lastUpdatePostDateStruct': {'date': '2014-10-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-28', 'studyFirstPostDateStruct': {'date': '2013-06-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stage 1: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks', 'timeFrame': 'Baseline, Week 2', 'description': 'LWE was measured by slit lamp evaluation of fluorescein and lissamine green staining of the upper eyelid. LWE was graded on a scale from 0 to 3, where 0=none and 3=severe. The percent of eyes experiencing at least a 1 grade reduction in LWE (from baseline) at the 2-week visit was compared between groups. One eye (study eye) contributed to the analysis.'}, {'measure': 'Stage 2: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks', 'timeFrame': 'Baseline, Week 2', 'description': 'This outcome measure was not evaluated since primary efficacy was not demonstrated.'}], 'secondaryOutcomes': [{'measure': 'Stage 2: Change From Baseline in Ocular Discomfort Score (as Measured by SPEED) at 2 Weeks', 'timeFrame': 'Baseline, Week 2', 'description': 'This outcome measure was not evaluated since primary efficacy was not demonstrated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ocular discomfort', 'Contact lenses', 'Myopia'], 'conditions': ['Lid Wiper Epitheliopathy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of contact lens lubricity on lid wiper epitheliopathy (LWE) in symptomatic contact lens wearers. LWE is defined as an alteration of that portion of the marginal conjunctival epithelium of the upper eyelid that wipes the ocular surface during blinking.', 'detailedDescription': 'This study will be conducted in two stages. In Stage 1, participants will wear either spectacles or contact lenses for two weeks to determine the impact of interruption of contact lens wear on LWE. In Stage 2, a second cohort of participants will wear one of two contact lens brands for two weeks, and LWE and ocular discomfort will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sign Informed Consent document.\n* Severe lid wiper epitheliopathy (upper lid) in either eye.\n* Currently wearing spherical daily disposable soft contact lenses or daily wear soft contact lenses in both eyes with at least 3 months of contact lens wearing experience.\n* Symptomatic as determined by the SPEED questionnaire.\n* Willing to follow visit schedule.\n* Habitual contact lens power with the range of -1.00 to -6.00 diopters (D) with best corrected distance visual acuity greater than or equal to 20/25 in each eye.\n* Astigmatism less than or equal to 0.75D.\n* Possess spectacles which provide visual acuity of at least 20/25 in each eye.\n* Willing and able to complete daily diaries.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Eye injury within 12 weeks immediately prior to enrollment.\n* Any ocular condition that would contraindicate contact lens wear.\n* Any use of systemic or ocular medications that would contraindicate contact lens wear, as determined by the investigator.\n* Currently wearing toric or multifocal soft contact lenses.\n* Participation in a clinical study (including contact lens or contact lens care product) within the previous 30 days.\n* Routinely sleeps in lenses for at least 1 night per week.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01870856', 'briefTitle': 'Lid Wiper Epitheliopathy Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Evaluation of Lid Wiper Epitheliopathy With and Without Daily Disposable Contact Lenses', 'orgStudyIdInfo': {'id': 'C-13-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Spectacles, Stage 1', 'description': "Spectacles per participant's habitual perscription worn for 2 weeks", 'interventionNames': ['Device: Spectacles']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1-DAY ACUVUE, Stage 1', 'description': 'Etafilcon A contact lenses worn in both eyes at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode', 'interventionNames': ['Device: Etafilcon A contact lenses']}, {'type': 'EXPERIMENTAL', 'label': 'DAILIES TOTAL1, Stage 2', 'description': 'Delefilcon A contact lenses worn in both eyes at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode', 'interventionNames': ['Device: Delefilcon A contact lenses']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1-DAY ACUVUE, Stage 2', 'description': 'Etafilcon A contact lenses worn in both eyes at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode', 'interventionNames': ['Device: Etafilcon A contact lenses']}], 'interventions': [{'name': 'Spectacles', 'type': 'DEVICE', 'description': "Per participant's habitual prescription", 'armGroupLabels': ['Spectacles, Stage 1']}, {'name': 'Delefilcon A contact lenses', 'type': 'DEVICE', 'otherNames': ['DAILIES TOTAL1®'], 'description': 'Silicone hydrogel single vision contact lenses', 'armGroupLabels': ['DAILIES TOTAL1, Stage 2']}, {'name': 'Etafilcon A contact lenses', 'type': 'DEVICE', 'otherNames': ['1-DAY ACUVUE®'], 'description': 'Hydrogel single vision contact lenses', 'armGroupLabels': ['1-DAY ACUVUE, Stage 1', '1-DAY ACUVUE, Stage 2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Anne Brobst, OD, FAAO', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}