Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT01267656
Status:
COMPLETED
Last Update Posted:
2020-09-30
First Post:
2010-12-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Evaluate a Contact Lens Lubricating and Rewetting Drop
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'susan.harris@bauschhealth.com', 'title': 'Study Director', 'organization': 'Bausch Health'}, 'certainAgreement': {'otherDetails': 'Contact sponsor directly for details.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '2 weeks', 'description': 'Adverse events were not coded. Therefore source vocabulary is not applicable.', 'eventGroups': [{'id': 'EG000', 'title': 'Lubricating and Rewetting Drops', 'description': 'Lubricating and Rewetting Drops, after one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week.\n\nLubricating and Rewetting Drops: Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.', 'otherNumAtRisk': 166, 'otherNumAffected': 0, 'seriousNumAtRisk': 166, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'AMO Blink Contacts Lubricant Eye Drops', 'description': 'AMO Blink Contacts Lubricant Eye Drops, After one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week\n\nAMO Blink Contacts Lubricant Eye Drops: Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.', 'otherNumAtRisk': 166, 'otherNumAffected': 0, 'seriousNumAtRisk': 166, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Eyes With Graded Slit Lamp Findings Greater Than Grade 2.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '330', 'groupId': 'OG000'}, {'value': '330', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubricating and Rewetting Drops', 'description': 'Lubricating and Rewetting Drops, after one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week.\n\nLubricating and Rewetting Drops: Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.'}, {'id': 'OG001', 'title': 'AMO Blink Contacts Lubricant Eye Drops', 'description': 'AMO Blink Contacts Lubricant Eye Drops, After one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week\n\nAMO Blink Contacts Lubricant Eye Drops: Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'At 1 week follow up', 'description': 'Slit lamp findings for epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded 0 to 4, with 0 = none to 4 = severe. The outcome measure is any finding \\> grade 2, across abnormalities.', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'There were 330 eyes evaluable for slit lamp findings in each group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lubricating and Rewetting Drops Then AMO Blink Contacts Lubric', 'description': 'Lubricating and Rewetting Drops, after one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week.\n\nLubricating and Rewetting Drops: Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.\n\nAMO Blink Contacts Lubricant Eye Drops, After one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week AMO Blink Contacts Lubricant Eye Drops: Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.'}, {'id': 'FG001', 'title': 'AMO Blink Contacts Lubricant Eye Drops Then Lubricating and Re', 'description': 'AMO Blink Contacts Lubricant Eye Drops, After one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week\n\nAMO Blink Contacts Lubricant Eye Drops: Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.\n\nLubricating and Rewetting Drops, after one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week.\n\nLubricating and Rewetting Drops: Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '83'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '82'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'There were 168 participants enrolled and 166 participants treated. The study was a cross-over study, so the 166 participants received both treatment groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall', 'description': 'The study was a cross-over study, so the 166 treated participants received both treatment groups.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.4', 'spread': '9.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '120', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated participants were included in the analysis population.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-29', 'studyFirstSubmitDate': '2010-12-27', 'resultsFirstSubmitDate': '2020-08-21', 'studyFirstSubmitQcDate': '2010-12-27', 'lastUpdatePostDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-29', 'studyFirstPostDateStruct': {'date': '2010-12-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Eyes With Graded Slit Lamp Findings Greater Than Grade 2.', 'timeFrame': 'At 1 week follow up', 'description': 'Slit lamp findings for epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded 0 to 4, with 0 = none to 4 = severe. The outcome measure is any finding \\> grade 2, across abnormalities.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['rewetting', 'lubricating', 'eye drops'], 'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the product performance of investigational lubricating and rewetting drops.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.\n* Adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.\n* Use a lens care system on a regular basis.\n* Wear their habitual lenses (or be willing to wear lenses) a minimum of 8 hours per day.\n* Willing to use drops 4 times per day.\n\nExclusion Criteria:\n\n* Participating in a conflicting study.\n* An active ocular disease, any corneal infiltrative response, or are using any ocular medications.\n* Any scar or neovascularization within the central 4mm of the cornea.\n* Any grade 2 or greater finding during the slit lamp examination\n* Using any systemic or topical medications that will affect ocular physiology or lens performance.\n* Aphakic.\n* Amblyopic.\n* Allergic to any component in the study care products.\n* Have had any corneal surgery.'}, 'identificationModule': {'nctId': 'NCT01267656', 'briefTitle': 'Study to Evaluate a Contact Lens Lubricating and Rewetting Drop', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch & Lomb Incorporated'}, 'officialTitle': 'Study to Evaluate the Product Feasibility of a Contact Lens Lubricating and Rewetting Drop', 'orgStudyIdInfo': {'id': '684E'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lubricating and Rewetting Drops', 'description': 'Lubricating and Rewetting Drops, after one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week.', 'interventionNames': ['Device: Lubricating and Rewetting Drops']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'AMO Blink Contacts Lubricant Eye Drops', 'description': 'AMO Blink Contacts Lubricant Eye Drops, After one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week', 'interventionNames': ['Device: AMO Blink Contacts Lubricant Eye Drops']}], 'interventions': [{'name': 'Lubricating and Rewetting Drops', 'type': 'DEVICE', 'description': 'Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.', 'armGroupLabels': ['Lubricating and Rewetting Drops']}, {'name': 'AMO Blink Contacts Lubricant Eye Drops', 'type': 'DEVICE', 'description': 'Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.', 'armGroupLabels': ['AMO Blink Contacts Lubricant Eye Drops']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Bausch & Lomb', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Stephanie Su, OD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bausch & Lomb Incorporated'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}