Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2026-01-03 @ 9:42 PM
Study NCT ID:
NCT02643095
Status:
COMPLETED
Last Update Posted:
2023-12-06
First Post:
2015-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of Scleral Contact Lenses for Daily Wear for Regular and Irregular Refractive Errors Compared to Habitually Worn Scleral Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Fogt.78@osu.edu', 'phone': '614-292-2020', 'title': 'Jennifer Fogt', 'organization': 'The Ohio State University College of Optometry'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected at all study visits, including a visit after 1 week and 1 month of lens wear.', 'eventGroups': [{'id': 'EG000', 'title': 'Lens Fitting/Evaluation', 'description': 'This study was conducted with subjects who already habitually wear scleral contact lenses. The study lens is made with a material that is already widely available and has a new design. It was fit by the investigators and assessed and at one week and 1 month.\n\nscleral contact lens: Scleral contact lens', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 1, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'punctate keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Primary Endpoint of the Study is the Overall Satisfaction and Desire to Continue Wearing the Study Lenses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lens Fitting/Evaluation', 'description': 'This study was conducted with subjects who already habitually wear scleral contact lenses. The study lens is made with a material that is already widely available and has a new design. It was fit by the investigators and assessed and at one week and 1 month.\n\nscleral contact lens: Scleral contact lens'}], 'classes': [{'categories': [{'title': 'Preferred test lenses to habitual lenses', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Preferred habitual lenses to test lenses', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'No preference', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 month after lens is dispensed', 'description': 'Number of Participants with Overall Satisfaction and Desire to Continue Wearing the Study Lenses', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lens Fitting/Evaluation', 'description': 'This study was conducted with subjects who already habitually wore scleral contact lenses. The study lens was made with a material that is already widely available and has a new design. It was fit by the investigators and assessed one week and 1 month of wear.\n\nscleral contact lens: Scleral contact lens'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Lens Fitting/Evaluation', 'description': 'This study was conducted with subjects who already habitually wear scleral contact lenses. The study lens is made with a material that is already widely available and has a new design. It was fit by the investigators and assessed and at one week and 1 month.\n\nscleral contact lens: Scleral contact lens'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age 18 or older', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2016-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-13', 'studyFirstSubmitDate': '2015-12-28', 'resultsFirstSubmitDate': '2018-08-17', 'studyFirstSubmitQcDate': '2015-12-28', 'lastUpdatePostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-17', 'studyFirstPostDateStruct': {'date': '2015-12-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Primary Endpoint of the Study is the Overall Satisfaction and Desire to Continue Wearing the Study Lenses', 'timeFrame': '1 month after lens is dispensed', 'description': 'Number of Participants with Overall Satisfaction and Desire to Continue Wearing the Study Lenses'}]}, 'conditionsModule': {'conditions': ['Scleral Lens Wearers']}, 'descriptionModule': {'briefSummary': 'This study will be done with subjects who already habitually wear scleral contact lenses. The study lens is made with a material that is already widely available and has a new design. It will be fit by the investigators and will be assessed and at one week and 1 month.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects may be male or female, of any race, and at least 18 years old at the time of the pre-treatment examination.\n2. Subjects must habitually wear scleral contact lenses for an average wearing time of 6 hours per day.\n3. The prospective eye(s) must have refractive hyperopia or myopia from +20.00 to -20.00 diopters sphere (spectacle plane), with up to -10.00 diopters of refractive astigmatism (spectacle plane), as determined by manifest refraction (phoropter or trial frame with a 12.5 mm vertex distance).\n4. Subjects must have best spectacle corrected visual acuity of at least 0.5 logMAR in each eye.\n5. Subjects must be willing and capable to return for all scheduled follow-up visits for a period of at least 3 months (minimum of 1 month from initial dispensing).\n\nExclusion Criteria:\n\n1. Female subjects who are pregnant, breast-feeding or intend to become pregnant over the course of the study.\n2. Subjects with a history of any of the following medical conditions: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to active thyroid disorders and diabetes), lupus, and rheumatoid arthritis.\n\n Note: The presence of diabetes (either type 1 or 2), regardless of disease duration, severity or control, will specifically exclude subjects from eligibility.\n3. Subjects with active ophthalmic disease or abnormality including glaucoma, chorioretinitis, central retinal artery or vein occlusion, intraocular or ocular infection.\n4. Subjects who are participating in any other clinical trial (FDA or other)'}, 'identificationModule': {'nctId': 'NCT02643095', 'briefTitle': 'Efficacy of Scleral Contact Lenses for Daily Wear for Regular and Irregular Refractive Errors Compared to Habitually Worn Scleral Lenses', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'orgStudyIdInfo': {'id': '2015W0197'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lens fitting/evaluation', 'description': 'This study will be done with subjects who already habitually wear scleral contact lenses. The study lens is made with a material that is already widely available and has a new design. It will be fit by the investigators and will be assessed and at one week and 1 month.', 'interventionNames': ['Device: scleral contact lens']}], 'interventions': [{'name': 'scleral contact lens', 'type': 'DEVICE', 'description': 'Scleral contact lens', 'armGroupLabels': ['Lens fitting/evaluation']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jennifer Fogt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jennifer Fogt', 'investigatorAffiliation': 'Ohio State University'}}}}