Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-01 @ 2:53 PM
Study NCT ID:
NCT03029104
Status:
TERMINATED
Last Update Posted:
2022-01-12
First Post:
2017-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Collagen Cross-Linking With Ultraviolet-A in Asymmetric Corneas
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007640', 'term': 'Keratoconus'}, {'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@cxlophthalmics.com', 'phone': '339-234-6020', 'title': 'Chief Clinical Development Officer', 'organization': 'CXL Ophthalmics, LLC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 months', 'description': 'A total of 2,228 subjects were randomized and treated in this study (Treated Analysis Set). 1,583 (71%) of these subjects received bilateral, simultaneous treatments. The Safety Analysis Set (SAS) is larger than the Treated Analysis Set because subjects who had an initial unilateral treatment and then had a subsequent procedure, appear in the SAS under two different treatment groups, if the subsequent treatment differs from the initial treatment. This occurred in 19 subjects.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1', 'description': 'Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.\n\nCXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution', 'otherNumAtRisk': 750, 'deathsNumAtRisk': 750, 'otherNumAffected': 0, 'seriousNumAtRisk': 750, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2', 'description': 'Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 6 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.\n\nCXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution', 'otherNumAtRisk': 745, 'deathsNumAtRisk': 745, 'otherNumAffected': 0, 'seriousNumAtRisk': 745, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group 3', 'description': 'Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 30 minutes.\n\nCXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution', 'otherNumAtRisk': 752, 'deathsNumAtRisk': 752, 'otherNumAffected': 0, 'seriousNumAtRisk': 752, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Diverticulitis', 'notes': 'Subject developed diverticulitis 208 days post-procedure; not related; treated and resolved.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 750, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 752, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Corrected Distance Visual Acuity (CDVA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '542', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}, {'value': '529', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.\n\nCXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 6 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.\n\nCXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution'}, {'id': 'OG002', 'title': 'Group 3', 'description': 'Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 30 minutes.\n\nCXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution'}], 'classes': [{'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '472', 'groupId': 'OG000'}, {'value': '461', 'groupId': 'OG001'}, {'value': '467', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.058', 'spread': '0.0088', 'groupId': 'OG000'}, {'value': '-0.068', 'spread': '0.0094', 'groupId': 'OG001'}, {'value': '-0.064', 'spread': '0.0104', 'groupId': 'OG002'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.074', 'spread': '0.0119', 'groupId': 'OG000'}, {'value': '-0.060', 'spread': '0.0127', 'groupId': 'OG001'}, {'value': '-0.071', 'spread': '0.0176', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 and 12 months', 'description': 'Changes in CDVA are reported as the value at 6 and 12 months minus the value at baseline', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Keratoconus subjects completing assessment'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Uncorrected Distance Visual Acuity (UCVA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '541', 'groupId': 'OG000'}, {'value': '533', 'groupId': 'OG001'}, {'value': '528', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.\n\nCXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 6 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.\n\nCXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution'}, {'id': 'OG002', 'title': 'Group 3', 'description': 'Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 30 minutes.\n\nCXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution'}], 'classes': [{'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '469', 'groupId': 'OG000'}, {'value': '461', 'groupId': 'OG001'}, {'value': '468', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.0853', 'spread': '0.0150', 'groupId': 'OG000'}, {'value': '-0.1099', 'spread': '0.0150', 'groupId': 'OG001'}, {'value': '-0.0990', 'spread': '0.0155', 'groupId': 'OG002'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}, {'value': '272', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.0875', 'spread': '0.0191', 'groupId': 'OG000'}, {'value': '-0.0696', 'spread': '0.0197', 'groupId': 'OG001'}, {'value': '-0.1243', 'spread': '0.0212', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 and 12 months', 'description': 'Changes in UCVA are reported as the value at 6 and 12 months minus the value at baseline', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Keratoconus subjects completing assessment'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Maximum Keratometry (KMax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '542', 'groupId': 'OG000'}, {'value': '533', 'groupId': 'OG001'}, {'value': '527', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.\n\nCXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 6 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.\n\nCXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution'}, {'id': 'OG002', 'title': 'Group 3', 'description': 'Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 30 minutes.\n\nCXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution'}], 'classes': [{'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '471', 'groupId': 'OG000'}, {'value': '460', 'groupId': 'OG001'}, {'value': '465', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.1979', 'spread': '0.1069', 'groupId': 'OG000'}, {'value': '-0.4033', 'spread': '0.1228', 'groupId': 'OG001'}, {'value': '-0.3673', 'spread': '0.1125', 'groupId': 'OG002'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '270', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.2859', 'spread': '0.1204', 'groupId': 'OG000'}, {'value': '-0.5268', 'spread': '0.1716', 'groupId': 'OG001'}, {'value': '-0.5256', 'spread': '0.1707', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 and 12 months', 'description': 'Kmax is the maximum value of corneal curvature in Diopters. Changes in Kmax are reported as the value at 6 and 12 months minus the value at baseline.', 'unitOfMeasure': 'Diopters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Keratoconus subjects completing assessment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1', 'description': 'Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.\n\nCXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution'}, {'id': 'FG001', 'title': 'Group 2', 'description': 'Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 6 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.\n\nCXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening 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[{'units': 'Participants', 'counts': [{'value': '745', 'groupId': 'BG000'}, {'value': '735', 'groupId': 'BG001'}, {'value': '748', 'groupId': 'BG002'}, {'value': '2228', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1', 'description': 'Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.\n\nCXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution'}, {'id': 'BG001', 'title': 'Group 2', 'description': 'Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 6 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.\n\nCXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution'}, {'id': 'BG002', 'title': 'Group 3', 'description': 'Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 30 minutes.\n\nCXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.6', 'spread': '13.04', 'groupId': 'BG000'}, {'value': '32.4', 'spread': '13.11', 'groupId': 'BG001'}, {'value': '32.6', 'spread': '12.94', 'groupId': 'BG002'}, {'value': '32.5', 'spread': '13.03', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '≤21 years', 'categories': [{'measurements': [{'value': '175', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}, {'value': '513', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '221', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}, {'value': '658', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '524', 'groupId': 'BG000'}, {'value': '518', 'groupId': 'BG001'}, {'value': '528', 'groupId': 'BG002'}, {'value': '1570', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}, {'value': '398', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '603', 'groupId': 'BG000'}, {'value': '617', 'groupId': 'BG001'}, {'value': '609', 'groupId': 'BG002'}, {'value': '1829', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '101', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '280', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '582', 'groupId': 'BG000'}, {'value': '573', 'groupId': 'BG001'}, {'value': '584', 'groupId': 'BG002'}, {'value': '1739', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '745', 'groupId': 'BG000'}, {'value': '735', 'groupId': 'BG001'}, {'value': '748', 'groupId': 'BG002'}, {'value': '2228', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Diagnosis of Keratoconus', 'classes': [{'categories': [{'measurements': [{'value': '644', 'groupId': 'BG000'}, {'value': '635', 'groupId': 'BG001'}, {'value': '643', 'groupId': 'BG002'}, {'value': '1922', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-05', 'size': 5809395, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-11-14T18:33', 'hasProtocol': True}, {'date': '2018-07-26', 'size': 307368, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-11-14T16:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Visual acuity will be evaluated by an observer who is masked as to the treatment protocol to which study subjects have been assigned.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2228}}, 'statusModule': {'whyStopped': 'Sufficient clinical results obtained to support study endpoints.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2020-12-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-15', 'studyFirstSubmitDate': '2017-01-20', 'resultsFirstSubmitDate': '2021-11-14', 'studyFirstSubmitQcDate': '2017-01-20', 'lastUpdatePostDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-15', 'studyFirstPostDateStruct': {'date': '2017-01-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Corrected Distance Visual Acuity (CDVA)', 'timeFrame': 'Baseline and 6 and 12 months', 'description': 'Changes in CDVA are reported as the value at 6 and 12 months minus the value at baseline'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Uncorrected Distance Visual Acuity (UCVA)', 'timeFrame': 'Baseline and 6 and 12 months', 'description': 'Changes in UCVA are reported as the value at 6 and 12 months minus the value at baseline'}, {'measure': 'Change From Baseline in Maximum Keratometry (KMax)', 'timeFrame': 'Baseline and 6 and 12 months', 'description': 'Kmax is the maximum value of corneal curvature in Diopters. Changes in Kmax are reported as the value at 6 and 12 months minus the value at baseline.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Keratoconus', 'Forme fruste keratoconus', 'Post-LASIK ectasia', 'Pellucid marginal degeneration', 'Forme fruste pellucid marginal degeneration', 'Diurnal fluctuation post-radial keratotomy', "Terrien's marginal degeneration"], 'conditions': ['Keratoconus', 'Corneal Diseases', 'Eye Diseases', 'Photosensitizing Agents']}, 'referencesModule': {'references': [{'pmid': '36173242', 'type': 'DERIVED', 'citation': 'Epstein RJ, Belin MW, Gravemann D, Littner R, Rubinfeld RS. EpiSmart Crosslinking for Keratoconus: A Phase 2 Study. Cornea. 2023 Jul 1;42(7):858-866. doi: 10.1097/ICO.0000000000003136. Epub 2022 Sep 28.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess changes in visual acuity and corneal symmetry after corneal collagen cross-linking (CXL) of asymmetric corneas.', 'detailedDescription': "This study will evaluate the results of Corneal Collagen Crosslinking (CXL) in patients with conditions that include keratoconus, forme fruste keratoconus, post-LASIK ectasia, pellucid marginal degeneration, forme fruste pellucid marginal degeneration, diurnal fluctuation post-radial keratotomy, or Terrien's marginal degeneration. This is an outcomes study, all patients receive treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A diagnosis of at least one of the following conditions:\n\n 1. Keratoconus\n 2. Forme fruste keratoconus\n 3. Post-LASIK ectasia\n 4. Pellucid marginal degeneration\n 5. Forme fruste pellucid marginal degeneration\n 6. Diurnal fluctuation post-radial keratotomy\n 7. Terrien's marginal degeneration\n\nExclusion Criteria:\n\n1. Corneal thickness \\< 375 microns measured by ultrasound or Pentacam.\n2. Contraindications or hypersensitivities to any study medications or their components.\n3. Pregnancy or breastfeeding.\n4. Any history of herpes simplex corneal disease in an eye to be treated.\n5. Nystagmus or any other condition that would, in the judgement of the investigator, prevent a steady gaze during the treatment.\n6. Inability to cooperate with diagnostic tests.\n7. Enrollment in another ophthalmic clinical trial."}, 'identificationModule': {'nctId': 'NCT03029104', 'briefTitle': 'Collagen Cross-Linking With Ultraviolet-A in Asymmetric Corneas', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cxlusa'}, 'officialTitle': 'Collagen Cross-Linking With Ultraviolet-A in Asymmetric Corneas', 'orgStudyIdInfo': {'id': 'CXL-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.', 'interventionNames': ['Combination Product: CXLO Corneal Strengthening Solution and UVA Illumination Device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 6 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.', 'interventionNames': ['Combination Product: CXLO Corneal Strengthening Solution and UVA Illumination Device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3', 'description': 'Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 30 minutes.', 'interventionNames': ['Combination Product: CXLO Corneal Strengthening Solution and UVA Illumination Device']}], 'interventions': [{'name': 'CXLO Corneal Strengthening Solution and UVA Illumination Device', 'type': 'COMBINATION_PRODUCT', 'description': 'CXLO Corneal Strengthening Solution', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85260', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Schwartz Laser Eye Center', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Goodman Eye Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80120-4508', 'city': 'Littleton', 'state': 'Colorado', 'country': 'United States', 'facility': 'Cornea Consultants of Colorado', 'geoPoint': {'lat': 39.61332, 'lon': -105.01665}}, {'zip': '30328', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Woolfson Eye Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60035', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Chicago Cornea Consultants', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60169', 'city': 'Hoffman Estates', 'state': 'Illinois', 'country': 'United States', 'facility': 'Chicago Cornea Consultants, Ltd.', 'geoPoint': {'lat': 42.04281, 'lon': -88.0798}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Ophthalmology Associates', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '44141', 'city': 'Brecksville', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Eye Clinic', 'geoPoint': {'lat': 41.31978, 'lon': -81.62679}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Cornea Associates of Texas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Gregg J Berdy, MD, FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ophthalmology Associates, St. Louis, MO'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cxlusa', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}