Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-03-07 @ 4:04 PM
Study NCT ID:
NCT02702518
Status:
TERMINATED
Last Update Posted:
2021-09-05
First Post:
2016-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
rhDNase Eye Drops in Patients With Ocular Graft-Vs.-Host Disease
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C568813', 'term': 'dornase alfa'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jains@uic.edu', 'phone': '312-996-4476', 'title': 'Dr. Sandeep Jain', 'organization': 'University of Illinois Chicago'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Between baseline and 8-weeks of treatment', 'eventGroups': [{'id': 'EG000', 'title': 'rhDNase I', 'description': 'rhDNase I 0.1% eye drops 4 times a day for 8 weeks\n\nrhDNase I: rhDNase I, 0.1% eye drops 4 times a day for 8 weeks', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 17, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vehicle', 'description': 'Drug vehicle eye drops 4 times a day for 8 weeks\n\nVehicle: Drug vehicle 4 times a day for 8 weeks', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 10, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Ocular discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blurring of vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Light sensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Foreign body sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Change in the Corneal Surface Staining as Measured by Dye Staining Within Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'rhDNase I', 'description': 'rhDNase I 0.1% eye drops 4 times a day for 8 weeks\n\nrhDNase I: rhDNase I, 0.1% eye drops 4 times a day for 8 weeks'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'Drug vehicle eye drops 4 times a day for 8 weeks\n\nVehicle: Drug vehicle 4 times a day for 8 weeks'}], 'classes': [{'title': 'Week 8', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '2.75', 'upperLimit': '5.00'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '4.00', 'upperLimit': '6.00'}]}]}, {'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.00', 'groupId': 'OG000', 'lowerLimit': '3.00', 'upperLimit': '7.00'}, {'value': '4.00', 'groupId': 'OG001', 'lowerLimit': '3.00', 'upperLimit': '6.00'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'p-values were calculated via linear quantile mixed model for continuous variables with missing data.', 'groupDescription': 'For the outcome measure corneal staining, data at week 8 was compared with data at baseline to determine if a change was significant (threshold p \\< 0.05).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.2324', 'groupIds': ['OG001'], 'pValueComment': 'p-values were calculated via linear quantile mixed model for continuous variables with missing data.', 'groupDescription': 'For the outcome measure corneal staining data at week 8 was compared with data at baseline to determine significant change.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Between baseline and at 8 weeks of treatment', 'description': 'Corneal staining score as measured by dye staining using National Eye Institute (NEI) grading scale. Dye was applied to each eye and a slit lamp was used to observe corneal staining. NEI scale relies on a chart that divides the cornea into 5 sections and assigns a value from 0 (absent) to 3 (severe) to each section, based on the density of punctate staining, final staining score being the sum of individual section scores with a range of 0 (minimum) -15 (maximum) points. Complete corneal staining clearance with dye defined as a score of 0 indicating the best outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Change in Ocular Surface Disease Index (OSDI) Score Within Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'rhDNase I', 'description': 'rhDNase I 0.1% eye drops 4 times a day for 8 weeks\n\nrhDNase I: rhDNase I, 0.1% eye drops 4 times a day for 8 weeks'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'Drug vehicle eye drops 4 times a day for 8 weeks\n\nVehicle: Drug vehicle 4 times a day for 8 weeks'}], 'classes': [{'title': 'Week 8', 'categories': [{'measurements': [{'value': '18.4', 'groupId': 'OG000', 'lowerLimit': '9.16', 'upperLimit': '33.1'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '16.5', 'upperLimit': '44.3'}]}]}, {'title': 'Baseline', 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000', 'lowerLimit': '31.8', 'upperLimit': '50.0'}, {'value': '37.5', 'groupId': 'OG001', 'lowerLimit': '31.8', 'upperLimit': '56.0'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000'], 'pValueComment': 'p-values were calculated via linear quantile mixed model for continuous variables.', 'groupDescription': 'For the outcome measure OSDI, data at week 8 was compared with data at baseline to determine if a change was significant (threshold p \\< 0.05).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.2257', 'groupIds': ['OG001'], 'pValueComment': 'p-values were calculated via linear quantile mixed model for continuous variables.', 'groupDescription': 'For the outcome measure OSDI data at week 8 was compared with data at baseline to determine significant change.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Between baseline and at 8 weeks of treatment', 'description': 'Ocular Surface Disease Index (OSDI), a 12-item questionnaire, assesses symptom of ocular irritation in dry eye disease (DED) and how it affects functioning related to vision in the past week. It has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on 0 to 4 scale with 0 being "none of the time" and 4 being "all of the time." OSDI score range from 0-100 with score 0-12 being normal, 13-22 being mild DED, 23-32 being moderate DED, and \\>33 being severe DED. OSDI=\\[(sum of scores for questions answered)×100\\]/\\[(total questions answered)×4\\]', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'rhDNase I', 'description': 'rhDNase I 0.1% eye drops 4 times a day for 8 weeks\n\nrhDNase I: rhDNase I, 0.1% eye drops 4 times a day for 8 weeks'}, {'id': 'FG001', 'title': 'Vehicle', 'description': 'Drug vehicle eye drops 4 times a day for 8 weeks\n\nVehicle: Drug vehicle 4 times a day for 8 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'rhDNase I', 'description': 'rhDNase I 0.1% eye drops 4 times a day for 8 weeks\n\nrhDNase I: rhDNase I, 0.1% eye drops 4 times a day for 8 weeks'}, {'id': 'BG001', 'title': 'Vehicle', 'description': 'Drug vehicle eye drops 4 times a day for 8 weeks\n\nVehicle: Drug vehicle 4 times a day for 8 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000', 'lowerLimit': '46', 'upperLimit': '60'}, {'value': '52', 'groupId': 'BG001', 'lowerLimit': '44', 'upperLimit': '60'}, {'value': '53', 'groupId': 'BG002', 'lowerLimit': '44', 'upperLimit': '60'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Indication (%)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Leukemia', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Lymphoma', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Multiple myeloma', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Myeloproliferative disorders', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMT date (years)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'BG000', 'lowerLimit': '1.9', 'upperLimit': '9.5'}, {'value': '2.2', 'groupId': 'BG001', 'lowerLimit': '1.2', 'upperLimit': '3.6'}, {'value': '2.8', 'groupId': 'BG002', 'lowerLimit': '1.3', 'upperLimit': '6.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Heart rate', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000', 'lowerLimit': '69.8', 'upperLimit': '88.2'}, {'value': '81', 'groupId': 'BG001', 'lowerLimit': '73', 'upperLimit': '88'}, {'value': '83.5', 'groupId': 'BG002', 'lowerLimit': '70.25', 'upperLimit': '88'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Beats per minute (BPM)', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Temperature', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '97.8', 'groupId': 'BG000', 'lowerLimit': '97.4', 'upperLimit': '98'}, {'value': '97.6', 'groupId': 'BG001', 'lowerLimit': '96.9', 'upperLimit': '98'}, {'value': '97.7', 'groupId': 'BG002', 'lowerLimit': '97.13', 'upperLimit': '98'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'degrees Fahrenheit', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Systemic GVHD', 'classes': [{'title': 'Skin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'GI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Mouth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'Lung', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Genitalia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'populationDescription': 'These counts only correspond to subjects with systemic GVHD. Some subjects had more than one presentation of systemic GVHD.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-26', 'size': 1862056, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-06-09T15:49', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'whyStopped': 'The DSMB committee recommended closing the trial because of the COVID-19 risk in this "at-risk" oGVHD population if they came for study visits.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-10', 'studyFirstSubmitDate': '2016-03-03', 'resultsFirstSubmitDate': '2021-06-10', 'studyFirstSubmitQcDate': '2016-03-03', 'lastUpdatePostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-16', 'studyFirstPostDateStruct': {'date': '2016-03-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Change in the Corneal Surface Staining as Measured by Dye Staining Within Groups.', 'timeFrame': 'Between baseline and at 8 weeks of treatment', 'description': 'Corneal staining score as measured by dye staining using National Eye Institute (NEI) grading scale. Dye was applied to each eye and a slit lamp was used to observe corneal staining. NEI scale relies on a chart that divides the cornea into 5 sections and assigns a value from 0 (absent) to 3 (severe) to each section, based on the density of punctate staining, final staining score being the sum of individual section scores with a range of 0 (minimum) -15 (maximum) points. Complete corneal staining clearance with dye defined as a score of 0 indicating the best outcome.'}], 'secondaryOutcomes': [{'measure': 'The Change in Ocular Surface Disease Index (OSDI) Score Within Groups', 'timeFrame': 'Between baseline and at 8 weeks of treatment', 'description': 'Ocular Surface Disease Index (OSDI), a 12-item questionnaire, assesses symptom of ocular irritation in dry eye disease (DED) and how it affects functioning related to vision in the past week. It has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on 0 to 4 scale with 0 being "none of the time" and 4 being "all of the time." OSDI score range from 0-100 with score 0-12 being normal, 13-22 being mild DED, 23-32 being moderate DED, and \\>33 being severe DED. OSDI=\\[(sum of scores for questions answered)×100\\]/\\[(total questions answered)×4\\]'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['rhDNase I, Pulmozyme, oGVHD, Dry Eye'], 'conditions': ['Ocular Graft vs Host Disease', 'Dry Eye']}, 'referencesModule': {'references': [{'pmid': '24255046', 'type': 'RESULT', 'citation': 'Tibrewal S, Sarkar J, Jassim SH, Gandhi S, Sonawane S, Chaudhary S, Byun YS, Ivanir Y, Hallak J, Horner JH, Newcomb M, Jain S. Tear fluid extracellular DNA: diagnostic and therapeutic implications in dry eye disease. Invest Ophthalmol Vis Sci. 2013 Dec 11;54(13):8051-61. doi: 10.1167/iovs.13-12844.'}, {'pmid': '23169882', 'type': 'RESULT', 'citation': 'Sonawane S, Khanolkar V, Namavari A, Chaudhary S, Gandhi S, Tibrewal S, Jassim SH, Shaheen B, Hallak J, Horner JH, Newcomb M, Sarkar J, Jain S. Ocular surface extracellular DNA and nuclease activity imbalance: a new paradigm for inflammation in dry eye disease. Invest Ophthalmol Vis Sci. 2012 Dec 17;53(13):8253-63. doi: 10.1167/iovs.12-10430.'}, {'pmid': '38407974', 'type': 'DERIVED', 'citation': 'Mun CS, Surenkhuu B, Chen YF, Atassi N, Mun J, Kim C, Sheth T, Sarwar MA, Pradeep A, Jain S. Recombinant Deoxyribonuclease I Eye Drops for Ocular Graft Versus Host Disease: Results of a Randomized Clinical Trial. Eye Contact Lens. 2024 May 1;50(5):233-240. doi: 10.1097/ICL.0000000000001078. Epub 2024 Feb 23.'}], 'seeAlsoLinks': [{'url': 'https://hospital.uillinois.edu/find-a-doctor/sandeep-jain', 'label': 'Principal Investigator description'}, {'url': 'http://cornealneurobiology.uic.edu/', 'label': 'Description of research laboratory'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the tolerability and preliminary efficacy of rhDNase I eye drops in patients with ocular Graft-vs.-Host disease (oGVHD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The PI and other members of International Chronic Ocular GVHD Consensus Group have established the consensus diagnostic criteria and classification for chronic ocular GVHD.\n\nTable 1: Severity scale in chronic ocular GVHD\n\nSeverity scores (points) Schirmer's test (mm) CFS (points) OSDI (points) Conj (points) 0 \\>15 0 \\<13 None\n\n1. 11-15 \\<2 13-22 Mild/Moderate\n2. 6-10 2-3 23-32 Severe\n3. ≤5 ≥4 ≥33\n\nCFS; corneal fluorescein staining, OSDI; Ocular Surface Disease Index. Conj; conjunctival injection. Severity classification; Total score (points); (Schirmer's test score+ CFS score+ OSDI score+ Conj injection score) = None;0-4, Mild/Moderate; 5-8, Severe, 9-11.\n\nTable 2: Diagnosis of chronic ocular GVHD None (points) Probable GVHD (points) Definite GVHD (points) Systemic GVHD(-) 0-5 6-7 ≥8 Systemic GVHD(+) 0-3 4-5 ≥6\n\nBased on these criteria (Tables 1 and 2),40 patients with definite ocular GVHD will be enrolled. Additionally, all of the following criteria should be met to be eligible for the study:\n\n* Aged 18 years or older.\n* Capable of giving informed consent and does provide informed consent.\n* Schirmer I \\<10\n* Corneal/ conjunctival (Rose Bengal) staining ≥1\n* Ocular symptoms must be considered as annoying or activity limiting (OSDI ≥13; mild).\n* Women must be post-menopausal ≥ 1 year, or surgically sterilized. If not, a negative urine pregnancy test is required within 14 days of receiving her first dose of test medication (placebo/ study drug) along with definite evidence of contraceptive use during the duration of the study. Women of reproductive age should use a method of birth control that is acceptable to the subject and the study doctor. This may include oral contraceptive pills, birth control implants, barrier methods or abstinence. If a subject mentions she suspects she may be pregnant after being enrolled, another pregnancy test will be administered. If the test is positive, she will be discontinued from the study immediately.\n\nExclusion Criteria:\n\n* Subjects will not be eligible for the study if any of the following criteria are met:\n\n * Allergic to rhDNase I or any similar products, or recipient of rhDNase I eye drops 0.1%.\n * Receiving or have received within 30 days any experimental systemic medication.\n * Active ocular infection or ocular allergies.\n * Any history of eyelid surgery or ocular surgery within the past 3 months.\n * Corneal epithelial defect larger than 1 mm2 in either eye.\n * Have active drug/alcohol dependence or abuse history.\n * Vulnerable populations, such as neonates, pregnant women, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations."}, 'identificationModule': {'nctId': 'NCT02702518', 'briefTitle': 'rhDNase Eye Drops in Patients With Ocular Graft-Vs.-Host Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'A Phase I/II Randomized Placebo-Controlled, Double-Blind, Single-Center, Tolerability and Preliminary Efficacy Clinical Trial of Recombinant Human Deoxyribonuclease (rhDNase) Eye Drops in Patients With Ocular Graft-Vs.-Host Disease', 'orgStudyIdInfo': {'id': '2014-0372'}, 'secondaryIdInfos': [{'id': 'R01EY024966-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R01EY024966-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'rhDNase I', 'description': 'rhDNase I 0.1% eye drops 4 times a day for 8 weeks', 'interventionNames': ['Drug: rhDNase I']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': 'Drug vehicle eye drops 4 times a day for 8 weeks', 'interventionNames': ['Drug: Vehicle']}], 'interventions': [{'name': 'rhDNase I', 'type': 'DRUG', 'otherNames': ['Pulmozyme'], 'description': 'rhDNase I, 0.1% eye drops 4 times a day for 8 weeks', 'armGroupLabels': ['rhDNase I']}, {'name': 'Vehicle', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Drug vehicle 4 times a day for 8 weeks', 'armGroupLabels': ['Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Translational Clinic of Corneal Neurobiology laboratory, Illinois Eye and Ear Infirmary, University of Illinois at Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois Eye and Ear Infirmary', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Sandeep Jain, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Chicago'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, {'name': 'National Eye Institute (NEI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Ophthalmology', 'investigatorFullName': 'Sandeep Jain, MD', 'investigatorAffiliation': 'University of Illinois at Chicago'}}}}