Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-26 @ 6:59 PM
Study NCT ID:
NCT00324168
Status:
COMPLETED
Last Update Posted:
2018-08-01
First Post:
2006-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Steroids for Corneal Ulcers Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003320', 'term': 'Corneal Ulcer'}, {'id': 'D015818', 'term': 'Eye Infections, Bacterial'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D005128', 'term': 'Eye Diseases'}], 'ancestors': [{'id': 'D015817', 'term': 'Eye Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007634', 'term': 'Keratitis'}, {'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000900', 'term': 'Anti-Bacterial Agents'}, {'id': 'D000077266', 'term': 'Moxifloxacin'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}], 'ancestors': [{'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tom.lietman@ucsf.edu', 'phone': '415-502-2662', 'title': 'Dr. Thomas Lietman', 'organization': 'F.I. Proctor Foundation, University of Califonia, San Francisco'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 months from enrollment', 'eventGroups': [{'id': 'EG000', 'title': 'Steroid', 'description': 'Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week\n\nAntibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization', 'otherNumAtRisk': 250, 'otherNumAffected': 44, 'seriousNumAtRisk': 250, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week\n\nAntibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization', 'otherNumAtRisk': 250, 'otherNumAffected': 34, 'seriousNumAtRisk': 250, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Increase in hypopyon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 250, 'numAffected': 4}], 'organSystem': 'Eye disorders'}, {'term': 'Increase in infiltrate size >50%', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 250, 'numAffected': 4}], 'organSystem': 'Eye disorders'}, {'term': 'No healing of epithelial defect by 21 days', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 250, 'numAffected': 27}], 'organSystem': 'Eye disorders'}, {'term': 'Intraocular pressure (IOP) elevated >25mm Hg by <35 mm Hg', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 250, 'numAffected': 10}], 'organSystem': 'Eye disorders'}, {'term': 'Progressive corneal thinning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numAffected': 2}], 'organSystem': 'Eye disorders'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 250, 'numAffected': 13}], 'organSystem': 'General disorders'}], 'seriousEvents': [{'term': 'Corneal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 250, 'numAffected': 8}], 'organSystem': 'Eye disorders'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 250, 'numAffected': 5}], 'organSystem': 'General disorders'}, {'term': 'Systemic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Best Spectacle-corrected Visual Acuity (BSCVA) in logMAR at 3 Months, Using Best Spectacle-corrected Enrollment Visual Acuity as a Co-variate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Steroid', 'description': 'Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week\n\nAntibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week\n\nAntibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization'}], 'classes': [{'categories': [{'measurements': [{'value': '0.48', 'groupId': 'OG000', 'lowerLimit': '0.42', 'upperLimit': '0.53'}, {'value': '0.49', 'groupId': 'OG001', 'lowerLimit': '0.43', 'upperLimit': '0.54'}]}]}], 'analyses': [{'pValue': '0.82', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.009', 'ciLowerLimit': '-0.085', 'ciUpperLimit': '0.068', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for enrollment BSCVA'}], 'paramType': 'MEAN', 'timeFrame': '3 months from enrollment', 'description': 'LogMAR (logarithm of the Minimum Angle of Resolution) is a measure of visual acuity in which the smaller values indicate better visual acuity.', 'unitOfMeasure': 'logMAR', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Infiltrate/Scar Size, Correcting for Infiltrate/Scar Size at Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Steroid', 'description': 'Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week\n\nAntibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week\n\nAntibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization'}], 'classes': [{'categories': [{'measurements': [{'value': '3.07', 'groupId': 'OG000', 'lowerLimit': '2.99', 'upperLimit': '3.16'}, {'value': '3.02', 'groupId': 'OG001', 'lowerLimit': '2.93', 'upperLimit': '3.11'}]}]}], 'analyses': [{'pValue': '0.40', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.15', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '3 months from enrollment', 'unitOfMeasure': 'mm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Best Hard Contact Lens Corrected Visual Acuity Measured in logMAR, Correcting for Best Spectacle Corrected Visual Acuity at Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Steroid', 'description': 'Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week\n\nAntibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week\n\nAntibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization'}], 'classes': [{'categories': [{'measurements': [{'value': '0.42', 'groupId': 'OG000', 'lowerLimit': '0.36', 'upperLimit': '0.47'}, {'value': '0.41', 'groupId': 'OG001', 'lowerLimit': '0.36', 'upperLimit': '0.46'}]}]}], 'analyses': [{'pValue': '0.873', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.08', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '3 months from enrollment', 'description': 'LogMAR (logarithm of the Minimum Angle of Resolution) is a measure of visual acuity in which the smaller values indicate better visual acuity.', 'unitOfMeasure': 'logMAR', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Resolution of Epithelial Defect', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Steroid', 'description': 'Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week\n\nAntibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week\n\nAntibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization'}], 'classes': [{'categories': [{'measurements': [{'value': '9.77', 'spread': '7.54', 'groupId': 'OG000', 'lowerLimit': '7.54'}, {'value': '9.43', 'spread': '7.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.44', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.12', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'From enrollment up to 21 days', 'description': 'This outcome measured time from enrollment to resolution of the epithelial defect in days for up to 21 days. For three weeks patients were examined every 3 days for size of epithelial defect until the defect was gone.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ocular Perforations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Steroid', 'description': 'Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week\n\nAntibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week\n\nAntibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.99', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'At the time of perforation', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Best Spectacle-corrected Visual Acuity (BSCVA) in logMAR at 12 Months, Using Best Spectacle-corrected Enrollment Visual Acuity as a Co-variate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Steroid', 'description': 'Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week\n\nAntibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week\n\nAntibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization'}], 'classes': [{'categories': [{'measurements': [{'value': '2.90', 'groupId': 'OG000', 'lowerLimit': '2.80', 'upperLimit': '3.01'}, {'value': '2.87', 'groupId': 'OG001', 'lowerLimit': '2.77', 'upperLimit': '2.98'}]}]}], 'analyses': [{'pValue': '0.39', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.05', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '12 months from enrollment', 'description': 'LogMAR (logarithm of the Minimum Angle of Resolution) is a measure of visual acuity in which the smaller values indicate better visual acuity.', 'unitOfMeasure': 'logMAR', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Best Spectacle-corrected Visual Acuity (BSCVA) in logMAR Using MIC (Minimum Inhibitory Concentration) to Moxifloxacin as a Covariate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Steroid', 'description': 'Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week\n\nAntibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week\n\nAntibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization'}], 'classes': [{'categories': [{'measurements': [{'value': '0.50', 'spread': '0.58', 'groupId': 'OG000', 'lowerLimit': '0.44', 'upperLimit': '0.56'}, {'value': '0.46', 'spread': '0.49', 'groupId': 'OG001', 'lowerLimit': '0.40', 'upperLimit': '0.52'}]}]}], 'analyses': [{'pValue': '0.78', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.04', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '3 months after enrollment', 'description': 'Best spectacle-corrected visual acuity (BSCVA) for this outcome is measured in logMAR (logarithm of the Minimum Angle of Resolution) in which smaller values indicate better visual acuity. Minimum inhibitory concentration (MIC) to moxifloxacin was measured by E test and a log2-transformation of MIC was used in all analyses. In this analysis we add MIC to the model examining BSCVA at 3 months.', 'unitOfMeasure': 'logMAR', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The study population analyzed for this outcome includes only those study subjects for whom an MIC value was available.'}, {'type': 'SECONDARY', 'title': 'Subgroup Analysis Predicting 3 Month Best Spectacle-corrected Visual Acuity (BSCVA) by Causative Organism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Steroid', 'description': 'Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week\n\nAntibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week\n\nAntibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization'}], 'classes': [{'title': 'Nocardia spp', 'categories': [{'measurements': [{'value': '0.54', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '0.36', 'spread': '0.64', 'groupId': 'OG001'}]}]}, {'title': 'Streptococcus pneumoniae', 'categories': [{'measurements': [{'value': '0.49', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '0.52', 'spread': '0.53', 'groupId': 'OG001'}]}]}, {'title': 'Moraxella spp', 'categories': [{'measurements': [{'value': '0.46', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '0.26', 'spread': '0.65', 'groupId': 'OG001'}]}]}, {'title': 'Pseudomonas aeruginosa', 'categories': [{'measurements': [{'value': '0.53', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '0.45', 'spread': '0.56', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.30', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-.011', 'ciUpperLimit': '0.35', 'groupDescription': 'Nocardia spp', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.86', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.10', 'groupDescription': 'Streptococcus pneumoniae', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.65', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '0.55', 'groupDescription': 'Moraxella spp', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.67', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.13', 'groupDescription': 'Pseudomonas aeruginosa', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '3 months after enrollment', 'description': 'BSCVA measured in logMAR will be estimated by causative organism (either Nocardia spp, Streptococcus pneumoniae, Moraxella spp, or Pseudomonas aeruginosa). BSCVA will be examined for each causative organism by mean and standard deviation as well as in a regression model.', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subgroup Analysis Predicting 3 Month Best Spectacle-corrected Visual Acuity (BSCVA) by Visual Acuity Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Steroid', 'description': 'Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week\n\nAntibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week\n\nAntibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization'}], 'classes': [{'title': '<20/40', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': '20/40 to 20/800', 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '0.38', 'spread': '0.38', 'groupId': 'OG001'}]}]}, {'title': 'Counting fingers (CF) or worse', 'categories': [{'measurements': [{'value': '1.00', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '1.15', 'spread': '0.61', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.33', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.25', 'groupDescription': '\\<20/40', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.85', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.11', 'groupDescription': '20/40 to 20/800', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.17', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '-0.02', 'groupDescription': 'CF or worse', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '3 months from enrollment', 'description': 'Best spectacle-corrected visual acuity (BSCVA) for this subgroup analysis was measured in logMAR and then categorized by equivalent Snellen fractions', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subgroup Analysis of Best Spectacle-corrected Visual Acuity (BSCVA) by Categories of Infiltrate Depth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Steroid', 'description': 'Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week\n\nAntibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week\n\nAntibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization'}], 'classes': [{'title': '>0-33%', 'categories': [{'measurements': [{'value': '0.35', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '0.26', 'spread': '0.40', 'groupId': 'OG001'}]}]}, {'title': '>33%-67%', 'categories': [{'measurements': [{'value': '0.52', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '0.47', 'spread': '0.54', 'groupId': 'OG001'}]}]}, {'title': '>67%-100%', 'categories': [{'measurements': [{'value': '0.80', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '0.86', 'spread': '0.67', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.31', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.17', 'groupDescription': '\\>0-33%', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.94', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.14', 'groupDescription': '\\>33%-67%', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '0.01', 'groupDescription': '\\>67%-100%', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '3 months from enrollment', 'description': 'BSCVA measured in logMAR will be examined by categories infiltrate depth (categorized by depth percentage) by mean and standard deviation as well as in a regression model.', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subgroup Analysis Predicting Best Spectacle-corrected Visual Acuity (BSCVA) as Stratified by Categories of Infiltrate/Scar Size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Steroid', 'description': 'Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week\n\nAntibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week\n\nAntibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization'}], 'classes': [{'title': '0-1.90 mm', 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '0.33', 'groupId': 'OG001'}]}]}, {'title': '1.91-2.70 mm', 'categories': [{'measurements': [{'value': '0.39', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '0.44', 'groupId': 'OG001'}]}]}, {'title': '2.71-4.06 mm', 'categories': [{'measurements': [{'value': '0.53', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '0.53', 'spread': '0.53', 'groupId': 'OG001'}]}]}, {'title': '4.07-8.90 mm', 'categories': [{'measurements': [{'value': '0.85', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '0.96', 'spread': '0.67', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.53', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.20', 'groupDescription': '0-1.90 mm', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.95', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.16', 'groupDescription': '1.91-2.70 mm', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.70', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.18', 'groupDescription': '2.71-4.06 mm', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '0.01', 'groupDescription': '4.07-8.90 mm', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '3 months from enrollment', 'description': 'Best-spectacle visual acuity (BSCVA) at 3 months from enrollment is stratified by categories of infiltrate/scar size and examined by treatment arm', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Steroid', 'description': 'Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, then twice a day for 1 week, and finally once a day for 1 week\n\nAntibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, then twice a day for 1 week, and finally once a day for 1 week\n\nAntibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '250'}, {'groupId': 'FG001', 'numSubjects': '250'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '222'}, {'groupId': 'FG001', 'numSubjects': '220'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Patient did not visit in f/u window', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'Between September 1, 2006 and February 22, 2010, 1,769 patients were screened for the trial and 500 patients were enrolled.', 'preAssignmentDetails': 'Common reasons for ineligibility include impending perforation (n=316, 25%), history of a corneal scar in the affected eye (n=123, 10%) and vision worse than 6/60 in the fellow eye (n=119, 9%).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'BG000'}, {'value': '250', 'groupId': 'BG001'}, {'value': '500', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Steroid', 'description': 'Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week\n\nAntibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week\n\nAntibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '190', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '388', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.0', 'groupId': 'BG000', 'lowerLimit': '40.0', 'upperLimit': '62.0'}, {'value': '54.5', 'groupId': 'BG001', 'lowerLimit': '40.0', 'upperLimit': '61.0'}, {'value': '53.0', 'groupId': 'BG002', 'lowerLimit': '40.0', 'upperLimit': '61.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '273', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '243', 'groupId': 'BG000'}, {'value': '242', 'groupId': 'BG001'}, {'value': '485', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-06', 'studyFirstSubmitDate': '2006-05-05', 'resultsFirstSubmitDate': '2012-11-29', 'studyFirstSubmitQcDate': '2006-05-05', 'lastUpdatePostDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-04-10', 'studyFirstPostDateStruct': {'date': '2006-05-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best Spectacle-corrected Visual Acuity (BSCVA) in logMAR at 3 Months, Using Best Spectacle-corrected Enrollment Visual Acuity as a Co-variate', 'timeFrame': '3 months from enrollment', 'description': 'LogMAR (logarithm of the Minimum Angle of Resolution) is a measure of visual acuity in which the smaller values indicate better visual acuity.'}], 'secondaryOutcomes': [{'measure': 'Infiltrate/Scar Size, Correcting for Infiltrate/Scar Size at Enrollment', 'timeFrame': '3 months from enrollment'}, {'measure': 'Best Hard Contact Lens Corrected Visual Acuity Measured in logMAR, Correcting for Best Spectacle Corrected Visual Acuity at Enrollment', 'timeFrame': '3 months from enrollment', 'description': 'LogMAR (logarithm of the Minimum Angle of Resolution) is a measure of visual acuity in which the smaller values indicate better visual acuity.'}, {'measure': 'Time to Resolution of Epithelial Defect', 'timeFrame': 'From enrollment up to 21 days', 'description': 'This outcome measured time from enrollment to resolution of the epithelial defect in days for up to 21 days. For three weeks patients were examined every 3 days for size of epithelial defect until the defect was gone.'}, {'measure': 'Ocular Perforations', 'timeFrame': 'At the time of perforation'}, {'measure': 'Best Spectacle-corrected Visual Acuity (BSCVA) in logMAR at 12 Months, Using Best Spectacle-corrected Enrollment Visual Acuity as a Co-variate', 'timeFrame': '12 months from enrollment', 'description': 'LogMAR (logarithm of the Minimum Angle of Resolution) is a measure of visual acuity in which the smaller values indicate better visual acuity.'}, {'measure': 'Best Spectacle-corrected Visual Acuity (BSCVA) in logMAR Using MIC (Minimum Inhibitory Concentration) to Moxifloxacin as a Covariate', 'timeFrame': '3 months after enrollment', 'description': 'Best spectacle-corrected visual acuity (BSCVA) for this outcome is measured in logMAR (logarithm of the Minimum Angle of Resolution) in which smaller values indicate better visual acuity. Minimum inhibitory concentration (MIC) to moxifloxacin was measured by E test and a log2-transformation of MIC was used in all analyses. In this analysis we add MIC to the model examining BSCVA at 3 months.'}, {'measure': 'Subgroup Analysis Predicting 3 Month Best Spectacle-corrected Visual Acuity (BSCVA) by Causative Organism', 'timeFrame': '3 months after enrollment', 'description': 'BSCVA measured in logMAR will be estimated by causative organism (either Nocardia spp, Streptococcus pneumoniae, Moraxella spp, or Pseudomonas aeruginosa). BSCVA will be examined for each causative organism by mean and standard deviation as well as in a regression model.'}, {'measure': 'Subgroup Analysis Predicting 3 Month Best Spectacle-corrected Visual Acuity (BSCVA) by Visual Acuity Group', 'timeFrame': '3 months from enrollment', 'description': 'Best spectacle-corrected visual acuity (BSCVA) for this subgroup analysis was measured in logMAR and then categorized by equivalent Snellen fractions'}, {'measure': 'Subgroup Analysis of Best Spectacle-corrected Visual Acuity (BSCVA) by Categories of Infiltrate Depth', 'timeFrame': '3 months from enrollment', 'description': 'BSCVA measured in logMAR will be examined by categories infiltrate depth (categorized by depth percentage) by mean and standard deviation as well as in a regression model.'}, {'measure': 'Subgroup Analysis Predicting Best Spectacle-corrected Visual Acuity (BSCVA) as Stratified by Categories of Infiltrate/Scar Size', 'timeFrame': '3 months from enrollment', 'description': 'Best-spectacle visual acuity (BSCVA) at 3 months from enrollment is stratified by categories of infiltrate/scar size and examined by treatment arm'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bacterial Infections', 'Eye Diseases', 'Bacterial Keratitis', 'Visual Acuity'], 'conditions': ['Corneal Ulcer', 'Eye Infections, Bacterial']}, 'referencesModule': {'references': [{'pmid': '21987581', 'type': 'BACKGROUND', 'citation': 'Srinivasan M, Mascarenhas J, Rajaraman R, Ravindran M, Lalitha P, Glidden DV, Ray KJ, Hong KC, Oldenburg CE, Lee SM, Zegans ME, McLeod SD, Lietman TM, Acharya NR; Steroids for Corneal Ulcers Trial Group. The steroids for corneal ulcers trial: study design and baseline characteristics. Arch Ophthalmol. 2012 Feb;130(2):151-7. doi: 10.1001/archophthalmol.2011.303. Epub 2011 Oct 10.'}, {'pmid': '21987582', 'type': 'RESULT', 'citation': 'Srinivasan M, Mascarenhas J, Rajaraman R, Ravindran M, Lalitha P, Glidden DV, Ray KJ, Hong KC, Oldenburg CE, Lee SM, Zegans ME, McLeod SD, Lietman TM, Acharya NR; Steroids for Corneal Ulcers Trial Group. Corticosteroids for bacterial keratitis: the Steroids for Corneal Ulcers Trial (SCUT). Arch Ophthalmol. 2012 Feb;130(2):143-50. doi: 10.1001/archophthalmol.2011.315. Epub 2011 Oct 10.'}, {'pmid': '27631025', 'type': 'DERIVED', 'citation': 'Hammond JH, Hebert WP, Naimie A, Ray K, Van Gelder RD, DiGiandomenico A, Lalitha P, Srinivasan M, Acharya NR, Lietman T, Hogan DA, Zegans ME. Environmentally Endemic Pseudomonas aeruginosa Strains with Mutations in lasR Are Associated with Increased Disease Severity in Corneal Ulcers. mSphere. 2016 Sep 7;1(5):e00140-16. doi: 10.1128/mSphere.00140-16. eCollection 2016 Sep-Oct.'}, {'pmid': '24618327', 'type': 'DERIVED', 'citation': "McClintic SM, Prajna NV, Srinivasan M, Mascarenhas J, Lalitha P, Rajaraman R, Oldenburg CE, O'Brien KS, Ray KJ, Acharya NR, Lietman TM, Keenan JD. Visual outcomes in treated bacterial keratitis: four years of prospective follow-up. Invest Ophthalmol Vis Sci. 2014 May 2;55(5):2935-40. doi: 10.1167/iovs.14-13980."}, {'pmid': '24612976', 'type': 'DERIVED', 'citation': 'Srinivasan M, Mascarenhas J, Rajaraman R, Ravindran M, Lalitha P, Ray KJ, Zegans ME, Acharya NR, Lietman TM, Keenan JD; Steroids for Corneal Ulcers Trial Group. Visual recovery in treated bacterial keratitis. Ophthalmology. 2014 Jun;121(6):1310-1. doi: 10.1016/j.ophtha.2013.12.041. Epub 2014 Mar 5.'}, {'pmid': '24315294', 'type': 'DERIVED', 'citation': "Srinivasan M, Mascarenhas J, Rajaraman R, Ravindran M, Lalitha P, O'Brien KS, Glidden DV, Ray KJ, Oldenburg CE, Zegans ME, Whitcher JP, McLeod SD, Porco TC, Lietman TM, Acharya NR; Steroids for Corneal Ulcers Trial Group. The steroids for corneal ulcers trial (SCUT): secondary 12-month clinical outcomes of a randomized controlled trial. Am J Ophthalmol. 2014 Feb;157(2):327-333.e3. doi: 10.1016/j.ajo.2013.09.025. Epub 2013 Oct 1."}, {'pmid': '23385795', 'type': 'DERIVED', 'citation': 'Oldenburg CE, Lalitha P, Srinivasan M, Manikandan P, Bharathi MJ, Rajaraman R, Ravindran M, Mascarenhas J, Nardone N, Ray KJ, Glidden DV, Acharya NR, Lietman TM. Moxifloxacin susceptibility mediates the relationship between causative organism and clinical outcome in bacterial keratitis. Invest Ophthalmol Vis Sci. 2013 Feb 28;54(2):1522-6. doi: 10.1167/iovs.12-11246.'}, {'pmid': '23307105', 'type': 'DERIVED', 'citation': 'Ray KJ, Prajna L, Srinivasan M, Geetha M, Karpagam R, Glidden D, Oldenburg CE, Sun CQ, McLeod SD, Acharya NR, Lietman TM. Fluoroquinolone treatment and susceptibility of isolates from bacterial keratitis. JAMA Ophthalmol. 2013 Mar;131(3):310-3. doi: 10.1001/jamaophthalmol.2013.1718.'}, {'pmid': '22959881', 'type': 'DERIVED', 'citation': 'Lalitha P, Srinivasan M, Rajaraman R, Ravindran M, Mascarenhas J, Priya JL, Sy A, Oldenburg CE, Ray KJ, Zegans ME, McLeod SD, Lietman TM, Acharya NR. Nocardia keratitis: clinical course and effect of corticosteroids. Am J Ophthalmol. 2012 Dec;154(6):934-939.e1. doi: 10.1016/j.ajo.2012.06.001. Epub 2012 Sep 5.'}, {'pmid': '22447793', 'type': 'DERIVED', 'citation': 'Lalitha P, Srinivasan M, Manikandan P, Bharathi MJ, Rajaraman R, Ravindran M, Cevallos V, Oldenburg CE, Ray KJ, Toutain-Kidd CM, Glidden DV, Zegans ME, McLeod SD, Acharya NR, Lietman TM. Relationship of in vitro susceptibility to moxifloxacin and in vivo clinical outcome in bacterial keratitis. Clin Infect Dis. 2012 May;54(10):1381-7. doi: 10.1093/cid/cis189. Epub 2012 Mar 23.'}, {'pmid': '22395880', 'type': 'DERIVED', 'citation': 'Dalmon C, Porco TC, Lietman TM, Prajna NV, Prajna L, Das MR, Kumar JA, Mascarenhas J, Margolis TP, Whitcher JP, Jeng BH, Keenan JD, Chan MF, McLeod SD, Acharya NR. The clinical differentiation of bacterial and fungal keratitis: a photographic survey. Invest Ophthalmol Vis Sci. 2012 Apr 2;53(4):1787-91. doi: 10.1167/iovs.11-8478.'}, {'pmid': '22159005', 'type': 'DERIVED', 'citation': 'Sy A, Srinivasan M, Mascarenhas J, Lalitha P, Rajaraman R, Ravindran M, Oldenburg CE, Ray KJ, Glidden D, Zegans ME, McLeod SD, Lietman TM, Acharya NR. Pseudomonas aeruginosa keratitis: outcomes and response to corticosteroid treatment. Invest Ophthalmol Vis Sci. 2012 Jan 25;53(1):267-72. doi: 10.1167/iovs.11-7840.'}, {'pmid': '18829631', 'type': 'DERIVED', 'citation': 'Srinivasan M, Lalitha P, Mahalakshmi R, Prajna NV, Mascarenhas J, Chidambaram JD, Lee S, Hong KC, Zegans M, Glidden DV, McLeod S, Whitcher JP, Lietman TM, Acharya NR. Corticosteroids for bacterial corneal ulcers. Br J Ophthalmol. 2009 Feb;93(2):198-202. doi: 10.1136/bjo.2008.147298. Epub 2008 Oct 1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether adding topical steroids improves the outcomes of bacterial corneal ulcers, especially visual acuity.', 'detailedDescription': 'Antimicrobial treatment of a bacterial corneal ulcer is generally effective in eradicating infection. However, "successful" treatment is not always associated with a good visual outcome. The scarring that accompanies the resolution of infection leaves many eyes blind. Some cornea specialists advocate the use of topical corticosteroids along with antibiotics in an effort to reduce immune-mediated tissue damage and scarring. Others fear using steroids to reduce the cornea\'s immune response will prolong or even exacerbate infection. Ophthalmologists have been divided on this issue for more than 30 years, and both approaches are acceptable according to the American Academy of Ophthalmology\'s Preferred Practice Patterns. Evidence from animal and human reports is mixed. A single randomized trial saw a non-significant benefit to steroids but was drastically underpowered (20 patients per study arm).\n\nThe study is a randomized, double-masked, placebo-controlled trial to determine whether adding topical steroids improves the outcomes of bacterial corneal ulcers. Five hundred bacterial corneal ulcers presenting to the Aravind Eye Hospitals, the University of California, San Francisco (UCSF) Proctor Foundation, and the Dartmouth-Hitchcock Medical Center will be randomized to receive antibiotic plus steroid or antibiotic plus placebo. Participants will be followed closely until re-epithelialization and then rechecked at three weeks, three months and 12 months post enrollment. A subset of patients will be contacted for a follow-up visit four years post enrollment. The primary outcome is best spectacle-corrected visual acuity three months after enrollment, using best spectacle-corrected enrollment visual acuity as a co-variate.\n\nA pilot study was conducted from January 2005 to August 2005 at Aravind Eye Hospital to assess the feasibility and safety and to estimate the sample size of a larger main trial. Forty-two patients with culture-proven bacterial keratitis were enrolled. They were treated and followed up as in the main trial, up to three months from enrollment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nAt Presentation:\n\n* Presence of a corneal ulcer at presentation\n\nAt Enrollment:\n\n* Presence of bacteria on blood or chocolate agar culture\n* Antibiotic given for \\> 48 hours\n* The patient must be able to verbalize a basic understanding of the study after it is explained to the patient, as determined by physician examiner. This understanding must include a commitment to return for f/u visits.\n* Appropriate consent\n\nExclusion Criteria\n\nAt Presentation:\n\n* Overlying epithelial defect \\< 0.75 mm at its greatest width at presentation\n* Corneal perforation or impending perforation\n* Evidence of fungus on KOH, Giemsa at time of presentation\n* Evidence of acanthamoeba by stain\n* Evidence of herpetic keratitis by history or exam\n* Corneal scar not easily distinguishable from current ulcer\n* Use of a topical steroid in the affected eye during the course of the present ulcer, including use after the symptoms of the ulcer started but before presentation\n* Use of systemic prednisolone during the course of the present ulcer\n* Age less than 16 years (before 16th birthday)\n* Bilateral ulcers\n* Previous penetrating keratoplasty\n* Pregnancy (by history or urine test)\n* Immediate steroid use necessary due to surgery or other condition\n\nAt Enrollment:\n\n* Evidence of fungus on culture at time of enrollment\n* Absence of bacteria on blood or chocolate agar culture\n* Best spectacle-corrected vision worse than 6/60 in the fellow eye\n* Corneal perforation or descemetocele\n* Known allergy to study medications (steroid or preservative)\n* No light perception in the affected eye\n* Not willing to come to follow-up visits\n* Not willing to participate'}, 'identificationModule': {'nctId': 'NCT00324168', 'acronym': 'SCUT', 'briefTitle': 'Steroids for Corneal Ulcers Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Steroids for Corneal Ulcers Trial', 'orgStudyIdInfo': {'id': 'H9332-21899-05'}, 'secondaryIdInfos': [{'id': 'U10EY015114-01', 'link': 'https://reporter.nih.gov/quickSearch/U10EY015114-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: Antibiotics', 'Drug: Topical corticosteroid']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Antibiotics', 'Drug: Placebo']}], 'interventions': [{'name': 'Antibiotics', 'type': 'DRUG', 'otherNames': ['Vigamox'], 'description': 'moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization', 'armGroupLabels': ['1', '2']}, {'name': 'Topical corticosteroid', 'type': 'DRUG', 'description': 'prednisolone phosphate 1% with preservative four times a day for 1 week, then twice a day for 1 week, and finally once a day for 1 week', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, then twice a day for 1 week, and finally once a day for 1 week', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Proctor Foundation, UCSF', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'city': 'Coimbatore', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Aravind Eye Hospital', 'geoPoint': {'lat': 11.00555, 'lon': 76.96612}}, {'zip': '625 020', 'city': 'Madurai', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Aravind Eye Hospital', 'geoPoint': {'lat': 9.919, 'lon': 78.11953}}, {'city': 'Tirunelveli', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Aravind Eye Hospital', 'geoPoint': {'lat': 8.72742, 'lon': 77.6838}}], 'overallOfficials': [{'name': 'M. Srinivasan, M.S., O.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aravind Eye Hospital'}, {'name': 'Mike Zegans, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth-Hitchcock Medical Center'}, {'name': 'Nisha Acharya, M.D., M.S.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Proctor Foundation, UCSF'}, {'name': 'Thomas M Lietman, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Proctor Foundation, UCSF'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas M. Lietman', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aravind Eye Hospitals, India', 'class': 'OTHER'}, {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, {'name': 'National Eye Institute (NEI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prinicpal Investigator', 'investigatorFullName': 'Thomas M. Lietman', 'investigatorAffiliation': 'University of California, San Francisco'}}}}