Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-01-12 @ 7:56 AM
Study NCT ID:
NCT01107405
Status:
COMPLETED
Last Update Posted:
2012-03-21
First Post:
2010-04-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Loteprednol Ophthalmic Base Compared to Loteprednol Ophthalmic Suspension vs Placebo in an Allergen Challenge
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003233', 'term': 'Conjunctivitis, Allergic'}], 'ancestors': [{'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C494814', 'term': 'BID protein, human'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tuyen.ong@bausch.com', 'phone': '(973) 360-6389', 'title': 'Tuyen Ong, MD MRCOphth', 'organization': 'Bausch & Lomb Incorporated'}, 'certainAgreement': {'otherDetails': 'Prior to any presentation of results, draft versions of manuscripts will be made available to co-authors and to the Sponsor for review and comment. At least 30 days in the case of abstracts or 60 days in the case of full papers should be allowed for comments prior to submission for consideration of acceptance of presentation or publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '14 days', 'eventGroups': [{'id': 'EG000', 'title': 'Loteprednol Etabonate Base (QD)', 'description': 'Loteprednol etabonate ophthalmic base dosed once/day.', 'otherNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Loteprednol Etabonate Base (BID)', 'description': 'Loteprednol etabonate ophthalmic base dosed two times/day', 'otherNumAtRisk': 20, 'otherNumAffected': 4, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Loteprednol Etabonate Base (QID)', 'description': 'Loteprednol etabonate ophthalmic base dosed four times/day.', 'otherNumAtRisk': 20, 'otherNumAffected': 5, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Loteprednol Etabonate Suspension (QID)', 'description': 'Loteprednol etabonate ophthalmic suspension dosed four times/day', 'otherNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Vehicle of Loteprednol Etabonate', 'description': 'Vehicle of loteprednol etabonate, dosed either QD, BID, or QID', 'otherNumAtRisk': 20, 'otherNumAffected': 6, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Eye pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Temporomandibular joint syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Oropharyngial pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Post nasal drip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Blood oestrogen decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ocular Itching', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Loteprednol Etabonate Base (QD)', 'description': 'Loteprednol etabonate ophthalmic base dosed once/day.'}, {'id': 'OG001', 'title': 'Loteprednol Etabonate Base (BID)', 'description': 'Loteprednol etabonate ophthalmic base dosed two times/day'}, {'id': 'OG002', 'title': 'Loteprednol Etabonate Base (QID)', 'description': 'Loteprednol etabonate ophthalmic base dosed four times/day.'}, {'id': 'OG003', 'title': 'Loteprednol Etabonate Suspension (QID)', 'description': 'Loteprednol etabonate ophthalmic suspension dosed four times/day'}, {'id': 'OG004', 'title': 'Vehicle of Loteprednol Etabonate', 'description': 'Vehicle of loteprednol etabonate, dosed either QD, BID, or QID'}], 'classes': [{'title': '3 Min', 'categories': [{'measurements': [{'value': '1.48', 'spread': '1.040', 'groupId': 'OG000'}, {'value': '1.84', 'spread': '0.978', 'groupId': 'OG001'}, {'value': '1.82', 'spread': '0.954', 'groupId': 'OG002'}, {'value': '1.93', 'spread': '0.794', 'groupId': 'OG003'}, {'value': '2.68', 'spread': '0.916', 'groupId': 'OG004'}]}]}, {'title': '5 Min', 'categories': [{'measurements': [{'value': '1.63', 'spread': '1.036', 'groupId': 'OG000'}, {'value': '2.13', 'spread': '0.988', 'groupId': 'OG001'}, {'value': '1.96', 'spread': '0.960', 'groupId': 'OG002'}, {'value': '2.12', 'spread': '0.918', 'groupId': 'OG003'}, {'value': '2.78', 'spread': '0.924', 'groupId': 'OG004'}]}]}, {'title': '7 Min', 'categories': [{'measurements': [{'value': '1.54', 'spread': '1.035', 'groupId': 'OG000'}, {'value': '2.03', 'spread': '1.097', 'groupId': 'OG001'}, {'value': '1.89', 'spread': '0.993', 'groupId': 'OG002'}, {'value': '2.04', 'spread': '0.951', 'groupId': 'OG003'}, {'value': '2.71', 'spread': '0.899', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 4 (8 hr re-challenge)', 'description': 'Evaluated by subject at 3, 5, and 7 min post challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Visit 4, Re-challenge Ocular Itching Scores - Primary Analysis ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.'}, {'type': 'PRIMARY', 'title': 'Conjunctival Redness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Loteprednol Etabonate Base (QD)', 'description': 'Loteprednol etabonate ophthalmic base dosed once/day.'}, {'id': 'OG001', 'title': 'Loteprednol Etabonate Base (BID)', 'description': 'Loteprednol etabonate ophthalmic base dosed two times/day'}, {'id': 'OG002', 'title': 'Loteprednol Etabonate Base (QID)', 'description': 'Loteprednol etabonate ophthalmic base dosed four times/day.'}, {'id': 'OG003', 'title': 'Loteprednol Etabonate Suspension (QID)', 'description': 'Loteprednol etabonate ophthalmic suspension dosed four times/day'}, {'id': 'OG004', 'title': 'Vehicle of Loteprednol Etabonate', 'description': 'Vehicle of loteprednol etabonate, dosed either QD, BID, or QID'}], 'classes': [{'title': '7 min', 'categories': [{'measurements': [{'value': '1.76', 'spread': '0.620', 'groupId': 'OG000'}, {'value': '1.99', 'spread': '0.709', 'groupId': 'OG001'}, {'value': '2.11', 'spread': '0.649', 'groupId': 'OG002'}, {'value': '2.16', 'spread': '0.619', 'groupId': 'OG003'}, {'value': '2.59', 'spread': '0.501', 'groupId': 'OG004'}]}]}, {'title': '15 min', 'categories': [{'measurements': [{'value': '1.95', 'spread': '0.660', 'groupId': 'OG000'}, {'value': '2.13', 'spread': '0.829', 'groupId': 'OG001'}, {'value': '2.28', 'spread': '0.766', 'groupId': 'OG002'}, {'value': '2.18', 'spread': '0.600', 'groupId': 'OG003'}, {'value': '2.71', 'spread': '0.597', 'groupId': 'OG004'}]}]}, {'title': '20 min', 'categories': [{'measurements': [{'value': '2.02', 'spread': '0.720', 'groupId': 'OG000'}, {'value': '2.06', 'spread': '0.811', 'groupId': 'OG001'}, {'value': '2.28', 'spread': '0.691', 'groupId': 'OG002'}, {'value': '2.16', 'spread': '0.585', 'groupId': 'OG003'}, {'value': '2.74', 'spread': '0.592', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 4 (8 hr re-challenge)', 'description': 'Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Visit 4, Re-challenge Conjunctival Hyperemia Scores, ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.'}, {'type': 'SECONDARY', 'title': 'Ocular Itching', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Loteprednol Etabonate Base (QD)', 'description': 'Loteprednol etabonate ophthalmic base dosed once/day.'}, {'id': 'OG001', 'title': 'Loteprednol Etabonate Base (BID)', 'description': 'Loteprednol etabonate ophthalmic base dosed two times/day'}, {'id': 'OG002', 'title': 'Loteprednol Etabonate Base (QID)', 'description': 'Loteprednol etabonate ophthalmic base dosed four times/day.'}, {'id': 'OG003', 'title': 'Loteprednol Etabonate Suspension (QID)', 'description': 'Loteprednol etabonate ophthalmic suspension dosed four times/day'}, {'id': 'OG004', 'title': 'Vehicle of Loteprednol Etabonate', 'description': 'Vehicle of loteprednol etabonate, dosed either QD, BID, or QID'}], 'classes': [{'title': '3 Min', 'categories': [{'measurements': [{'value': '2.50', 'spread': '0.829', 'groupId': 'OG000'}, {'value': '2.00', 'spread': '0.778', 'groupId': 'OG001'}, {'value': '2.31', 'spread': '0.889', 'groupId': 'OG002'}, {'value': '2.28', 'spread': '0.946', 'groupId': 'OG003'}, {'value': '2.50', 'spread': '1.000', 'groupId': 'OG004'}]}]}, {'title': '5 min', 'categories': [{'measurements': [{'value': '2.45', 'spread': '0.781', 'groupId': 'OG000'}, {'value': '2.15', 'spread': '0.745', 'groupId': 'OG001'}, {'value': '2.46', 'spread': '1.016', 'groupId': 'OG002'}, {'value': '2.47', 'spread': '0.979', 'groupId': 'OG003'}, {'value': '2.63', 'spread': '0.863', 'groupId': 'OG004'}]}]}, {'title': '7 min', 'categories': [{'measurements': [{'value': '2.38', 'spread': '0.872', 'groupId': 'OG000'}, {'value': '2.21', 'spread': '0.783', 'groupId': 'OG001'}, {'value': '2.21', 'spread': '1.044', 'groupId': 'OG002'}, {'value': '2.38', 'spread': '1.062', 'groupId': 'OG003'}, {'value': '2.45', 'spread': '0.810', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 3 (initial challenge)', 'description': 'Evaluated by the subject at 3, 5 and 7 min post-challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Visit 3 Ocular Itching Scores - ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.'}, {'type': 'SECONDARY', 'title': 'Conjunctival Redness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Loteprednol Etabonate Base (QD)', 'description': 'Loteprednol etabonate ophthalmic base dosed once/day.'}, {'id': 'OG001', 'title': 'Loteprednol Etabonate Base (BID)', 'description': 'Loteprednol etabonate ophthalmic base dosed two times/day'}, {'id': 'OG002', 'title': 'Loteprednol Etabonate Base (QID)', 'description': 'Loteprednol etabonate ophthalmic base dosed four times/day.'}, {'id': 'OG003', 'title': 'Loteprednol Etabonate Suspension (QID)', 'description': 'Loteprednol etabonate ophthalmic suspension dosed four times/day'}, {'id': 'OG004', 'title': 'Vehicle of Loteprednol Etabonate', 'description': 'Vehicle of loteprednol etabonate, dosed either QD, BID, or QID'}], 'classes': [{'title': '7 min', 'categories': [{'measurements': [{'value': '2.14', 'spread': '0.584', 'groupId': 'OG000'}, {'value': '2.05', 'spread': '0.484', 'groupId': 'OG001'}, {'value': '2.22', 'spread': '0.593', 'groupId': 'OG002'}, {'value': '2.25', 'spread': '0.486', 'groupId': 'OG003'}, {'value': '2.41', 'spread': '0.663', 'groupId': 'OG004'}]}]}, {'title': '15 min', 'categories': [{'measurements': [{'value': '2.26', 'spread': '0.509', 'groupId': 'OG000'}, {'value': '2.20', 'spread': '0.737', 'groupId': 'OG001'}, {'value': '2.28', 'spread': '0.664', 'groupId': 'OG002'}, {'value': '2.43', 'spread': '0.415', 'groupId': 'OG003'}, {'value': '2.42', 'spread': '0.795', 'groupId': 'OG004'}]}]}, {'title': '20 min', 'categories': [{'measurements': [{'value': '2.31', 'spread': '0.541', 'groupId': 'OG000'}, {'value': '2.24', 'spread': '0.631', 'groupId': 'OG001'}, {'value': '2.18', 'spread': '0.706', 'groupId': 'OG002'}, {'value': '2.33', 'spread': '0.590', 'groupId': 'OG003'}, {'value': '2.42', 'spread': '0.834', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 3 (initial challenge)', 'description': 'Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Visit 3 Conjunctival Hyperemia Scores - ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.'}, {'type': 'SECONDARY', 'title': 'Ocular Itching', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Loteprednol Etabonate Base (QD)', 'description': 'Loteprednol etabonate ophthalmic base dosed once/day.'}, {'id': 'OG001', 'title': 'Loteprednol Etabonate Base (BID)', 'description': 'Loteprednol etabonate ophthalmic base dosed two times/day'}, {'id': 'OG002', 'title': 'Loteprednol Etabonate Base (QID)', 'description': 'Loteprednol etabonate ophthalmic base dosed four times/day.'}, {'id': 'OG003', 'title': 'Loteprednol Etabonate Suspension (QID)', 'description': 'Loteprednol etabonate ophthalmic suspension dosed four times/day'}, {'id': 'OG004', 'title': 'Vehicle of Loteprednol Etabonate', 'description': 'Vehicle of loteprednol etabonate, dosed either QD, BID, or QID'}], 'classes': [{'title': '3 Min', 'categories': [{'measurements': [{'value': '2.02', 'spread': '0.978', 'groupId': 'OG000'}, {'value': '1.93', 'spread': '1.130', 'groupId': 'OG001'}, {'value': '2.04', 'spread': '0.913', 'groupId': 'OG002'}, {'value': '2.17', 'spread': '0.846', 'groupId': 'OG003'}, {'value': '2.55', 'spread': '0.880', 'groupId': 'OG004'}]}]}, {'title': '5 min', 'categories': [{'measurements': [{'value': '2.19', 'spread': '1.040', 'groupId': 'OG000'}, {'value': '2.14', 'spread': '1.071', 'groupId': 'OG001'}, {'value': '2.15', 'spread': '0.888', 'groupId': 'OG002'}, {'value': '2.32', 'spread': '0.853', 'groupId': 'OG003'}, {'value': '2.82', 'spread': '0.877', 'groupId': 'OG004'}]}]}, {'title': '7 min', 'categories': [{'measurements': [{'value': '2.11', 'spread': '1.026', 'groupId': 'OG000'}, {'value': '2.11', 'spread': '0.985', 'groupId': 'OG001'}, {'value': '2.13', 'spread': '0.917', 'groupId': 'OG002'}, {'value': '2.22', 'spread': '0.953', 'groupId': 'OG003'}, {'value': '2.71', 'spread': '0.875', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 4 (initial challenge)', 'description': 'Evaluated by the subject at 3, 5 and 7 min post-challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Visit 4 Ocular Itching Scores - ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.'}, {'type': 'SECONDARY', 'title': 'Conjunctival Redness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Loteprednol Etabonate Base (QD)', 'description': 'Loteprednol etabonate ophthalmic base dosed once/day.'}, {'id': 'OG001', 'title': 'Loteprednol Etabonate Base (BID)', 'description': 'Loteprednol etabonate ophthalmic base dosed two times/day'}, {'id': 'OG002', 'title': 'Loteprednol Etabonate Base (QID)', 'description': 'Loteprednol etabonate ophthalmic base dosed four times/day.'}, {'id': 'OG003', 'title': 'Loteprednol Etabonate Suspension (QID)', 'description': 'Loteprednol etabonate ophthalmic suspension dosed four times/day'}, {'id': 'OG004', 'title': 'Vehicle of Loteprednol Etabonate', 'description': 'Vehicle of loteprednol etabonate, dosed either QD, BID, or QID'}], 'classes': [{'title': '7 min', 'categories': [{'measurements': [{'value': '1.96', 'spread': '0.755', 'groupId': 'OG000'}, {'value': '2.19', 'spread': '0.683', 'groupId': 'OG001'}, {'value': '2.26', 'spread': '0.661', 'groupId': 'OG002'}, {'value': '2.22', 'spread': '0.353', 'groupId': 'OG003'}, {'value': '2.70', 'spread': '0.445', 'groupId': 'OG004'}]}]}, {'title': '15 min', 'categories': [{'measurements': [{'value': '2.05', 'spread': '0.793', 'groupId': 'OG000'}, {'value': '2.19', 'spread': '0.777', 'groupId': 'OG001'}, {'value': '2.28', 'spread': '0.717', 'groupId': 'OG002'}, {'value': '2.36', 'spread': '0.459', 'groupId': 'OG003'}, {'value': '2.83', 'spread': '0.479', 'groupId': 'OG004'}]}]}, {'title': '20 min', 'categories': [{'measurements': [{'value': '2.15', 'spread': '0.777', 'groupId': 'OG000'}, {'value': '2.16', 'spread': '0.828', 'groupId': 'OG001'}, {'value': '2.28', 'spread': '0.701', 'groupId': 'OG002'}, {'value': '2.29', 'spread': '0.573', 'groupId': 'OG003'}, {'value': '2.80', 'spread': '0.544', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 4 (initial challenge)', 'description': 'Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Visit 4 Conjunctival Hyperemia Scores - ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Loteprednol Etabonate Base (QD)', 'description': 'Loteprednol etabonate ophthalmic base dosed once/day.'}, {'id': 'FG001', 'title': 'Loteprednol Etabonate Base (BID)', 'description': 'Loteprednol etabonate ophthalmic base dosed two times/day'}, {'id': 'FG002', 'title': 'Loteprednol Etabonate Base (QID)', 'description': 'Loteprednol etabonate ophthalmic base dosed four times/day.'}, {'id': 'FG003', 'title': 'Loteprednol Etabonate Suspension (QID)', 'description': 'Loteprednol etabonate ophthalmic suspension dosed four times/day'}, {'id': 'FG004', 'title': 'Vehicle of Loteprednol Etabonate', 'description': 'Vehicle of loteprednol etabonate, dosed either QD, BID, or QID'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '20'}, {'groupId': 'FG004', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This 2 week ocular allergy study was conducted at 2 ophthalmology clinics in the United States. The first participant was enrolled on 4/22/2010 and the last participant visit was 5/30/2010.', 'preAssignmentDetails': '238 participants were screened, a total of 101 participants with seasonal and perennial allergy were randomized into the study. These 101 participants comprised the safety population, 90 of which completed the study. The ITT population was comprised of 97 subjects (4 excluded due to no post CAC-assessment).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '101', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Loteprednol Etabonate Base (QD)', 'description': 'Loteprednol etabonate ophthalmic base dosed once/day.'}, {'id': 'BG001', 'title': 'Loteprednol Etabonate Base (BID)', 'description': 'Loteprednol etabonate ophthalmic base dosed two times/day'}, {'id': 'BG002', 'title': 'Loteprednol Etabonate Base (QID)', 'description': 'Loteprednol etabonate ophthalmic base dosed four times/day.'}, {'id': 'BG003', 'title': 'Loteprednol Etabonate Suspension (QID)', 'description': 'Loteprednol etabonate ophthalmic suspension dosed four times/day'}, {'id': 'BG004', 'title': 'Vehicle of Loteprednol Etabonate', 'description': 'Vehicle of loteprednol etabonate, dosed either QD, BID, or QID'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<=19 years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}]}]}, {'title': '20 - 64 years', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '91', 'groupId': 'BG005'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '60', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '41', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '98', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-14', 'studyFirstSubmitDate': '2010-04-15', 'resultsFirstSubmitDate': '2011-09-21', 'studyFirstSubmitQcDate': '2010-04-19', 'lastUpdatePostDateStruct': {'date': '2012-03-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-02-14', 'studyFirstPostDateStruct': {'date': '2010-04-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular Itching', 'timeFrame': 'Visit 4 (8 hr re-challenge)', 'description': 'Evaluated by subject at 3, 5, and 7 min post challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.'}, {'measure': 'Conjunctival Redness', 'timeFrame': 'Visit 4 (8 hr re-challenge)', 'description': 'Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.'}], 'secondaryOutcomes': [{'measure': 'Ocular Itching', 'timeFrame': 'Visit 3 (initial challenge)', 'description': 'Evaluated by the subject at 3, 5 and 7 min post-challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.'}, {'measure': 'Conjunctival Redness', 'timeFrame': 'Visit 3 (initial challenge)', 'description': 'Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.'}, {'measure': 'Ocular Itching', 'timeFrame': 'Visit 4 (initial challenge)', 'description': 'Evaluated by the subject at 3, 5 and 7 min post-challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.'}, {'measure': 'Conjunctival Redness', 'timeFrame': 'Visit 4 (initial challenge)', 'description': 'Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Allergic Conjunctivitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of loteprednol etabonate ophthalmic base, compared to loteprednol etabonate ophthalmic suspension, and vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in a modified Conjunctival Allergen Challenge model and in an environmental model during pollen season. Comparisons will be made following 2 weeks of dosing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months.\n* Calculated best-corrected visual acuity of 0.70 logMAR or better in each eye as measured using the ETDRS chart.\n* Positive bilateral conjunctival allergen challenge(CAC)reaction within 10 minutes of instillation of the last titration of allergen at visit 1.\n* Positive bilateral CAC reaction in 1 out of 3 time points for the initial and re-challenge at visit 2.\n\nExclusion Criteria:\n\n* Known contraindications or sensitivities to the study medication or its components.\n* Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.\n* Use of disallowed medications during the period indicated prior to study enrollment or during the study.'}, 'identificationModule': {'nctId': 'NCT01107405', 'briefTitle': 'Loteprednol Ophthalmic Base Compared to Loteprednol Ophthalmic Suspension vs Placebo in an Allergen Challenge', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch & Lomb Incorporated'}, 'officialTitle': 'Efficacy of Loteprednol Etabonate Ophthalmic Base Compared to Loteprednol Etabonate Ophthalmic Suspension vs Placebo in a Modified Conjunctival Allergen Challenge(CAC) Model', 'orgStudyIdInfo': {'id': '584'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Loteprednol etabonate base (QD)', 'description': 'Loteprednol etabonate ophthalmic base dosed once/day.', 'interventionNames': ['Drug: Loteprednol etabonate base (QD)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Loteprednol etabonate base (BID)', 'description': 'Loteprednol etabonate ophthalmic base dosed two times/day', 'interventionNames': ['Drug: Loteprednol etabonate base (BID)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Loteprednol etabonate base (QID)', 'description': 'Loteprednol etabonate ophthalmic base dosed four times/day.', 'interventionNames': ['Drug: Loteprednol etabonate base (QID)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Loteprednol etabonate suspension (QID)', 'description': 'Loteprednol etabonate ophthalmic suspension dosed four times/day', 'interventionNames': ['Drug: Loteprednol etabonate suspension']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle of loteprednol etabonate', 'description': 'Vehicle of loteprednol etabonate, dosed either QD, BID, or QID', 'interventionNames': ['Drug: Vehicle of loteprednol etabonate']}], 'interventions': [{'name': 'Loteprednol etabonate base (QD)', 'type': 'DRUG', 'description': 'Loteprednol Etabonate ophthalmic base once daily dosing for 2 weeks', 'armGroupLabels': ['Loteprednol etabonate base (QD)']}, {'name': 'Loteprednol etabonate base (BID)', 'type': 'DRUG', 'description': 'Loteprednol etabonate ophthalmic base BID dosing for 2 weeks', 'armGroupLabels': ['Loteprednol etabonate base (BID)']}, {'name': 'Loteprednol etabonate base (QID)', 'type': 'DRUG', 'description': 'Loteprednol Etabonate ophthalmic base four times/day dosing for 2 week', 'armGroupLabels': ['Loteprednol etabonate base (QID)']}, {'name': 'Loteprednol etabonate suspension', 'type': 'DRUG', 'description': 'Loteprednol etabonate ophthalmic suspension dosed four times daily for 2 weeks.', 'armGroupLabels': ['Loteprednol etabonate suspension (QID)']}, {'name': 'Vehicle of loteprednol etabonate', 'type': 'DRUG', 'description': 'Vehicle of loteprednol etabonate ophthalmic dosed once, twice or four times daily for 2 weeks.', 'armGroupLabels': ['Vehicle of loteprednol etabonate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14603', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Bausch & Lomb', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Tuyen Ong, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bausch & Lomb Incorporated'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}