Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2026-01-01 @ 2:44 PM
Study NCT ID:
NCT04735393
Status:
COMPLETED
Last Update Posted:
2025-11-26
First Post:
2021-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bcavanagh@aldeyra.com', 'phone': '781-257-3063', 'title': 'Director of Clinical Trials', 'organization': 'Aldeyra Therapeutics, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Safety assessment period (6 weeks or 12 months)', 'eventGroups': [{'id': 'EG000', 'title': 'Reproxalap (6-week)', 'description': 'Reproxalap was administered four times daily for four weeks followed by two times daily for two weeks.', 'otherNumAtRisk': 503, 'deathsNumAtRisk': 503, 'otherNumAffected': 205, 'seriousNumAtRisk': 503, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vehicle (6-week)', 'description': 'Vehicle was administered four times daily for four weeks followed by two times daily for two weeks.', 'otherNumAtRisk': 251, 'deathsNumAtRisk': 251, 'otherNumAffected': 8, 'seriousNumAtRisk': 251, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Reproxalap (12-month)', 'description': 'Reproxalap was administered four times daily for four weeks followed by two times daily for 11 months.', 'otherNumAtRisk': 299, 'deathsNumAtRisk': 299, 'otherNumAffected': 127, 'seriousNumAtRisk': 299, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Vehicle (12-month)', 'description': 'Vehicle was administered four times daily for four weeks followed by two times daily for 11 months.', 'otherNumAtRisk': 148, 'deathsNumAtRisk': 148, 'otherNumAffected': 3, 'seriousNumAtRisk': 148, 'deathsNumAffected': 2, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'General disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 503, 'numEvents': 205, 'numAffected': 205}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 127, 'numAffected': 127}, {'groupId': 'EG003', 'numAtRisk': 148, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Appendicitis', 'notes': 'The SAE was deemed not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 503, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID-19 Infection', 'notes': 'The SAE was deemed not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 503, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Unknown cause of death', 'notes': 'The SAE was deemed not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 503, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Premature ventricular contractions', 'notes': 'The SAE was deemed not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 503, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Unstable Angina', 'notes': 'The SAE was deemed not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 503, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 503, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right tonsil squamous cell carcinoma', 'notes': 'The SAE was deemed not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 503, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening of chronic back pain', 'notes': 'The SAE was deemed not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 503, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney infection', 'notes': 'The SAE was deemed not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 503, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Supraventricular Tachycardia', 'notes': 'The SAE was deemed not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 503, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Treatment-Emergent Serious Adverse Events (TE-SAEs) of Visual Acuity Decrease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '503', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reproxalap', 'description': 'Reproxalap was administered four times daily for four weeks followed by two times daily for either two weeks or 11 months.'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'Vehicle was administered four times daily for four weeks followed by two times daily for either two weeks or 11 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Safety assessment period (six weeks)', 'description': 'The proportion of 6-week safety population subjects that experience at least one visual acuity TE-SAE decrease (defined as an increase of 0.22 or greater in logMAR score) categorized as probably or definitely related to test article.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '6-week safety population'}, {'type': 'PRIMARY', 'title': 'TE-SAEs of Increase in Intraocular Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '503', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reproxalap', 'description': 'Reproxalap was administered four times daily for four weeks followed by two times daily for either two weeks or 11 months.'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'Vehicle was administered four times daily for four weeks followed by two times daily for either two weeks or 11 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Safety assessment period (six weeks)', 'description': 'The proportion of 6-week safety population subjects that experience at least one intraocular pressure TE-SAE (increase from baseline of greater than or equal to 10 mmHg and intraocular pressure of greater than 25 mmHg) categorized as probably or definitely related to test article.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '6-week safety population'}, {'type': 'PRIMARY', 'title': 'TE-SAEs of the Cornea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '503', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reproxalap', 'description': 'Reproxalap was administered four times daily for four weeks followed by two times daily for either two weeks or 11 months.'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'Vehicle was administered four times daily for four weeks followed by two times daily for either two weeks or 11 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Safety assessment period (six weeks)', 'description': 'The proportion of 6-week safety population subjects that experience at least one cornea-related TE-SAE (detected via slit-lamp examination) categorized as probably or definitely related to test article.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '6-week safety population'}, {'type': 'PRIMARY', 'title': 'TE-SAEs of the Retina', 'denoms': [{'units': 'Participants', 'counts': [{'value': '503', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reproxalap', 'description': 'Reproxalap was administered four times daily for four weeks followed by two times daily for either two weeks or 11 months.'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'Vehicle was administered four times daily for four weeks followed by two times daily for either two weeks or 11 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Safety assessment period (six weeks)', 'description': 'The proportion 6-week safety population subjects that experience at least one retinal TE-SAE (detected via fundoscopy) categorized as probably or definitely related to test article.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '6-week safety population'}, {'type': 'POST_HOC', 'title': 'Change From Baseline in Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '592', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reproxalap', 'description': 'Reproxalap was administered four times daily for four weeks followed by two times daily for 11 months.'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'Vehicle was administered four times daily for four weeks followed by two times daily for 11 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.030', 'spread': '0.0035', 'groupId': 'OG000'}, {'value': '-0.016', 'spread': '0.0046', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Efficacy assessment period (12 months)', 'description': 'Overall change from baseline in visual acuity logMAR score. Visual acuity values were averaged across both eyes for each participant.', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': '12-month primary safety analysis population'}, {'type': 'PRIMARY', 'title': 'TE-SAEs of Visual Acuity Decrease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reproxalap', 'description': 'Reproxalap was administered four times daily for four weeks followed by two times daily for either two weeks or 11 months.'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'Vehicle was administered four times daily for four weeks followed by two times daily for either two weeks or 11 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Safety assessment period (12 months)', 'description': 'The proportion of 12-month safety population subjects that experience at least one visual acuity TE-SAE (defined as an increase of 0.22 or greater in logMAR score) categorized as probably or definitely related to test article.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '12-month safety population'}, {'type': 'PRIMARY', 'title': 'TE-SAEs of Increase in Intraocular Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reproxalap', 'description': 'Reproxalap was administered four times daily for four weeks followed by two times daily for either two weeks or 11 months.'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'Vehicle was administered four times daily for four weeks followed by two times daily for either two weeks or 11 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Safety assessment period (12 months)', 'description': 'The proportion of 12-month safety population subjects that experience at least one intraocular pressure TE-SAE (increase from baseline of greater than or equal to 10 mmHg and intraocular pressure of greater than 25 mmHg) categorized as probably or definitely related to test article.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '12-month safety population'}, {'type': 'PRIMARY', 'title': 'TE-SAEs of the Cornea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reproxalap', 'description': 'Reproxalap was administered four times daily for four weeks followed by two times daily for either two weeks or 11 months.'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'Vehicle was administered four times daily for four weeks followed by two times daily for either two weeks or 11 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Safety assessment period (12 months)', 'description': 'The proportion of 12-month safety population subjects that experience at least one cornea-related TE-SAE (detected via slit-lamp examination) categorized as probably or definitely related to test article.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '12-month safety population'}, {'type': 'PRIMARY', 'title': 'TE-SAEs of the Retina', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reproxalap', 'description': 'Reproxalap was administered four times daily for four weeks followed by two times daily for either two weeks or 11 months.'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'Vehicle was administered four times daily for four weeks followed by two times daily for either two weeks or 11 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Safety assessment period (12-months)', 'description': 'The proportion 12-month safety population subjects that experience at least one retinal TE-SAE(detected via fundoscopy) categorized as probably or definitely related to test article.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '12-month safety population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Reproxalap', 'description': 'Reproxalap was administered four times daily for four weeks followed by two times daily for either two weeks or 11 months.'}, {'id': 'FG001', 'title': 'Vehicle', 'description': 'Vehicle was administered four times daily for four weeks followed by two times daily for either two weeks or 11 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '504'}, {'groupId': 'FG001', 'numSubjects': '253'}]}, {'type': 'As Treated', 'achievements': [{'comment': 'There were 504 subjects assigned to reproxalap. Three subjects were assigned to reproxalap and never dosed. One subject was assigned to reproxalap and were also dosed with vehicle.', 'groupId': 'FG000', 'numSubjects': '501'}, {'comment': 'There were 253 subjects assigned to vehicle. Three subjects were assigned to vehicle and never dosed. Two subjects were assigned to vehicle and were also dosed with reproxalap.', 'groupId': 'FG001', 'numSubjects': '250'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '273'}, {'groupId': 'FG001', 'numSubjects': '161'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '231'}, {'groupId': 'FG001', 'numSubjects': '92'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Not Detailed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Trial terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '29'}]}]}], 'preAssignmentDetails': 'The 6-week safety population are subjects randomized and treated in either the 6-week or 12-month cohort. The 12-month safety population are subjects randomized and treated in the 12-month cohort. There was a total of 757 randomized subjects in the trial. There were 6 subjects randomized and not dosed.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '503', 'groupId': 'BG000'}, {'value': '251', 'groupId': 'BG001'}, {'value': '754', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Reproxalap (6-week)', 'description': 'Reproxalap was administered four times daily for four weeks followed by two times daily for two weeks.'}, {'id': 'BG001', 'title': 'Vehicle (6-week)', 'description': 'Vehicle was administered four times daily for four weeks followed by two times daily for two weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '336', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '501', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '167', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '253', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.7', 'spread': '15.8', 'groupId': 'BG000'}, {'value': '56.9', 'spread': '15.8', 'groupId': 'BG001'}, {'value': '56.0', 'spread': '15.75', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '356', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '532', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '222', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '154', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '229', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '349', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '525', '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/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '343', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '505', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Multiple', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '6-week safety population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-16', 'size': 4528924, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-06-24T14:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 757}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'dispFirstSubmitDate': '2023-05-31', 'completionDateStruct': {'date': '2022-10-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2021-01-25', 'resultsFirstSubmitDate': '2025-10-17', 'studyFirstSubmitQcDate': '2021-02-01', 'dispFirstPostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-14', 'studyFirstPostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-10-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment-Emergent Serious Adverse Events (TE-SAEs) of Visual Acuity Decrease', 'timeFrame': 'Safety assessment period (six weeks)', 'description': 'The proportion of 6-week safety population subjects that experience at least one visual acuity TE-SAE decrease (defined as an increase of 0.22 or greater in logMAR score) categorized as probably or definitely related to test article.'}, {'measure': 'TE-SAEs of Increase in Intraocular Pressure', 'timeFrame': 'Safety assessment period (six weeks)', 'description': 'The proportion of 6-week safety population subjects that experience at least one intraocular pressure TE-SAE (increase from baseline of greater than or equal to 10 mmHg and intraocular pressure of greater than 25 mmHg) categorized as probably or definitely related to test article.'}, {'measure': 'TE-SAEs of the Cornea', 'timeFrame': 'Safety assessment period (six weeks)', 'description': 'The proportion of 6-week safety population subjects that experience at least one cornea-related TE-SAE (detected via slit-lamp examination) categorized as probably or definitely related to test article.'}, {'measure': 'TE-SAEs of the Retina', 'timeFrame': 'Safety assessment period (six weeks)', 'description': 'The proportion 6-week safety population subjects that experience at least one retinal TE-SAE (detected via fundoscopy) categorized as probably or definitely related to test article.'}, {'measure': 'TE-SAEs of Visual Acuity Decrease', 'timeFrame': 'Safety assessment period (12 months)', 'description': 'The proportion of 12-month safety population subjects that experience at least one visual acuity TE-SAE (defined as an increase of 0.22 or greater in logMAR score) categorized as probably or definitely related to test article.'}, {'measure': 'TE-SAEs of Increase in Intraocular Pressure', 'timeFrame': 'Safety assessment period (12 months)', 'description': 'The proportion of 12-month safety population subjects that experience at least one intraocular pressure TE-SAE (increase from baseline of greater than or equal to 10 mmHg and intraocular pressure of greater than 25 mmHg) categorized as probably or definitely related to test article.'}, {'measure': 'TE-SAEs of the Cornea', 'timeFrame': 'Safety assessment period (12 months)', 'description': 'The proportion of 12-month safety population subjects that experience at least one cornea-related TE-SAE (detected via slit-lamp examination) categorized as probably or definitely related to test article.'}, {'measure': 'TE-SAEs of the Retina', 'timeFrame': 'Safety assessment period (12-months)', 'description': 'The proportion 12-month safety population subjects that experience at least one retinal TE-SAE(detected via fundoscopy) categorized as probably or definitely related to test article.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye Disease']}, 'descriptionModule': {'briefSummary': 'A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of 0.25% Reproxalap Ophthalmic Solution in Subjects with Dry Eye Disease'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age (either gender and any race);\n* Reported history of dry eye for at least 6 months prior to Visit 1;\n* History of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1.\n\nExclusion Criteria:\n\n* Clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;\n* Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;\n* Contact lens use within 7 days of Visit 1 or anticipate using contact lenses during the trial;\n* Eye drop use within 2 hours of Visit 1;\n* Previous laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;\n* Cyclosporine 0.05% or 0.09% or lifitegrast 5.0% ophthalmic solution within 90 days of Visit 1;\n* Planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1;\n* Temporary punctal plugs during the study that have not been stable within 30 days of Visit 1.'}, 'identificationModule': {'nctId': 'NCT04735393', 'briefTitle': 'A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aldeyra Therapeutics, Inc.'}, 'officialTitle': 'A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of 0.25% Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease', 'orgStudyIdInfo': {'id': 'ADX-102-DED-021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reproxalap (0.25%) for six weeks', 'description': 'Reproxalap four times daily (QID) for four weeks followed by two times daily (BID) for two weeks', 'interventionNames': ['Drug: Reproxalap Ophthalmic Solution (0.25%)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle for six weeks', 'description': 'Vehicle QID for four weeks followed by BID for two weeks', 'interventionNames': ['Drug: Placebo Comparator']}, {'type': 'EXPERIMENTAL', 'label': 'Reproxalap (0.25%) for 12 months', 'description': 'Reproxalap (0.25%) QID for four weeks followed by BID for 11 months', 'interventionNames': ['Drug: Reproxalap Ophthalmic Solution (0.25%)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle for 12 months', 'description': 'Vehicle QID for four weeks followed by BID for 11 months', 'interventionNames': ['Drug: Placebo Comparator']}], 'interventions': [{'name': 'Reproxalap Ophthalmic Solution (0.25%)', 'type': 'DRUG', 'description': 'Reproxalap Ophthalmic Solution (0.25%) administered for six weeks (QID for four weeks then BID for two weeks).', 'armGroupLabels': ['Reproxalap (0.25%) for six weeks']}, {'name': 'Placebo Comparator', 'type': 'DRUG', 'description': 'Vehicle Ophthalmic Solution administered for six weeks (QID for four weeks then BID for two weeks).', 'armGroupLabels': ['Vehicle for six weeks']}, {'name': 'Reproxalap Ophthalmic Solution (0.25%)', 'type': 'DRUG', 'description': 'Reproxalap Ophthalmic Solution (0.25%) administered for one year (QID for four weeks then BID for 11 months).', 'armGroupLabels': ['Reproxalap (0.25%) for 12 months']}, {'name': 'Placebo Comparator', 'type': 'DRUG', 'description': 'Vehicle Ophthalmic Solution administered for one year (QID for four weeks then BID for 11 months).', 'armGroupLabels': ['Vehicle for 12 months']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01810', 'city': 'Andover', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Andover Eye Associates', 'geoPoint': {'lat': 42.65843, 'lon': -71.137}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aldeyra Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}