Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-25 @ 6:57 PM
Study NCT ID:
NCT03494504
Status:
COMPLETED
Last Update Posted:
2025-02-11
First Post:
2018-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
ALLEVIATE Trial - A Phase 3 Trial in Subjects With Allergic Conjunctivitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}}}}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bcavanagh@aldeyra.com', 'phone': '781-257-3063', 'title': 'Sr. Director, Clinical Operations', 'organization': 'Aldeyra Therapeutics, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The period of time over which adverse events were collected for each subject in the clinical trial was approximately two months.', 'eventGroups': [{'id': 'EG000', 'title': 'Reproxalap Ophthalmic Solution (0.25%)', 'description': 'Reproxalap administered once 10 minutes prior to pollen exposure', 'otherNumAtRisk': 109, 'deathsNumAtRisk': 109, 'otherNumAffected': 31, 'seriousNumAtRisk': 109, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Reproxalap Ophthalmic Solution (0.5%)', 'description': 'Reproxalap administered once 10 minutes prior to pollen exposure', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 41, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Vehicle Ophthalmic Solution', 'description': 'Vehicle administered once 10 minutes prior to pollen exposure', 'otherNumAtRisk': 109, 'deathsNumAtRisk': 109, 'otherNumAffected': 1, 'seriousNumAtRisk': 109, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'General disorders and administration site conditions', 'notes': 'Transient and self-limiting instillation site irritation that resolved in all cases. All adverse events were deemed mild in severity by the Principal Investigators.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subject-reported Ocular Itching Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Reproxalap Ophthalmic Solution (0.25%)', 'description': 'Reproxalap administered once 10 minutes prior to pollen exposure'}, {'id': 'OG001', 'title': 'Reproxalap Ophthalmic Solution (0.5%)', 'description': 'Reproxalap administered once 10 minutes prior to pollen exposure'}, {'id': 'OG002', 'title': 'Vehicle Ophthalmic Solution', 'description': 'Vehicle administered once 10 minutes prior to pollen exposure'}], 'classes': [{'categories': [{'measurements': [{'value': '52.003', 'spread': '3.3053', 'groupId': 'OG000'}, {'value': '60.040', 'spread': '3.4552', 'groupId': 'OG001'}, {'value': '74.657', 'spread': '3.3076', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Efficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing.', 'description': 'Subject-reported ocular itching score area under the curve from 10 to 60 minutes post allergen challenge using a 0 to 4 scale (0 = none, 4 = severe) was assessed. The least squares mean was derived from analysis of covariance of area under the curve with baseline as a covariate and treatment as a fixed effect The possible range for area under the curve least squares mean is 0 to 100, where a lower score is better.', 'unitOfMeasure': 'units on a scale*minutes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population with observed data only'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Two-point Reduction in Itching Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Reproxalap Ophthalmic Solution (0.25%)', 'description': 'Reproxalap administered once 10 minutes prior to pollen exposure'}, {'id': 'OG001', 'title': 'Reproxalap Ophthalmic Solution (0.5%)', 'description': 'Reproxalap administered once 10 minutes prior to pollen exposure'}, {'id': 'OG002', 'title': 'Vehicle Ophthalmic Solution', 'description': 'Vehicle administered once 10 minutes prior to pollen exposure'}], 'classes': [{'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.36', 'ciLowerLimit': '1.46', 'ciUpperLimit': '3.84', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.81', 'ciLowerLimit': '1.11', 'ciUpperLimit': '2.94', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Efficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing.', 'description': 'The number of within subject 2-point responders (2-point reduction in itch score from 20-60 minutes post-challenge) using a 0 to 4 scale (0 = least, 4 = most) from the 5-minute post-challenge itch score at baseline was assessed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population with observed data only'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Reproxalap Ophthalmic Solution (0.25%)', 'description': 'Reproxalap administered once 10 minutes prior to pollen exposure'}, {'id': 'FG001', 'title': 'Reproxalap Ophthalmic Solution (0.5%)', 'description': 'Reproxalap administered once 10 minutes prior to pollen exposure'}, {'id': 'FG002', 'title': 'Vehicle Ophthalmic Solution', 'description': 'Vehicle administered once 10 minutes prior to pollen exposure'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '100'}, {'groupId': 'FG002', 'numSubjects': '109'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '100'}, {'groupId': 'FG002', 'numSubjects': '109'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '318', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Reproxalap Ophthalmic Solution (0.25%)', 'description': 'Reproxalap administered once 10 minutes prior to pollen exposure'}, {'id': 'BG001', 'title': 'Reproxalap Ophthalmic Solution (0.5%)', 'description': 'Reproxalap administered once 10 minutes prior to pollen exposure'}, {'id': 'BG002', 'title': 'Vehicle Ophthalmic Solution', 'description': 'Vehicle administered once 10 minutes prior to pollen exposure'}, {'id': 'BG003', '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}, {'value': '282', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '197', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '121', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '272', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '232', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '318', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Iris Color (Right Eye)', 'classes': [{'title': 'Black', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Blue', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}]}]}, {'title': 'Brown', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '173', 'groupId': 'BG003'}]}]}, {'title': 'Hazel', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}]}, {'title': 'Green', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}, {'title': 'Gray', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Iris Color (Left Eye)', 'classes': [{'title': 'Black', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Blue', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}]}]}, {'title': 'Brown', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '173', 'groupId': 'BG003'}]}]}, {'title': 'Hazel', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}]}, {'title': 'Green', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}, {'title': 'Gray', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Randomization Stratum', 'classes': [{'title': '<= 2.7 Average Baseline Itching Score', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '121', 'groupId': 'BG003'}]}]}, {'title': '> 2.7 and <= 3.5 Average Baseline Itching Score', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}]}]}, {'title': '> 3.5 Average Baseline Itching Score', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Itching scale is 0 to 4 (0 = none, 4 = severe)', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-15', 'size': 10949577, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-03-02T12:10', 'hasProtocol': True}, {'date': '2019-02-20', 'size': 1339391, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-03-02T12:10', 'hasProtocol': False}]}}, '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': 318}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'dispFirstSubmitDate': '2019-10-30', 'completionDateStruct': {'date': '2018-11-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-21', 'studyFirstSubmitDate': '2018-04-04', 'resultsFirstSubmitDate': '2023-03-31', 'studyFirstSubmitQcDate': '2018-04-04', 'dispFirstPostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-21', 'studyFirstPostDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subject-reported Ocular Itching Score', 'timeFrame': 'Efficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing.', 'description': 'Subject-reported ocular itching score area under the curve from 10 to 60 minutes post allergen challenge using a 0 to 4 scale (0 = none, 4 = severe) was assessed. The least squares mean was derived from analysis of covariance of area under the curve with baseline as a covariate and treatment as a fixed effect The possible range for area under the curve least squares mean is 0 to 100, where a lower score is better.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With Two-point Reduction in Itching Score', 'timeFrame': 'Efficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing.', 'description': 'The number of within subject 2-point responders (2-point reduction in itch score from 20-60 minutes post-challenge) using a 0 to 4 scale (0 = least, 4 = most) from the 5-minute post-challenge itch score at baseline was assessed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['reproxalap'], 'conditions': ['Allergic Conjunctivitis']}, 'descriptionModule': {'briefSummary': 'A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solutions in Subjects with Acute Allergic Conjunctivitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* be at least 18 years of age of either gender and any race\n* have a positive history of ocular allergies and a positive skin test reaction to a seasonal allergen (grasses, ragweed, and/or trees) as confirmed by an allergic skin test at the Screening Visit or within the past 24 months;\n* have a calculated visual acuity of 0.7 logMAR or better in each eye as measured using an ETDRS chart\n\nExclusion Criteria:\n\n* have known contraindications or sensitivities to the use of the investigational product or any of its components\n* have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium or a diagnosis of dry eye)\n* have had ocular surgical intervention within three (3) months prior to Visit 1 or during the trial and/or a history of refractive surgery six (6) months prior to Visit 1 or have ocular or systemic surgery planned during the study or within 30 days after\n* have a known history of retinal detachment, diabetic retinopathy, or active retinal disease\n* have the presence of an active ocular infection (bacterial, viral or fungal) or positive history of an ocular herpetic infection at any visit\n* be a female who is currently pregnant, planning a pregnancy, lactating, not using a medically acceptable form of birth control throughout the trial duration, or has a positive urine pregnancy test at Visit 1"}, 'identificationModule': {'nctId': 'NCT03494504', 'briefTitle': 'ALLEVIATE Trial - A Phase 3 Trial in Subjects With Allergic Conjunctivitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aldeyra Therapeutics, Inc.'}, 'officialTitle': 'A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Phase 3 Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solutions (0.25% and 0.5%) Compared to Vehicle in the Conjunctival Allergen Challenge (Ora-CAC®) Model of Acute Allergic Conjunctivitis', 'orgStudyIdInfo': {'id': 'ADX-102-AC-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reproxalap Ophthalmic Solution (0.25%)', 'interventionNames': ['Drug: Reproxalap Ophthalmic Solution (0.25%)']}, {'type': 'EXPERIMENTAL', 'label': 'Reproxalap Ophthalmic Solution (0.5%)', 'interventionNames': ['Drug: Reproxalap Ophthalmic Solution (0.5%)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle Ophthalmic Solution', 'interventionNames': ['Drug: Vehicle Ophthalmic Solution']}], 'interventions': [{'name': 'Reproxalap Ophthalmic Solution (0.25%)', 'type': 'DRUG', 'description': 'Reproxalap Ophthalmic Solution (0.25%) administered once.', 'armGroupLabels': ['Reproxalap Ophthalmic Solution (0.25%)']}, {'name': 'Reproxalap Ophthalmic Solution (0.5%)', 'type': 'DRUG', 'description': 'Reproxalap Ophthalmic Solution (0.5%) administered once.', 'armGroupLabels': ['Reproxalap Ophthalmic Solution (0.5%)']}, {'name': 'Vehicle Ophthalmic Solution', 'type': 'DRUG', 'description': 'Vehicle Ophthalmic Solution administered once.', 'armGroupLabels': ['Vehicle Ophthalmic Solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Cornea Consultants of Arizon', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '95819', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Eye Site Sacramento', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'East West Eye Institute', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '21078', 'city': 'Havre de Grace', 'state': 'Maryland', 'country': 'United States', 'facility': 'Seidenberg Protzko Eye Associates', 'geoPoint': {'lat': 39.54928, 'lon': -76.09162}}, {'zip': '01810', 'city': 'Andover', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Andover Eye Associates', 'geoPoint': {'lat': 42.65843, 'lon': -71.137}}, {'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Eye Clinics of South Texas', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'R & R Research, LLC', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aldeyra Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}