Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 10:08 PM
Study NCT ID:
NCT04674358
Status:
COMPLETED
Last Update Posted:
2025-03-19
First Post:
2020-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The TRANQUILITY Trial: Clinical Trial to Assess the Efficacy and Safety in Subjects With Dry Eye Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}}}}, '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': '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 one week.', 'eventGroups': [{'id': 'EG000', 'title': 'Reproxalap Ophthalmic Solution (0.25%)', 'description': 'Reproxalap ophthalmic solution administered seven times over two consecutive days', 'otherNumAtRisk': 164, 'deathsNumAtRisk': 164, 'otherNumAffected': 118, 'seriousNumAtRisk': 164, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vehicle', 'description': 'Vehicle ophthalmic solution administered seven times over two consecutive days', 'otherNumAtRisk': 163, 'deathsNumAtRisk': 163, 'otherNumAffected': 2, 'seriousNumAtRisk': 163, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'General disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 118}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Conjunctival Redness Assessed Over 90 Minutes in the Dry Eye Chamber', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reproxalap Ophthalmic Solution (0.25%)', 'description': 'Reproxalap ophthalmic solution administered six times over two consecutive days'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'Vehicle ophthalmic solution administered six times over two consecutive days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.185', 'spread': '0.0233', 'groupId': 'OG000'}, {'value': '0.156', 'spread': '0.0229', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'The efficacy assessment period was assessed during the 90-minute dry eye chamber at Day 2; baseline was Pre-Dose #1 at Day 1.', 'description': 'Change from baseline comparison of reproxalap to vehicle for conjunctival redness on a 0 to 4 scale ( 0 = normal, 4 = prominent), where a high score means a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included baseline, site, treatment group, and nominal time point as fixed effects.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population with observed data only'}, {'type': 'SECONDARY', 'title': 'Schirmer Test Change From Baseline After the First Dose on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reproxalap Ophthalmic Solution (0.25%)', 'description': 'Reproxalap ophthalmic solution administered four times over one day'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'Vehicle ophthalmic solution administered four times over one day'}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '0.53', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'The efficacy assessment period was before and after the final dose on Day 1; baseline was Pre-Dose #1 at Day 1.', 'description': 'Change from baseline comparison of reproxalap to vehicle for Schirmer test on a millimeter line (0 = none, 35 = maximum), where a shorter length indicates a worse outcome. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included baseline and treatment group as fixed effects.', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population with observed data only'}, {'type': 'POST_HOC', 'title': 'Conjunctival Redness Assessed Over 90 Minutes in the Dry Eye Chamber Using Computer Automated Grading', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reproxalap Ophthalmic Solution (0.25%)', 'description': 'Reproxalap ophthalmic solution administered six times over two consecutive days'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'Vehicle ophthalmic solution administered six times over two consecutive days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.309', 'spread': '0.2160', 'groupId': 'OG000'}, {'value': '0.962', 'spread': '0.2121', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'The efficacy assessment period was assessed during the 90-minute dry eye chamber at Day 2; baseline was Pre-Dose #1 at Day 1.', 'description': 'Change from baseline comparison of reproxalap to vehicle for conjunctival redness on a 0 to 255 scale ( 0 = none, 255 = maximum), where a high score means a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included baseline, site, treatment group, and nominal time point as fixed effects.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population with observed data only'}, {'type': 'POST_HOC', 'title': 'Number of Subject Eyes That Are Schirmer Test Responders (Eyes 10 Millimeters or More Increase From Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '306', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reproxalap Ophthalmic Solution (0.25%)', 'description': 'Reproxalap ophthalmic solution administered four times over one day'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'Vehicle ophthalmic solution administered four times over one day'}], 'classes': [{'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.63', 'ciLowerLimit': '1.67', 'ciUpperLimit': '4.14', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Efficacy was assessed after a single dose on Day 1; baseline was assessed approximately two weeks before dosing.', 'description': 'The number of subject eyes that are schirmer test responders (eyes with 10 millimeters or more increase from baseline) using a millimeter line (0 = none, 35 = maximum), where a shorter length indicates a worse outcome.', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Intent-to-treat population with observed data only'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Reproxalap Ophthalmic Solution (0.25%)', 'description': 'Subjects randomized to reproxalap ophthalmic solution administered seven times over two consecutive days'}, {'id': 'FG001', 'title': 'Vehicle', 'description': 'Subjects randomized to vehicle ophthalmic solution administered seven times over two consecutive days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '164'}, {'groupId': 'FG001', 'numSubjects': '163'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}, {'groupId': 'FG001', 'numSubjects': '160'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'There were 331 randomized subjects, of which 329 were unique (23 in the initial exploratory cohort and 306 in the main cohort). Two subjects in the main cohort were randomized twice by accident and two subjects were randomized but not dosed, making the safety population 327 subjects. The Safety population is presented in the Participant Flow, Baseline Characteristics, and Adverse Events. Efficacy analysis was conducted on subjects in the main cohort (306 subjects, intent-to-treat population).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '327', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Reproxalap Ophthalmic Solution (0.25%)', 'description': 'Reproxalap ophthalmic solution administered seven times over two consecutive days'}, {'id': 'BG001', 'title': 'Vehicle', 'description': 'Vehicle ophthalmic solution administered seven times over two consecutive days'}, {'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': '87', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '238', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '154', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '305', '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': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '259', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Multiple', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '164', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '327', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Iris Color (Right Eye)', 'classes': [{'title': 'Black', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Blue', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}, {'title': 'Brown', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}]}, {'title': 'Hazel', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}, {'title': 'Green', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}, {'title': 'Gray', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Iris Color (Left Eye)', 'classes': [{'title': 'Black', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Blue', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}, {'title': 'Brown', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}]}, {'title': 'Hazel', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}, {'title': 'Green', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}, {'title': 'Gray', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-05', 'size': 869500, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-02-03T10:19', 'hasProtocol': True}, {'date': '2021-11-17', 'size': 497241, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-02-03T10:20', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 329}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2021-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-28', 'studyFirstSubmitDate': '2020-12-14', 'resultsFirstSubmitDate': '2023-02-03', 'studyFirstSubmitQcDate': '2020-12-17', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-28', 'studyFirstPostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Conjunctival Redness Assessed Over 90 Minutes in the Dry Eye Chamber', 'timeFrame': 'The efficacy assessment period was assessed during the 90-minute dry eye chamber at Day 2; baseline was Pre-Dose #1 at Day 1.', 'description': 'Change from baseline comparison of reproxalap to vehicle for conjunctival redness on a 0 to 4 scale ( 0 = normal, 4 = prominent), where a high score means a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included baseline, site, treatment group, and nominal time point as fixed effects.'}], 'secondaryOutcomes': [{'measure': 'Schirmer Test Change From Baseline After the First Dose on Day 1', 'timeFrame': 'The efficacy assessment period was before and after the final dose on Day 1; baseline was Pre-Dose #1 at Day 1.', 'description': 'Change from baseline comparison of reproxalap to vehicle for Schirmer test on a millimeter line (0 = none, 35 = maximum), where a shorter length indicates a worse outcome. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included baseline and treatment group as fixed effects.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['reproxalap', 'ADX-102', 'Tranquility'], 'conditions': ['Dry Eye', 'Dry Eye Syndromes']}, 'descriptionModule': {'briefSummary': 'The TRANQUILITY Trial: Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 2/3 Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle 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* Reported 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 use within 90 days of Visit 1;\n* Be receiving systemic corticosteroid therapy (not including inhaled corticosteroids) within 14 days of Visit 1 or anticipate such therapy throughout the study period;\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': 'NCT04674358', 'briefTitle': 'The TRANQUILITY Trial: Clinical Trial to Assess the Efficacy and Safety in Subjects With Dry Eye Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aldeyra Therapeutics, Inc.'}, 'officialTitle': 'The TRANQUILITY Trial: Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 2/3 Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease', 'orgStudyIdInfo': {'id': 'ADX-102-DED-019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reproxalap Ophthalmic Solution (0.25%) administered QID over two consecutive days.', 'interventionNames': ['Drug: Reproxalap Ophthalmic Solution (0.25%)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle Ophthalmic Solution administered over two consecutive days.', 'interventionNames': ['Drug: Vehicle Opthalmic Solution']}], 'interventions': [{'name': 'Reproxalap Ophthalmic Solution (0.25%)', 'type': 'DRUG', 'description': 'Reproxalap Ophthalmic Solution (0.25%) administered over two consecutive days (Day one pre-dry eye chamber and Day two dry eye chamber assessment).', 'armGroupLabels': ['Reproxalap Ophthalmic Solution (0.25%) administered QID over two consecutive days.']}, {'name': 'Vehicle Opthalmic Solution', 'type': 'DRUG', 'description': 'Vehicle Ophthalmic Solution administered over two consecutive days (Day one pre-dry eye chamber and Day two dry eye chamber assessment).', 'armGroupLabels': ['Vehicle Ophthalmic Solution administered over two consecutive days.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38103', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University Clinical Health', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aldeyra Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}