Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2025-12-27 @ 2:36 AM
Study NCT ID:
NCT05360966
Status:
COMPLETED
Last Update Posted:
2025-07-23
First Post:
2022-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Evaluating the Safety and Efficacy of AR-15512 (COMET-3)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-06-22', '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': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'Scientific Advisor, Clinical Research and Development', 'organization': 'Alcon Research, LLC'}, 'certainAgreement': {'otherDetails': 'Sponsor reserves the right of prior review of any publication or presentation of information related to the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': "An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.", 'description': 'All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.', 'eventGroups': [{'id': 'EG000', 'title': 'Pretreatment', 'description': 'AEs reported in this group occurred prior to treatment with the study drug and include the 2-week vehicle run-in.', 'otherNumAtRisk': 466, 'deathsNumAtRisk': 466, 'otherNumAffected': 5, 'seriousNumAtRisk': 466, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '0.003% AR-15512 Ocular', 'description': 'AEs reported in this group occurred during the 0.003% AR-15512 ophthalmic solution treatment period.', 'otherNumAtRisk': 232, 'deathsNumAtRisk': 0, 'otherNumAffected': 118, 'seriousNumAtRisk': 232, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '0.003% AR-15512 Nonocular', 'description': 'AEs reported in this group occurred during the 0.003% AR-15512 ophthalmic solution treatment period.', 'otherNumAtRisk': 232, 'deathsNumAtRisk': 232, 'otherNumAffected': 0, 'seriousNumAtRisk': 232, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'AR-15512 Vehicle Ocular', 'description': 'AEs reported in this group occurred during the AR-15512 vehicle ophthalmic solution treatment period.', 'otherNumAtRisk': 234, 'deathsNumAtRisk': 0, 'otherNumAffected': 7, 'seriousNumAtRisk': 234, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'AR-15512 Vehicle Nonocular', 'description': 'AEs reported in this group occurred during the AR-15512 vehicle ophthalmic solution treatment period.', 'otherNumAtRisk': 234, 'deathsNumAtRisk': 234, 'otherNumAffected': 0, 'seriousNumAtRisk': 234, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Instillation site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 124, 'numAffected': 118}, {'groupId': 'EG002', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 234, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Metabolic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects Who Achieved Equal to or Greater Than 10 Millimeter Increase From Pre-drop at Baseline to Post-drop on Day 14 in Study Eye Unanesthetized Schirmer Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.003% AR-15512', 'description': '0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 90 days'}, {'id': 'OG001', 'title': 'AR-15512 Vehicle', 'description': 'AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 90 days'}], 'classes': [{'categories': [{'measurements': [{'value': '53.2', 'groupId': 'OG000'}, {'value': '14.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '38.8', 'ciLowerLimit': '30.8', 'ciUpperLimit': '46.8', 'pValueComment': 'Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.', 'estimateComment': 'Difference equals 0.003% AR-15512 minus AR-15512 Vehicle', 'groupDescription': 'The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.', 'statisticalMethod': "Pearson's Chi-squared test", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference (2-sided)', 'otherAnalysisDescription': 'For binary endpoint, the underlying continuous measurement of unanesthetized Schirmer score was imputed, change score calculated and then dichotomized to ascertain attainment of greater than or equal to 10 millimeter increase from pre-drop baseline.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) pre-drop; Day 14 post-drop', 'description': 'The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 14 following drop exposure. An increased score represents a positive outcome. One eye (study eye) contributed data to the analysis.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology.'}, {'type': 'SECONDARY', 'title': 'Least Squares Mean Change From Baseline in Global Symptom Assessment iN Dry Eye (SANDE) Score on Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.003% AR-15512', 'description': '0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 90 days'}, {'id': 'OG001', 'title': 'AR-15512 Vehicle', 'description': 'AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 90 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-22.3', 'spread': '1.66', 'groupId': 'OG000'}, {'value': '-19.1', 'spread': '1.64', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1321', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.1', 'ciLowerLimit': '-7.2', 'ciUpperLimit': '0.9', 'pValueComment': 'Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.08', 'estimateComment': 'Difference equals 0.003% AR-15512 minus AR-15512 Vehicle', 'groupDescription': 'The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center.', 'nonInferiorityComment': 'Difference (2-sided)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1); Day 28', 'description': 'The SANDE questionnaire assesses the frequency and severity of symptoms using 2 unique, 100 mm Visual Analog Scales to mark the frequency (0=rarely, 100=all the time) and severity (0=very mild, 100=very severe) of dry eye symptoms (prior to drop exposure). The 2 scores were multiplied and a square root was obtained for a resultant overall Global SANDE score of 0 to 100 where 0 represents no symptoms and 100 is maximum symptoms. A negative change indicates a better outcome. This was a subject based assessment (single score for both eyes).', 'unitOfMeasure': 'millimeter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology.'}, {'type': 'SECONDARY', 'title': 'Least Squares Mean Change From Pre-drop Baseline Unanesthetized Schirmer Score on Post-drop Day 14 (Study Eye)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.003% AR-15512', 'description': '0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 90 days'}, {'id': 'OG001', 'title': 'AR-15512 Vehicle', 'description': 'AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 90 days'}], 'classes': [{'categories': [{'measurements': [{'value': '10.9', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '0.59', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.3', 'ciLowerLimit': '6.9', 'ciUpperLimit': '9.8', 'pValueComment': 'Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.75', 'estimateComment': 'Difference equals 0.003% AR-15512 minus AR-15512 Vehicle', 'groupDescription': 'The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center', 'nonInferiorityComment': 'Difference (2-sided)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) pre-drop; Day 14 post-drop', 'description': 'The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 14 following drop exposure. The Day 14 post-drop value was compared to the Day 1 pre-drop value. A positive change indicates a better outcome. One eye (study eye) contributed data to the analysis.', 'unitOfMeasure': 'millimeter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Who Achieved Equal to or Greater Than 10 Millimeter Increase From Pre-drop at Baseline to Post-drop on Day 1 in Study Eye Unanesthetized Schirmer Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.003% AR-15512', 'description': '0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 90 days'}, {'id': 'OG001', 'title': 'AR-15512 Vehicle', 'description': 'AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 90 days'}], 'classes': [{'categories': [{'measurements': [{'value': '53.7', 'groupId': 'OG000'}, {'value': '13.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '40.1', 'ciLowerLimit': '32.3', 'ciUpperLimit': '47.9', 'pValueComment': 'Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.', 'estimateComment': 'Difference equals 0.003% AR-15512 minus AR-15512 Vehicle', 'groupDescription': 'The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.', 'statisticalMethod': "Pearson's Chi-squared test", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference (2-sided)', 'otherAnalysisDescription': 'For binary endpoint, the underlying continuous measurement of unanesthetized Schirmer score was imputed, change score calculated and then dichotomized to ascertain attainment of greater than or equal to 10 millimeter increase from pre-drop baseline.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) pre-drop; Day 1 post-drop', 'description': 'The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at each subsequent study visit. The study visit value was compared to the Day 1 pre-drop value. A positive change indicates a better outcome. One eye (study eye) contributed data to the analysis.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology.'}, {'type': 'SECONDARY', 'title': 'Least Squares Mean Change From Pre-drop Baseline in Unanesthetized Schirmer Score on Post-drop Day 1 (Study Eye)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.003% AR-15512', 'description': '0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 90 days'}, {'id': 'OG001', 'title': 'AR-15512 Vehicle', 'description': 'AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 90 days'}], 'classes': [{'categories': [{'measurements': [{'value': '10.9', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '0.53', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.6', 'ciLowerLimit': '6.3', 'ciUpperLimit': '8.9', 'pValueComment': 'Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.67', 'estimateComment': 'Difference equals 0.003% AR-15512 minus AR-15512 Vehicle', 'groupDescription': 'The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center', 'nonInferiorityComment': 'Difference (2-sided)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) pre-drop; Day 1 post-drop', 'description': 'The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 1 following drop exposure. The Day 1 post-drop score was compared to the Day 1 pre-drop score. A positive change over time indicates a better outcome. One eye (study eye) contributed data to the analysis.', 'unitOfMeasure': 'millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Who Achieved Equal to or Greater Than 10 Millimeter Increase From Pre-drop at Baseline to Post-drop on Day 90 in Study Eye Unanesthetized Schirmer Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.003% AR-15512', 'description': '0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 90 days'}, {'id': 'OG001', 'title': 'AR-15512 Vehicle', 'description': 'AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 90 days'}], 'classes': [{'categories': [{'measurements': [{'value': '59.2', 'groupId': 'OG000'}, {'value': '21.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '37.3', 'ciLowerLimit': '28.7', 'ciUpperLimit': '45.9', 'pValueComment': 'Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.', 'estimateComment': 'Difference equals 0.003% AR-15512 minus AR-15512 Vehicle', 'groupDescription': 'The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.', 'statisticalMethod': "Pearson's Chi-squared test", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference (2 sided)', 'otherAnalysisDescription': 'For binary endpoint, the underlying continuous measurement of unanesthetized Schirmer score was imputed, change score calculated and then dichotomized to ascertain attainment of greater than or equal to 10 millimeter increase from pre-drop baseline.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) pre-drop; Day 90 post-drop', 'description': 'The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 90 following drop exposure. The Day 90 post-drop score was compared to the Day 1 pre-drop score. An increased score represents a positive outcome. One eye (study eye) contributed data to the analysis.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology.'}, {'type': 'SECONDARY', 'title': 'Least Squares Mean Change From Pre-drop Baseline in Unanesthetized Schirmer Score on Post-drop Day 90 (Study Eye)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.003% AR-15512', 'description': '0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 90 days'}, {'id': 'OG001', 'title': 'AR-15512 Vehicle', 'description': 'AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 90 days'}], 'classes': [{'categories': [{'measurements': [{'value': '11.7', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '0.61', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.1', 'ciLowerLimit': '6.5', 'ciUpperLimit': '9.6', 'pValueComment': 'Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.78', 'estimateComment': 'Difference equals 0.003% AR-15512 minus AR-15512 Vehicle', 'groupDescription': 'The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center', 'nonInferiorityComment': 'Difference (2-sided)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) pre-drop; Day 90 post-drop', 'description': 'The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 90 following drop exposure. The Day 90 post-drop score was compared to the Day 1 pre-drop score. A positive change over time indicates a better outcome. One eye (study eye) contributed data to the analysis.', 'unitOfMeasure': 'millimeter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology.'}, {'type': 'SECONDARY', 'title': 'Least Squares Mean Change From Baseline in Global SANDE Score on Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.003% AR-15512', 'description': '0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 90 days'}, {'id': 'OG001', 'title': 'AR-15512 Vehicle', 'description': 'AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 90 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-28.3', 'spread': '1.92', 'groupId': 'OG000'}, {'value': '-26.9', 'spread': '1.88', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5626', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-6.1', 'ciUpperLimit': '3.3', 'pValueComment': 'Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.40', 'estimateComment': 'Difference equals 0.003% AR-15512 minus AR-15512 Vehicle', 'groupDescription': 'The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center', 'nonInferiorityComment': 'Difference (2-sided)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1); Day 90', 'description': 'The SANDE questionnaire assesses the frequency and severity of symptoms using 2 unique, 100 mm Visual Analog Scales to mark the frequency (0=rarely, 100=all the time) and severity (0=very mild, 100=very severe) of dry eye symptoms (prior to drop exposure). The 2 scores were multiplied and a square root was obtained for a resultant overall Global SANDE score of 0 to 100 where 0 represents no symptoms and 100 is maximum symptoms. A negative change indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.', 'unitOfMeasure': 'millimeter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology.'}, {'type': 'SECONDARY', 'title': 'Least Squares Mean Change From Baseline in SANDE Frequency Score on Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.003% AR-15512', 'description': '0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 90 days'}, {'id': 'OG001', 'title': 'AR-15512 Vehicle', 'description': 'AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 90 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-28.6', 'spread': '2.03', 'groupId': 'OG000'}, {'value': '-27.2', 'spread': '2.00', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5981', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-6.3', 'ciUpperLimit': '3.6', 'pValueComment': 'Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.53', 'estimateComment': 'Difference equals 0.003% AR-15512 minus AR-15512 Vehicle', 'groupDescription': 'The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center', 'nonInferiorityComment': 'Difference (2-sided)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1); Day 90', 'description': 'The SANDE questionnaire assesses the frequency of dry eye disease symptoms. Subjects used a 100 mm Visual Analog Scale (VAS) to mark the frequency of symptoms where 0=rarely and 100=all the time. A higher SANDE frequency score indicates greater symptoms of dryness and/or irritation. The questionnaire was completed at Day 1 and Day 90 prior to drop exposure (both visits). The Day 90 value was compared to the Day 1 value. A negative change indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.', 'unitOfMeasure': 'millimeter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology.'}, {'type': 'SECONDARY', 'title': 'Least Squares Mean Change From Baseline in SANDE Severity Score on Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.003% AR-15512', 'description': '0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 90 days'}, {'id': 'OG001', 'title': 'AR-15512 Vehicle', 'description': 'AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 90 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-27.0', 'spread': '1.95', 'groupId': 'OG000'}, {'value': '-25.4', 'spread': '1.91', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5161', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-6.4', 'ciUpperLimit': '3.2', 'pValueComment': 'Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.44', 'estimateComment': 'Difference equals 0.003% AR-15512 minus AR-15512 Vehicle', 'groupDescription': 'The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center', 'nonInferiorityComment': 'Difference (2-sided)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1); Day 90', 'description': 'The SANDE questionnaire assesses the severity of dry eye disease symptoms. Subjects used a 100 mm Visual Analog Scale (VAS) to mark the severity of symptoms where 0=very mild and 100=very severe. A higher SANDE severity score indicates greater symptoms of dryness and/or irritation. The questionnaire was completed at Day 1 and Day 90 prior to drop exposure (both visits). The Day 90 value was compared to the Day 1 value. A negative change indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.', 'unitOfMeasure': 'millimeter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology.'}, {'type': 'SECONDARY', 'title': 'Least Squares Mean Change From Baseline in Eye Dryness Score (EDS) on Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.003% AR-15512', 'description': '0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 90 days'}, {'id': 'OG001', 'title': 'AR-15512 Vehicle', 'description': 'AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 90 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-22.4', 'spread': '1.98', 'groupId': 'OG000'}, {'value': '-22.8', 'spread': '1.97', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8574', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-4.5', 'ciUpperLimit': '5.4', 'pValueComment': 'Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.51', 'estimateComment': 'Difference equals 0.003% AR-15512 minus AR-15512 Vehicle', 'groupDescription': 'The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center', 'nonInferiorityComment': 'Difference (2-sided)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1); Day 90', 'description': 'The subject used a 100 mm Visual Analog Scale (VAS) to mark their eye dryness, where 0=no eye dryness and 100=maximum eye dryness. Eye dryness was assessed at Day 1 and Day 90 prior to drop exposure (both visits). A higher eye dryness score indicates greater dryness. The Day 90 value was compared to the Day 1 value. A negative change indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.', 'unitOfMeasure': 'millimeter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology.'}, {'type': 'SECONDARY', 'title': 'Least Squares Mean Change From Baseline in Ocular Discomfort Score (ODS) on Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.003% AR-15512', 'description': '0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 90 days'}, {'id': 'OG001', 'title': 'AR-15512 Vehicle', 'description': 'AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 90 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-35.0', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '-34.0', 'spread': '2.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6980', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-6.3', 'ciUpperLimit': '4.2', 'pValueComment': 'Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.69', 'estimateComment': 'Difference equals 0.003% AR-15512 minus AR-15512 Vehicle', 'groupDescription': 'The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center', 'nonInferiorityComment': 'Difference (2-sided)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1); Day 90', 'description': 'The subject used a 100 mm Visual Analog Scale (VAS) to mark their eye dryness, where 0=no ocular discomfort and 100 mm=maximum ocular discomfort. A higher ocular discomfort score indicates greater discomfort. Ocular discomfort was assessed at Day 1 and Day 90 prior to drop exposure (both visits). The Day 90 value was compared to the Day 1 value. A negative change indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.', 'unitOfMeasure': 'millimeter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '0.003% AR-15512', 'description': '0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 90 days'}, {'id': 'FG001', 'title': 'AR-15512 Vehicle', 'description': 'AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 90 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '232'}, {'groupId': 'FG001', 'numSubjects': '235'}]}, {'type': 'Intent to Treat (ITT) Population', 'comment': 'One subject randomized to AR-15512 Vehicle was excluded from the ITT population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '232'}, {'groupId': 'FG001', 'numSubjects': '234'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '232'}, {'groupId': 'FG001', 'numSubjects': '234'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '215'}, {'groupId': 'FG001', 'numSubjects': '219'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrawal of Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'As specified in the Clinical Study Report', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Participants were recruited from 23 investigative sites located in the United States.', 'preAssignmentDetails': 'This reporting group includes all randomized participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'BG000'}, {'value': '234', 'groupId': 'BG001'}, {'value': '466', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '0.003% AR-15512', 'description': '0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 90 days'}, {'id': 'BG001', 'title': 'AR-15512 Vehicle', 'description': 'AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 90 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.1', 'spread': '12.23', 'groupId': 'BG000'}, {'value': '62.1', 'spread': '12.19', 'groupId': 'BG001'}, {'value': '62.6', 'spread': '12.21', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '177', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '343', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '216', 'groupId': 'BG000'}, {'value': '206', 'groupId': 'BG001'}, {'value': '422', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian / Alaska Native', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}, {'title': 'Black / African American', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '174', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '360', 'groupId': 'BG002'}]}]}, {'title': 'Multi-racial', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '232', 'groupId': 'BG000'}, {'value': '234', 'groupId': 'BG001'}, {'value': '466', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Unanesthetized Schirmer Test Pre- Drop at Baseline (Day 1)', 'classes': [{'categories': [{'measurements': [{'value': '6.8', 'spread': '6.28', 'groupId': 'BG000'}, {'value': '6.4', 'spread': '5.47', 'groupId': 'BG001'}, {'value': '6.6', 'spread': '5.88', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'millimeter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Global SANDE Score at Baseline (Day 1)', 'classes': [{'categories': [{'measurements': [{'value': '73.4', 'spread': '11.99', 'groupId': 'BG000'}, {'value': '73.9', 'spread': '12.65', 'groupId': 'BG001'}, {'value': '73.6', 'spread': '12.32', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'millimeter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'SANDE Frequency Score at Baseline (Day 1)', 'classes': [{'categories': [{'measurements': [{'value': '76.6', 'spread': '13.98', 'groupId': 'BG000'}, {'value': '76.8', 'spread': '14.13', 'groupId': 'BG001'}, {'value': '76.7', 'spread': '14.04', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'millimeter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'SANDE Severity Score at Baseline (Day 1)', 'classes': [{'categories': [{'measurements': [{'value': '71.2', 'spread': '13.59', 'groupId': 'BG000'}, {'value': '71.8', 'spread': '13.94', 'groupId': 'BG001'}, {'value': '71.5', 'spread': '13.76', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'millimeter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Eye Dryness Score at Baseline (Day 1)', 'classes': [{'categories': [{'measurements': [{'value': '71.6', 'spread': '14.32', 'groupId': 'BG000'}, {'value': '70.6', 'spread': '17.69', 'groupId': 'BG001'}, {'value': '71.1', 'spread': '16.09', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'millimeter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Ocular Discomfort Score at Baseline (Day 1)', 'classes': [{'categories': [{'measurements': [{'value': '74.5', 'spread': '12.64', 'groupId': 'BG000'}, {'value': '73.2', 'spread': '13.34', 'groupId': 'BG001'}, {'value': '73.9', 'spread': '13.00', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'millimeter', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'ITT Population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-04', 'size': 1200174, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-03-26T11:19', 'hasProtocol': True}, {'date': '2023-10-27', 'size': 2536358, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-02-17T10:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Qualified subjects will be enrolled in the study and randomized in a 1:1 ratio within each site to receive 0.003% AR 15512 or AR-15512 vehicle to be administered twice daily (BID) as 1 drop in each eye for 90 days.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 467}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'dispFirstSubmitDate': '2024-09-24', 'completionDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-22', 'studyFirstSubmitDate': '2022-05-02', 'resultsFirstSubmitDate': '2025-06-02', 'studyFirstSubmitQcDate': '2022-05-02', 'dispFirstPostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-22', 'studyFirstPostDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects Who Achieved Equal to or Greater Than 10 Millimeter Increase From Pre-drop at Baseline to Post-drop on Day 14 in Study Eye Unanesthetized Schirmer Score', 'timeFrame': 'Baseline (Day 1) pre-drop; Day 14 post-drop', 'description': 'The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 14 following drop exposure. An increased score represents a positive outcome. One eye (study eye) contributed data to the analysis.'}], 'secondaryOutcomes': [{'measure': 'Least Squares Mean Change From Baseline in Global Symptom Assessment iN Dry Eye (SANDE) Score on Day 28', 'timeFrame': 'Baseline (Day 1); Day 28', 'description': 'The SANDE questionnaire assesses the frequency and severity of symptoms using 2 unique, 100 mm Visual Analog Scales to mark the frequency (0=rarely, 100=all the time) and severity (0=very mild, 100=very severe) of dry eye symptoms (prior to drop exposure). The 2 scores were multiplied and a square root was obtained for a resultant overall Global SANDE score of 0 to 100 where 0 represents no symptoms and 100 is maximum symptoms. A negative change indicates a better outcome. This was a subject based assessment (single score for both eyes).'}, {'measure': 'Least Squares Mean Change From Pre-drop Baseline Unanesthetized Schirmer Score on Post-drop Day 14 (Study Eye)', 'timeFrame': 'Baseline (Day 1) pre-drop; Day 14 post-drop', 'description': 'The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 14 following drop exposure. The Day 14 post-drop value was compared to the Day 1 pre-drop value. A positive change indicates a better outcome. One eye (study eye) contributed data to the analysis.'}, {'measure': 'Percentage of Subjects Who Achieved Equal to or Greater Than 10 Millimeter Increase From Pre-drop at Baseline to Post-drop on Day 1 in Study Eye Unanesthetized Schirmer Score', 'timeFrame': 'Baseline (Day 1) pre-drop; Day 1 post-drop', 'description': 'The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at each subsequent study visit. The study visit value was compared to the Day 1 pre-drop value. A positive change indicates a better outcome. One eye (study eye) contributed data to the analysis.'}, {'measure': 'Least Squares Mean Change From Pre-drop Baseline in Unanesthetized Schirmer Score on Post-drop Day 1 (Study Eye)', 'timeFrame': 'Baseline (Day 1) pre-drop; Day 1 post-drop', 'description': 'The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 1 following drop exposure. The Day 1 post-drop score was compared to the Day 1 pre-drop score. A positive change over time indicates a better outcome. One eye (study eye) contributed data to the analysis.'}, {'measure': 'Percentage of Subjects Who Achieved Equal to or Greater Than 10 Millimeter Increase From Pre-drop at Baseline to Post-drop on Day 90 in Study Eye Unanesthetized Schirmer Score', 'timeFrame': 'Baseline (Day 1) pre-drop; Day 90 post-drop', 'description': 'The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 90 following drop exposure. The Day 90 post-drop score was compared to the Day 1 pre-drop score. An increased score represents a positive outcome. One eye (study eye) contributed data to the analysis.'}, {'measure': 'Least Squares Mean Change From Pre-drop Baseline in Unanesthetized Schirmer Score on Post-drop Day 90 (Study Eye)', 'timeFrame': 'Baseline (Day 1) pre-drop; Day 90 post-drop', 'description': 'The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 90 following drop exposure. The Day 90 post-drop score was compared to the Day 1 pre-drop score. A positive change over time indicates a better outcome. One eye (study eye) contributed data to the analysis.'}, {'measure': 'Least Squares Mean Change From Baseline in Global SANDE Score on Day 90', 'timeFrame': 'Baseline (Day 1); Day 90', 'description': 'The SANDE questionnaire assesses the frequency and severity of symptoms using 2 unique, 100 mm Visual Analog Scales to mark the frequency (0=rarely, 100=all the time) and severity (0=very mild, 100=very severe) of dry eye symptoms (prior to drop exposure). The 2 scores were multiplied and a square root was obtained for a resultant overall Global SANDE score of 0 to 100 where 0 represents no symptoms and 100 is maximum symptoms. A negative change indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.'}, {'measure': 'Least Squares Mean Change From Baseline in SANDE Frequency Score on Day 90', 'timeFrame': 'Baseline (Day 1); Day 90', 'description': 'The SANDE questionnaire assesses the frequency of dry eye disease symptoms. Subjects used a 100 mm Visual Analog Scale (VAS) to mark the frequency of symptoms where 0=rarely and 100=all the time. A higher SANDE frequency score indicates greater symptoms of dryness and/or irritation. The questionnaire was completed at Day 1 and Day 90 prior to drop exposure (both visits). The Day 90 value was compared to the Day 1 value. A negative change indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.'}, {'measure': 'Least Squares Mean Change From Baseline in SANDE Severity Score on Day 90', 'timeFrame': 'Baseline (Day 1); Day 90', 'description': 'The SANDE questionnaire assesses the severity of dry eye disease symptoms. Subjects used a 100 mm Visual Analog Scale (VAS) to mark the severity of symptoms where 0=very mild and 100=very severe. A higher SANDE severity score indicates greater symptoms of dryness and/or irritation. The questionnaire was completed at Day 1 and Day 90 prior to drop exposure (both visits). The Day 90 value was compared to the Day 1 value. A negative change indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.'}, {'measure': 'Least Squares Mean Change From Baseline in Eye Dryness Score (EDS) on Day 90', 'timeFrame': 'Baseline (Day 1); Day 90', 'description': 'The subject used a 100 mm Visual Analog Scale (VAS) to mark their eye dryness, where 0=no eye dryness and 100=maximum eye dryness. Eye dryness was assessed at Day 1 and Day 90 prior to drop exposure (both visits). A higher eye dryness score indicates greater dryness. The Day 90 value was compared to the Day 1 value. A negative change indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.'}, {'measure': 'Least Squares Mean Change From Baseline in Ocular Discomfort Score (ODS) on Day 90', 'timeFrame': 'Baseline (Day 1); Day 90', 'description': 'The subject used a 100 mm Visual Analog Scale (VAS) to mark their eye dryness, where 0=no ocular discomfort and 100 mm=maximum ocular discomfort. A higher ocular discomfort score indicates greater discomfort. Ocular discomfort was assessed at Day 1 and Day 90 prior to drop exposure (both visits). The Day 90 value was compared to the Day 1 value. A negative change indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye Disease']}, 'referencesModule': {'references': [{'pmid': '41038456', 'type': 'DERIVED', 'citation': 'Pattar GR, Wirta D, Jerkins G, Paauw J, McLaurin EB, Liu A, Evans DG, Kenyon K, Cline N, Gupta PK, Meng I, Senchyna M; COMET-2 and COMET-3 Study Groups. Acoltremon Ophthalmic Solution 0.003% for Signs and Symptoms of Dry Eye Disease: Results of Phase 3 Pivotal COMET-2 and COMET-3 Studies. Ophthalmology. 2025 Sep 30:S0161-6420(25)00605-0. doi: 10.1016/j.ophtha.2025.09.018. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'This will be a Phase 3, multicenter, vehicle-controlled, double-masked, randomized study conducted at approximately 20 sites in the United States. All subjects enrolled will have dry eye disease (DED). The study will consist of Screening (Day -14) and Baseline (Day 1) visits as well as visits at Day 7, Day 14, Day 28, and Day 90 (Study Exit) for an individual duration of participation of approximately 15 weeks.', 'detailedDescription': 'At the end of the Screening Visit, all qualified subjects will be assigned to administer one drop of AR-15512 Vehicle twice a day to both eyes for approximately 14 days (vehicle run-in period). After the vehicle run-in period, subjects will be re-evaluated for signs and symptoms of Dry Eye Disease (DED). Subjects who requalify based on inclusion/exclusion criteria will be enrolled in the study and randomized in a 1:1 ratio to receive 0.003% AR-15512 or AR-15512 Vehicle administered as 1 drop in each eye twice a day for 90 days. At the end of the Day 90 visit, subjects will exit the study.\n\nAerie Pharmaceuticals was acquired by Alcon on November 22, 2022.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Signs and symptoms of dry eye disease (DED) at the Screening and Baseline visits;\n* Corrected visual acuity of +0.70 logarithm Minimum angle of resolution (LogMAR) or better in both eyes at Screening and Baseline visits;\n* Other protocol-specified inclusion criteria may apply.\n\nKey Exclusion Criteria:\n\n* History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, likely interfere with the interpretation of the study results or subject safety;\n* Regular use of lid hygiene within 14 days prior to the Screening visit or any planned use during the study;\n* Use of artificial tears within 2 hours prior to the Screening visit or anticipated use during the study;\n* Medication use as specified in the protocol;\n* History or presence of significant systemic disease;\n* Other protocol-specified exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT05360966', 'briefTitle': 'Study Evaluating the Safety and Efficacy of AR-15512 (COMET-3)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aerie Pharmaceuticals'}, 'officialTitle': 'A Phase 3 Study Evaluating the Safety and Efficacy of AR-15512, a Cold Thermoreceptor Modulator, for the Treatment of Dry Eye Disease (COMET-3)', 'orgStudyIdInfo': {'id': 'AR-15512-CS302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0.003% AR-15512', 'description': '0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 90 days', 'interventionNames': ['Drug: 0.003% AR-15512 ophthalmic solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'AR-15512 Vehicle', 'description': 'AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 90 days', 'interventionNames': ['Drug: AR-15512 vehicle ophthalmic solution']}], 'interventions': [{'name': '0.003% AR-15512 ophthalmic solution', 'type': 'DRUG', 'description': 'Administered via topical ocular instillation', 'armGroupLabels': ['0.003% AR-15512']}, {'name': 'AR-15512 vehicle ophthalmic solution', 'type': 'DRUG', 'description': 'Inactive ingredients administered via topical ocular instillation', 'armGroupLabels': ['AR-15512 Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95926', 'city': 'Chico', 'state': 'California', 'country': 'United States', 'facility': 'Reeve Woods Eye Center', 'geoPoint': {'lat': 39.72849, 'lon': -121.83748}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'NVision Clinical Research, LLC', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Eye Research Foundation', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '91325', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'Shultz Vision', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'NVision Clinical Research, LLC', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '33904', 'city': 'Cape Coral', 'state': 'Florida', 'country': 'United States', 'facility': 'Argus Research Center', 'geoPoint': {'lat': 26.56285, 'lon': -81.94953}}, {'zip': '60046', 'city': 'Lake Villa', 'state': 'Illinois', 'country': 'United States', 'facility': 'Jackson Eye', 'geoPoint': {'lat': 42.41697, 'lon': -88.07397}}, {'zip': '60062', 'city': 'Northbrook', 'state': 'Illinois', 'country': 'United States', 'facility': 'Wyse Eyecare', 'geoPoint': {'lat': 42.12753, 'lon': -87.82895}}, {'zip': '47203', 'city': 'Columbus', 'state': 'Indiana', 'country': 'United States', 'facility': 'Pankratz Eye Institute', 'geoPoint': {'lat': 39.20144, 'lon': -85.92138}}, {'zip': '01810', 'city': 'Andover', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Andover Eye Associates', 'geoPoint': {'lat': 42.65843, 'lon': -71.137}}, {'zip': '01757', 'city': 'Milford', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Vision', 'geoPoint': {'lat': 42.13982, 'lon': -71.51617}}, {'zip': '02767', 'city': 'Raynham', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Andover Eye Associates - Raynham', 'geoPoint': {'lat': 41.94871, 'lon': -71.0731}}, {'zip': '89123', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'AdvanceMed Clinical Research', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '14624', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'NVision Clinical Research, LLC', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27529', 'city': 'Garner', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Oculus Research', 'geoPoint': {'lat': 35.71126, 'lon': -78.61417}}, {'zip': '28451', 'city': 'Leland', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wilmington Eye', 'geoPoint': {'lat': 34.25628, 'lon': -78.04471}}, {'zip': '28227', 'city': 'Mint Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pure Ophthalmic Research', 'geoPoint': {'lat': 35.17959, 'lon': -80.64729}}, {'zip': '16507', 'city': 'Erie', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Erie Retina Research', 'geoPoint': {'lat': 42.12922, 'lon': -80.08506}}, {'zip': '02886', 'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Andover Eye Associates', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Keystone Research', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75243', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Axis Clinicals', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '24502', 'city': 'Lynchburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'Piedmont Eye Center', 'geoPoint': {'lat': 37.41375, 'lon': -79.14225}}, {'zip': '23230', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Eye Institute', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Scientific Advisor, Clinical R&D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aerie Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}