Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-01-04 @ 9:30 AM
Study NCT ID:
NCT02132169
Status:
COMPLETED
Last Update Posted:
2017-09-11
First Post:
2014-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Multi-Center Study Evaluating the Safety of AC-170 0.24%
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bergamini@nicox.com', 'phone': '817-529-9315', 'title': 'Michael V.W. Bergamini, PhD - Chief Scientific Officer/Executive Vice President', 'organization': 'Nicox Ophthalmics Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for the duration of the study. All subjects who received study medication were evaluable for the safety analysis.', 'description': 'Throughout the visits, staff collected all Adverse Events reported, elicited or observed.', 'eventGroups': [{'id': 'EG000', 'title': 'AC-170 0.24%', 'description': '1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24%', 'otherNumAtRisk': 341, 'otherNumAffected': 65, 'seriousNumAtRisk': 341, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'AC-170 0%', 'description': '1 drop in each eye 2 times daily for up to 6 weeks AC-170 0%', 'otherNumAtRisk': 171, 'otherNumAffected': 39, 'seriousNumAtRisk': 171, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Conjunctival Hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numEvents': 29, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 20, 'numAffected': 19}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ocular Hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vision Blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Instillation Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anaphylactic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 1 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AC-170 0.24%', 'description': '1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24%'}, {'id': 'OG001', 'title': 'AC-170 0%', 'description': '1 drop in each eye 2 times daily for up to 6 weeks AC-170 0%'}], 'classes': [{'title': 'Upon instillation', 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.36', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.02', 'groupId': 'OG001'}]}]}, {'title': '30 seconds post-instillation', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.82', 'groupId': 'OG001'}]}]}, {'title': '1 minute post-instillation', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation', 'description': 'Tolerability was assessed upon instillation of study medication, at 30 seconds and 1 minute post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT)'}, {'type': 'PRIMARY', 'title': 'Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 2 (Day 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AC-170 0.24%', 'description': '1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24%'}, {'id': 'OG001', 'title': 'AC-170 0%', 'description': '1 drop in each eye 2 times daily for up to 6 weeks AC-170 0%'}], 'classes': [{'title': 'Upon instillation', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': '30 seconds post-instillation', 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.74', 'groupId': 'OG001'}]}]}, {'title': '1 minute post-instillation', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation', 'description': 'Tolerability was assessed upon instillation of study medication, at 30 seconds and 1 minute post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT)'}, {'type': 'PRIMARY', 'title': 'Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 3 (Day 22)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AC-170 0.24%', 'description': '1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24%'}, {'id': 'OG001', 'title': 'AC-170 0%', 'description': '1 drop in each eye 2 times daily for up to 6 weeks AC-170 0%'}], 'classes': [{'title': 'Upon instillation', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.66', 'groupId': 'OG001'}]}]}, {'title': '30 seconds post-instillation', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.51', 'groupId': 'OG001'}]}]}, {'title': '1 minute post-instillation', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation', 'description': 'Tolerability was assessed upon instillation of study medication, at 30 seconds and 1 minute post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT)'}, {'type': 'SECONDARY', 'title': 'Safety of AC 170 0.024% Compared to Its Vehicle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AC-170 0.24%', 'description': '1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24%'}, {'id': 'OG001', 'title': 'AC-170 0%', 'description': '1 drop in each eye 2 times daily for up to 6 weeks AC-170 0%'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 Weeks', 'description': 'Safety measures (adverse events) of AC 170 0.024% compared to its vehicle were measured at Visit 1-4 and 5 (for subset of patients).', 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AC-170 0.24%', 'description': '1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24%'}, {'id': 'FG001', 'title': 'AC-170 0%', 'description': '1 drop in each eye 2 times daily for up to 6 weeks AC-170 0%'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '341'}, {'groupId': 'FG001', 'numSubjects': '171'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '326'}, {'groupId': 'FG001', 'numSubjects': '162'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'Subjects were recruited from four sites in the US.', 'preAssignmentDetails': 'There were 512 subjects enrolled, 24 subjects discontinued, and 488 subjects completed the study. Participant flow and baseline characteristics are presented for the 512 subjects that met all inclusion criteria and none of the exclusion criteria and were randomized to receive AC-170 0.24% or AC-170 0%.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'BG000'}, {'value': '171', 'groupId': 'BG001'}, {'value': '512', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AC-170 0.24%', 'description': '1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24%'}, {'id': 'BG001', 'title': 'AC-170 0%', 'description': '1 drop in each eye 2 times daily for up to 6 weeks AC-170 0%'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.9', 'spread': '19.36', 'groupId': 'BG000'}, {'value': '36.6', 'spread': '19.56', 'groupId': 'BG001'}, {'value': '35.4', 'spread': '19.42', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '2-6 years old', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}, {'title': '7-12 years old', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': '13-17 years old', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}, {'title': '>/= 18 years old', 'categories': [{'measurements': [{'value': '259', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '389', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '195', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '203', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '321', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '481', '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 (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '298', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '447', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '341', 'groupId': 'BG000'}, {'value': '171', 'groupId': 'BG001'}, {'value': '512', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 512}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'dispFirstSubmitDate': '2015-04-30', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-05', 'studyFirstSubmitDate': '2014-04-29', 'dispFirstSubmitQcDate': '2015-04-30', 'resultsFirstSubmitDate': '2017-06-27', 'studyFirstSubmitQcDate': '2014-05-05', 'dispFirstPostDateStruct': {'date': '2015-05-19', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-27', 'studyFirstPostDateStruct': {'date': '2014-05-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 1 (Day 1)', 'timeFrame': 'Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation', 'description': 'Tolerability was assessed upon instillation of study medication, at 30 seconds and 1 minute post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.'}, {'measure': 'Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 2 (Day 8)', 'timeFrame': 'Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation', 'description': 'Tolerability was assessed upon instillation of study medication, at 30 seconds and 1 minute post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.'}, {'measure': 'Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 3 (Day 22)', 'timeFrame': 'Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation', 'description': 'Tolerability was assessed upon instillation of study medication, at 30 seconds and 1 minute post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.'}], 'secondaryOutcomes': [{'measure': 'Safety of AC 170 0.024% Compared to Its Vehicle', 'timeFrame': 'Up to 12 Weeks', 'description': 'Safety measures (adverse events) of AC 170 0.024% compared to its vehicle were measured at Visit 1-4 and 5 (for subset of patients).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atopic Disease (Including Allergic Conjunctivitis)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety of AC-170 0.24% used twice daily in Healthy Adult Subjects and in Pediatric subjects with a history or family history of atopic disease (including allergic conjunctivitis).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 2 years of age\n* be able to self-administer eye drops or have a parent/legal guardian available for this purpose\n* if less than 18 years old have a history or family history of atopic disease (including allergic conjunctivitis)\n* have ocular health within normal limits\n\nExclusion Criteria:\n\n* known contraindications or sensitivities to the study medication or its components\n* any ocular condition that, in the opinion of the investigator, could affect the subjects safety trial parameters\n* use of disallowed medication during the period indicated prior to the enrollment or during the study'}, 'identificationModule': {'nctId': 'NCT02132169', 'briefTitle': 'A Multi-Center Study Evaluating the Safety of AC-170 0.24%', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aciex Therapeutics, Inc.'}, 'officialTitle': 'A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AC-170 0.24% Ophthalmic Solution Used Twice Daily in Healthy Adult Subjects and in Pediatric Subjects With a History or Family History of Atopic Disease (Including Allergic Conjunctivitis)', 'orgStudyIdInfo': {'id': '14-100-0006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AC-170 0.24%', 'interventionNames': ['Drug: Drug: AC-170 0.24%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'AC-170 0%', 'interventionNames': ['Drug: AC-170 0%']}], 'interventions': [{'name': 'Drug: AC-170 0.24%', 'type': 'DRUG', 'otherNames': ['1 drop in each eye 2 times daily for up to 6 weeks'], 'armGroupLabels': ['AC-170 0.24%']}, {'name': 'AC-170 0%', 'type': 'DRUG', 'otherNames': ['1 drop in each eye 2 times daily for up to 6 weeks'], 'armGroupLabels': ['AC-170 0%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01810', 'city': 'Andover', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Ora, Inc.', 'geoPoint': {'lat': 42.65843, 'lon': -71.137}}], 'overallOfficials': [{'name': 'Stacey L Ackerman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Philadelphia Eye Associates'}, {'name': 'Dawn K De Castro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Andover Eye Associates'}, {'name': 'Edward J Meier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Apex Eye'}, {'name': 'Eugene E Protzko, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seidenberg Protzko Eye Associates'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aciex Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}