Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-02-25 @ 5:35 PM
Study NCT ID:
NCT04089735
Status:
COMPLETED
Last Update Posted:
2023-06-27
First Post:
2019-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 to Treat Inflammation and Pain After Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'admin@aimmaxrx.com', 'phone': '919-797-1146', 'title': 'Chief Medical Officer', 'organization': 'AimMax Therapeutics Inc.'}, 'certainAgreement': {'otherDetails': 'The Institutions and Investigators participating in this trial shall have no right to publish or present the results of this study without the prior written consent of the Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Exploratory Phase 2 study with small sample sizes'}}, 'adverseEventsModule': {'timeFrame': 'Serious adverse events were collected from informed consent through Post-operative Day 28 for Study Part A and informed consent through Post-operative Day 22 for Study Part B. Other (not Including Serious) adverse events were collected from the first dose through Post-operative Day 28 for Study Part A; from the first dose through Post-operative Day 22 for Study Part B.', 'eventGroups': [{'id': 'EG000', 'title': 'APP13007 0.05% Twice Daily (BID)', 'description': '1 drop 0.05% APP13007 twice daily for 21 days to the operated eye\n\nAPP13007, 0.05%: APP13007 eye drop, 0.05%', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 2, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'APP13007 0.05% Placebo Twice Daily (BID)', 'description': '1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye\n\nAPP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 6, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'APP13007 0.05% Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007, 0.05%: APP13007 eye drop, 0.05%', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 2, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 5, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'APP13007 0.1% Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007, 0.1%: APP13007 eye drop, 0.1%', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 1, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007 Placebo, 0.1%: APP13007 placebo eyedrop, 0.1%', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 2, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Eye inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Treatment Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'APP13007 0.05% Twice Daily (BID)', 'description': '1 drop 0.05% APP13007 twice daily for 21 days to the operated eye\n\nAPP13007, 0.05%: APP13007 eye drop, 0.05%'}, {'id': 'OG001', 'title': 'APP13007 0.05% Placebo Twice Daily (BID)', 'description': '1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye\n\nAPP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%'}, {'id': 'OG002', 'title': 'APP13007 0.05% Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007, 0.05%: APP13007 eye drop, 0.05%'}, {'id': 'OG003', 'title': 'APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%'}, {'id': 'OG004', 'title': 'APP13007 0.1% Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007, 0.1%: APP13007 eye drop, 0.1%'}, {'id': 'OG005', 'title': 'APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007 Placebo, 0.1%: APP13007 placebo eyedrop, 0.1%'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From First dose to Post-operative Day 28 (Part A) or Day 22 (Part B)', 'description': 'Number of treatment emergent adverse events and number of participants.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'PRIMARY', 'title': 'Intraocular Pressure - Change From Baseline (POD1 Prior to Dosing) to End-of-Treatment in the Operated Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'APP13007 0.05% Twice Daily (BID)', 'description': '1 drop 0.05% APP13007 twice daily for 21 days to the operated eye\n\nAPP13007, 0.05%: APP13007 eye drop, 0.05%'}, {'id': 'OG001', 'title': 'APP13007 0.05% Placebo Twice Daily (BID)', 'description': '1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye\n\nAPP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%'}, {'id': 'OG002', 'title': 'APP13007 0.05% Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007, 0.05%: APP13007 eye drop, 0.05%'}, {'id': 'OG003', 'title': 'APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%'}, {'id': 'OG004', 'title': 'APP13007 0.1% Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007, 0.1%: APP13007 eye drop, 0.1%'}, {'id': 'OG005', 'title': 'APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007 Placebo, 0.1%: APP13007 placebo eyedrop, 0.1%'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '4.0', 'groupId': 'OG001'}, {'value': '-2.37', 'spread': '3.71', 'groupId': 'OG002'}, {'value': '-2.38', 'spread': '3.14', 'groupId': 'OG003'}, {'value': '-1.28', 'spread': '4.36', 'groupId': 'OG004'}, {'value': '-1.00', 'spread': '2.30', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B)', 'description': 'Intraocular pressure is measured in mm Hg at each study visit with a Goldmann applanation tonometer. The change from baseline is calculated by subtracting the pretreatment measurement value from the value at each visit.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population - Participants who had the IOP data at End of Treatment'}, {'type': 'PRIMARY', 'title': 'Absolute Anterior Chamber Cell Count - Change From Baseline (POD1 Prior to Dosing) to POD 15 in the Operated Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'APP13007 0.05% Twice Daily (BID)', 'description': '1 drop 0.05% APP13007 twice daily for 21 days to the operated eye\n\nAPP13007, 0.05%: APP13007 eye drop, 0.05%'}, {'id': 'OG001', 'title': 'APP13007 0.05% Placebo Twice Daily (BID)', 'description': '1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye\n\nAPP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%'}, {'id': 'OG002', 'title': 'APP13007 0.05% Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007, 0.05%: APP13007 eye drop, 0.05%'}, {'id': 'OG003', 'title': 'APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%'}, {'id': 'OG004', 'title': 'APP13007 0.1% Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007, 0.1%: APP13007 eye drop, 0.1%'}, {'id': 'OG005', 'title': 'APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007 Placebo, 0.1%: APP13007 placebo eyedrop, 0.1%'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.64', 'spread': '5.80', 'groupId': 'OG000'}, {'value': '-9.24', 'spread': '10.34', 'groupId': 'OG001'}, {'value': '-11.48', 'spread': '8.65', 'groupId': 'OG002'}, {'value': '-5.67', 'spread': '11.73', 'groupId': 'OG003'}, {'value': '-11.90', 'spread': '4.73', 'groupId': 'OG004'}, {'value': '-7.43', 'spread': '11.15', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Post-operative Day 15', 'description': 'The number of cells in the anterior chamber of the eye are counted using slit-lamp biomicroscopy at each study visit and the results are reported as number of cells in a 1mm x 1mm area.', 'unitOfMeasure': 'cells/mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population. Last observation carried forward (LOCF) imputation method.'}, {'type': 'PRIMARY', 'title': 'Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'APP13007 0.05% Twice Daily (BID)', 'description': '1 drop 0.05% APP13007 twice daily for 21 days to the operated eye\n\nAPP13007, 0.05%: APP13007 eye drop, 0.05%'}, {'id': 'OG001', 'title': 'APP13007 0.05% Placebo Twice Daily (BID)', 'description': '1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye\n\nAPP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%'}, {'id': 'OG002', 'title': 'APP13007 0.05% Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007, 0.05%: APP13007 eye drop, 0.05%'}, {'id': 'OG003', 'title': 'APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%'}, {'id': 'OG004', 'title': 'APP13007 0.1% Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007, 0.1%: APP13007 eye drop, 0.1%'}, {'id': 'OG005', 'title': 'APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007 Placebo, 0.1%: APP13007 placebo eyedrop, 0.1%'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.179', 'spread': '0.266', 'groupId': 'OG000'}, {'value': '-0.073', 'spread': '0.174', 'groupId': 'OG001'}, {'value': '-0.106', 'spread': '0.184', 'groupId': 'OG002'}, {'value': '-0.024', 'spread': '0.133', 'groupId': 'OG003'}, {'value': '-0.130', 'spread': '0.165', 'groupId': 'OG004'}, {'value': '-0.025', 'spread': '0.192', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B)', 'description': "The visual acuity in each eye is corrected using the pinhole method and the acuity is quantified on a logMAR (minimal angle of resolution) scale using the 'Early Treatment Diabetic Retinopathy Study' \\[ETDRS\\] charts for right and left eyes. A logMAR Score is calculated using the number of incorrect letters.", 'unitOfMeasure': 'logMAR score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population. Last observation carried forward (LOCF) imputation method.'}, {'type': 'PRIMARY', 'title': 'Ocular Pain Grade - Change From Baseline (POD1 Prior to Dosing) to POD15 in the Operated Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'APP13007 0.05% Twice Daily (BID)', 'description': '1 drop 0.05% APP13007 twice daily for 21 days to the operated eye\n\nAPP13007, 0.05%: APP13007 eye drop, 0.05%'}, {'id': 'OG001', 'title': 'APP13007 0.05% Placebo Twice Daily (BID)', 'description': '1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye\n\nAPP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%'}, {'id': 'OG002', 'title': 'APP13007 0.05% Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007, 0.05%: APP13007 eye drop, 0.05%'}, {'id': 'OG003', 'title': 'APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%'}, {'id': 'OG004', 'title': 'APP13007 0.1% Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007, 0.1%: APP13007 eye drop, 0.1%'}, {'id': 'OG005', 'title': 'APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007 Placebo, 0.1%: APP13007 placebo eyedrop, 0.1%'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '1.0', 'groupId': 'OG002'}, {'value': '-0.4', 'spread': '2.0', 'groupId': 'OG003'}, {'value': '-0.6', 'spread': '1.2', 'groupId': 'OG004'}, {'value': '-0.3', 'spread': '1.5', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Post-operative Day 15', 'description': 'Ocular pain is measured in each eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 4 = severe pain).', 'unitOfMeasure': 'grade', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population. Last observation carried forward (LOCF) imputation method.'}, {'type': 'SECONDARY', 'title': 'Subjects With Anterior Chamber Cell Count = 0 at POD15 in the Operated Study Eye Without Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'APP13007 0.05% Twice Daily (BID)', 'description': '1 drop 0.05% APP13007 twice daily for 21 days to the operated eye\n\nAPP13007, 0.05%: APP13007 eye drop, 0.05%'}, {'id': 'OG001', 'title': 'APP13007 0.05% Placebo Twice Daily (BID)', 'description': '1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye\n\nAPP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%'}, {'id': 'OG002', 'title': 'APP13007 0.05% Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007, 0.05%: APP13007 eye drop, 0.05%'}, {'id': 'OG003', 'title': 'APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%'}, {'id': 'OG004', 'title': 'APP13007 0.1% Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007, 0.1%: APP13007 eye drop, 0.1%'}, {'id': 'OG005', 'title': 'APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007 Placebo, 0.1%: APP13007 placebo eyedrop, 0.1%'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-operative Day 15', 'description': 'The number of cells in the anterior chamber of the eye are counted using slit-lamp biomicroscopy at each study visit and the results are reported as number of cells in a 1mm x 1mm area.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population. Last observation carried forward (LOCF) imputation method.'}, {'type': 'SECONDARY', 'title': 'Subjects With Ocular Pain Grade = 0 at POD 15 in the Operated Study Eye Without Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'APP13007 0.05% Twice Daily (BID)', 'description': '1 drop 0.05% APP13007 twice daily for 21 days to the operated eye\n\nAPP13007, 0.05%: APP13007 eye drop, 0.05%'}, {'id': 'OG001', 'title': 'APP13007 0.05% Placebo Twice Daily (BID)', 'description': '1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye\n\nAPP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%'}, {'id': 'OG002', 'title': 'APP13007 0.05% Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007, 0.05%: APP13007 eye drop, 0.05%'}, {'id': 'OG003', 'title': 'APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%'}, {'id': 'OG004', 'title': 'APP13007 0.1% Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007, 0.1%: APP13007 eye drop, 0.1%'}, {'id': 'OG005', 'title': 'APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007 Placebo, 0.1%: APP13007 placebo eyedrop, 0.1%'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-operative Day 15', 'description': 'Ocular pain is measured in each eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 4 = severe pain).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population. Last observation carried forward (LOCF) imputation method.'}, {'type': 'SECONDARY', 'title': 'Anterior Chamber Flare - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'APP13007 0.05% Twice Daily (BID)', 'description': '1 drop 0.05% APP13007 twice daily for 21 days to the operated eye\n\nAPP13007, 0.05%: APP13007 eye drop, 0.05%'}, {'id': 'OG001', 'title': 'APP13007 0.05% Placebo Twice Daily (BID)', 'description': '1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye\n\nAPP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%'}, {'id': 'OG002', 'title': 'APP13007 0.05% Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007, 0.05%: APP13007 eye drop, 0.05%'}, {'id': 'OG003', 'title': 'APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%'}, {'id': 'OG004', 'title': 'APP13007 0.1% Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007, 0.1%: APP13007 eye drop, 0.1%'}, {'id': 'OG005', 'title': 'APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007 Placebo, 0.1%: APP13007 placebo eyedrop, 0.1%'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.05', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '-0.39', 'spread': '0.94', 'groupId': 'OG001'}, {'value': '-0.77', 'spread': '0.81', 'groupId': 'OG002'}, {'value': '-0.48', 'spread': '0.96', 'groupId': 'OG003'}, {'value': '-0.64', 'spread': '0.49', 'groupId': 'OG004'}, {'value': '-0.10', 'spread': '1.04', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B)', 'description': 'The degree of turbidity (flare) in the anterior chamber of the eye is measured using slit-lamp biomicroscopy and quantified on a five-point (0-4) anterior chamber flare grade scale (0 = none; 4 = Intense). The change from baseline is calculated by subtracting the pretreatment measurement value from the value at each visit.', 'unitOfMeasure': 'grade', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population. Last observation carried forward (LOCF) imputation method.'}, {'type': 'SECONDARY', 'title': "Subjects Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'APP13007 0.05% Twice Daily (BID)', 'description': '1 drop 0.05% APP13007 twice daily for 21 days to the operated eye\n\nAPP13007, 0.05%: APP13007 eye drop, 0.05%'}, {'id': 'OG001', 'title': 'APP13007 0.05% Placebo Twice Daily (BID)', 'description': '1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye\n\nAPP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%'}, {'id': 'OG002', 'title': 'APP13007 0.05% Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007, 0.05%: APP13007 eye drop, 0.05%'}, {'id': 'OG003', 'title': 'APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%'}, {'id': 'OG004', 'title': 'APP13007 0.1% Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007, 0.1%: APP13007 eye drop, 0.1%'}, {'id': 'OG005', 'title': 'APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007 Placebo, 0.1%: APP13007 placebo eyedrop, 0.1%'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'First dose to Post-operative Day 22 (Part A) or Day 15 (Part B)', 'description': "Subjects who do not respond to study treatment after randomization (anterior chamber cell count \\> 30 cells or an increase in anterior chamber cell count by \\> 15 cells from pre-dose baseline or ≥ 2 grade of increase in anterior chamber flare from pre-dose baseline) are started on anti-inflammatory medication (referred to as 'Rescue' medication). The number of subjects starting 'Rescue' medication is recorded at each study visit.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'APP13007 0.05% Twice Daily (BID)', 'description': '1 drop 0.05% APP13007 twice daily for 21 days to the operated eye\n\nAPP13007, 0.05%: APP13007 eye drop, 0.05%'}, {'id': 'FG001', 'title': 'APP13007 0.05% Placebo Twice Daily (BID)', 'description': '1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye\n\nAPP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%'}, {'id': 'FG002', 'title': 'APP13007 0.05% Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007, 0.05%: APP13007 eye drop, 0.05%'}, {'id': 'FG003', 'title': 'APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%'}, {'id': 'FG004', 'title': 'APP13007 0.1% Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007, 0.1%: APP13007 eye drop, 0.1%'}, {'id': 'FG005', 'title': 'APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007 Placebo, 0.1%: APP13007 placebo eyedrop, 0.1%'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '22'}, {'groupId': 'FG005', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '16'}, {'groupId': 'FG004', 'numSubjects': '21'}, {'groupId': 'FG005', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Rescue therapy, prohibited medication, withdrawn requiring alternate medication for inflammation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'A multi-center US study in which 9 sites recruited subjects between August 2019 and October 2019 for Study Part A and between November 2019 and February 2020 for Study Part B', 'preAssignmentDetails': 'Of 52 enrolled participants for Part A, 45 met inclusion criteria and were randomized to treatment. Of 113 enrolled participants for Part B, 87 met inclusion criteria and were randomized to treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}, {'value': '132', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'APP13007 0.05% Twice Daily (BID)', 'description': '1 drop 0.05% APP13007 twice daily for 21 days to the operated eye\n\nAPP13007, 0.05%: APP13007 eye drop, 0.05%'}, {'id': 'BG001', 'title': 'APP13007 0.05% Placebo Twice Daily (BID)', 'description': '1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye\n\nAPP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%'}, {'id': 'BG002', 'title': 'APP13007 0.05% Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007, 0.05%: APP13007 eye drop, 0.05%'}, {'id': 'BG003', 'title': 'APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%'}, {'id': 'BG004', 'title': 'APP13007 0.1% Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007, 0.1%: APP13007 eye drop, 0.1%'}, {'id': 'BG005', 'title': 'APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD)', 'description': '1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye\n\nAPP13007 Placebo, 0.1%: APP13007 placebo eyedrop, 0.1%'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.1', 'spread': '8.6', 'groupId': 'BG000'}, {'value': '66.3', 'spread': '6.6', 'groupId': 'BG001'}, {'value': '66.8', 'spread': '6.6', 'groupId': 'BG002'}, {'value': '70.0', 'spread': '5.0', 'groupId': 'BG003'}, {'value': '70.0', 'spread': '6.0', 'groupId': 'BG004'}, {'value': '65.2', 'spread': '6.3', 'groupId': 'BG005'}, {'value': '67.9', 'spread': '6.7', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '87', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '45', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '18', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '114', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '20', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '101', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}, {'value': '132', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-Treat Population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-11-15', 'size': 29469247, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-05-03T12:41', 'hasProtocol': True}, {'date': '2020-05-04', 'size': 1286746, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-05-03T12:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 165}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'dispFirstSubmitDate': '2021-04-01', 'completionDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-01', 'studyFirstSubmitDate': '2019-08-28', 'resultsFirstSubmitDate': '2023-05-04', 'studyFirstSubmitQcDate': '2019-09-12', 'dispFirstPostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-01', 'studyFirstPostDateStruct': {'date': '2019-09-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Treatment Emergent Adverse Events', 'timeFrame': 'From First dose to Post-operative Day 28 (Part A) or Day 22 (Part B)', 'description': 'Number of treatment emergent adverse events and number of participants.'}, {'measure': 'Intraocular Pressure - Change From Baseline (POD1 Prior to Dosing) to End-of-Treatment in the Operated Study Eye', 'timeFrame': 'Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B)', 'description': 'Intraocular pressure is measured in mm Hg at each study visit with a Goldmann applanation tonometer. The change from baseline is calculated by subtracting the pretreatment measurement value from the value at each visit.'}, {'measure': 'Absolute Anterior Chamber Cell Count - Change From Baseline (POD1 Prior to Dosing) to POD 15 in the Operated Study Eye', 'timeFrame': 'Baseline and Post-operative Day 15', 'description': 'The number of cells in the anterior chamber of the eye are counted using slit-lamp biomicroscopy at each study visit and the results are reported as number of cells in a 1mm x 1mm area.'}, {'measure': 'Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye', 'timeFrame': 'Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B)', 'description': "The visual acuity in each eye is corrected using the pinhole method and the acuity is quantified on a logMAR (minimal angle of resolution) scale using the 'Early Treatment Diabetic Retinopathy Study' \\[ETDRS\\] charts for right and left eyes. A logMAR Score is calculated using the number of incorrect letters."}, {'measure': 'Ocular Pain Grade - Change From Baseline (POD1 Prior to Dosing) to POD15 in the Operated Study Eye', 'timeFrame': 'Baseline and Post-operative Day 15', 'description': 'Ocular pain is measured in each eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 4 = severe pain).'}], 'secondaryOutcomes': [{'measure': 'Subjects With Anterior Chamber Cell Count = 0 at POD15 in the Operated Study Eye Without Rescue Medication', 'timeFrame': 'Post-operative Day 15', 'description': 'The number of cells in the anterior chamber of the eye are counted using slit-lamp biomicroscopy at each study visit and the results are reported as number of cells in a 1mm x 1mm area.'}, {'measure': 'Subjects With Ocular Pain Grade = 0 at POD 15 in the Operated Study Eye Without Rescue Medication', 'timeFrame': 'Post-operative Day 15', 'description': 'Ocular pain is measured in each eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 4 = severe pain).'}, {'measure': 'Anterior Chamber Flare - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye', 'timeFrame': 'Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B)', 'description': 'The degree of turbidity (flare) in the anterior chamber of the eye is measured using slit-lamp biomicroscopy and quantified on a five-point (0-4) anterior chamber flare grade scale (0 = none; 4 = Intense). The change from baseline is calculated by subtracting the pretreatment measurement value from the value at each visit.'}, {'measure': "Subjects Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment", 'timeFrame': 'First dose to Post-operative Day 22 (Part A) or Day 15 (Part B)', 'description': "Subjects who do not respond to study treatment after randomization (anterior chamber cell count \\> 30 cells or an increase in anterior chamber cell count by \\> 15 cells from pre-dose baseline or ≥ 2 grade of increase in anterior chamber flare from pre-dose baseline) are started on anti-inflammatory medication (referred to as 'Rescue' medication). The number of subjects starting 'Rescue' medication is recorded at each study visit."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ocular Inflammation and Pain After Cataract Surgery']}, 'descriptionModule': {'briefSummary': 'This is a Phase 2a, 2-part study (designated Parts A and B) that will evaluate APP13007 dose strength and dosing frequency in a randomized double-masked fashion for comparison to the respective matching vehicle placebo. Part A will be conducted first to evaluate 0.05% APP13007 and matching vehicle placebo in an approximate 1:1 ratio in approximately 42 subjects who experience postoperative inflammation on the first day following routine, uncomplicated, cataract surgery and who meet all eligibility criteria. Based on the results of Part A, Part B of the study may be open for enrollment to evaluate 0.05% and/or 0.1% APP13007 at various dosing frequency in approximately 84 subjects, also in an approximate 1:1 ratio, active vs. placebo. In each Part, subjects will return periodically for study assessments during the treatment period and then for a follow-up visit approximately 1 week after stopping the study drug.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Expected to undergo unilateral uncomplicated cataract extraction via phacoemulsification and posterior chamber intraocular lens implantation in one eye.\n* In Investigator's opinion, have Early Treatment Diabetic Retinopathy Study estimated potential of 0.7 (20/100) or better in study eye.\n* Have \\> 10 and ≤ 30 cells in anterior chamber.\n* Have an intraocular pressure ≤ 30 mmHg.\n\nExclusion Criteria:\n\n* Have an anterior chamber cell count \\> 0 or any evidence of intraocular inflammation.\n* Have a score \\> 0 on Ocular Pain Assessment in either eye."}, 'identificationModule': {'nctId': 'NCT04089735', 'briefTitle': 'A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 to Treat Inflammation and Pain After Cataract Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Formosa Pharmaceuticals, Inc.'}, 'officialTitle': 'A Multicenter, Randomized, Double-Masked, Two-Part, Placebo-Controlled Phase 2A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 for the Treatment of Inflammation and Pain After Cataract Surgery', 'orgStudyIdInfo': {'id': 'CPN-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'APP13007 0.05% twice daily (BID) [Part A]', 'description': '1 drop 0.05% APP13007 twice daily for 21 days to the operated eye', 'interventionNames': ['Drug: APP13007, 0.05%']}, {'type': 'EXPERIMENTAL', 'label': 'APP13007 0.05% Placebo twice daily (BID) [Part A]', 'description': '1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye', 'interventionNames': ['Drug: APP13007 Placebo, 0.05%']}, {'type': 'EXPERIMENTAL', 'label': 'APP13007 0.05% twice daily (BID) and once daily (QD) [Part B]', 'description': '1 drop 0.05% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye', 'interventionNames': ['Drug: APP13007, 0.05%']}, {'type': 'EXPERIMENTAL', 'label': 'APP13007 0.05% Placebo twice daily (BID) and once daily (QD) [Part B]', 'description': '1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye', 'interventionNames': ['Drug: APP13007 Placebo, 0.05%']}, {'type': 'EXPERIMENTAL', 'label': 'APP13007 0.1% twice daily (BID) and once daily (QD) [Part B]', 'description': '1 drop 0.1% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye', 'interventionNames': ['Drug: APP13007, 0.1%']}, {'type': 'EXPERIMENTAL', 'label': 'APP13007 0.1% Placebo twice daily (BID) and once daily (QD) [Part B]', 'description': '1 drop matching vehicle placebo for 0.1% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye', 'interventionNames': ['Drug: APP13007 Placebo, 0.1%']}], 'interventions': [{'name': 'APP13007, 0.05%', 'type': 'DRUG', 'description': 'APP13007 eye drop, 0.05%', 'armGroupLabels': ['APP13007 0.05% twice daily (BID) [Part A]', 'APP13007 0.05% twice daily (BID) and once daily (QD) [Part B]']}, {'name': 'APP13007, 0.1%', 'type': 'DRUG', 'description': 'APP13007 eye drop, 0.1%', 'armGroupLabels': ['APP13007 0.1% twice daily (BID) and once daily (QD) [Part B]']}, {'name': 'APP13007 Placebo, 0.05%', 'type': 'DRUG', 'description': 'APP13007 placebo eyedrop, 0.05%', 'armGroupLabels': ['APP13007 0.05% Placebo twice daily (BID) [Part A]', 'APP13007 0.05% Placebo twice daily (BID) and once daily (QD) [Part B]']}, {'name': 'APP13007 Placebo, 0.1%', 'type': 'DRUG', 'description': 'APP13007 placebo eyedrop, 0.1%', 'armGroupLabels': ['APP13007 0.1% Placebo twice daily (BID) and once daily (QD) [Part B]']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Cornea and Cataract Consultants of Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90301', 'city': 'Inglewood', 'state': 'California', 'country': 'United States', 'facility': 'United Medical Research Institute', 'geoPoint': {'lat': 33.96168, 'lon': -118.35313}}, {'zip': '95670', 'city': 'Rancho Cordova', 'state': 'California', 'country': 'United States', 'facility': 'Martel Eye Medical Group', 'geoPoint': {'lat': 38.58907, 'lon': -121.30273}}, {'zip': '32204', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Levenson Eye Associates', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Bowden Eye and Associates', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '63131', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Ophthalmology Associates', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '18704', 'city': 'Kingston', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Eye Care Specialists', 'geoPoint': {'lat': 41.26175, 'lon': -75.89686}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Keystone Research Ltd.', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '79902', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'Cataract & Glaucoma Center', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}], 'overallOfficials': [{'name': 'Chief Medical Officer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AimMax Therapeutics Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Formosa Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}