Viewing Study NCT03320434

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Ignite Creation Date: 2025-12-25 @ 2:19 AM
Ignite Modification Date: 2026-02-20 @ 3:32 PM
Study NCT ID: NCT03320434
Status: COMPLETED
Last Update Posted: 2022-10-17
First Post: 2017-10-19
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Study Evaluating the Efficacy and Safety of PRT-2761 for the Treatment of Acute and Chronic Allergic Conjunctivitis
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003233', 'term': 'Conjunctivitis, Allergic'}], 'ancestors': [{'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069605', 'term': 'Olopatadine Hydrochloride'}, {'id': 'D008775', 'term': 'Methylprednisolone'}], 'ancestors': [{'id': 'D003990', 'term': 'Dibenzoxepins'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cpearson@oraclinical.com', 'phone': '978-685-8900', 'title': 'Caitlin Pearson', 'organization': 'Ora, Inc'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected through study completion, an average of 9 weeks. 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': 'PRT-2761 0.5%', 'description': 'PRT-2761 0.5%: Six drops in each eye over a 17 day period.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 4, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PRT-2761 1%', 'description': 'PRT-2761 1%: Six drops in each eye over a 17 day period.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 9, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Patanol', 'description': 'Patanol: Six drops in each eye over a 17 day period.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 1, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'PRT-2761 0%', 'description': 'PRT-2761 0%: Six drops in each eye over a 17 day period.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 7, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Visual Acuity Reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctival Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctival Pigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Corneal Opacity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye Discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eyelid Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Meibomian Gland Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Punctate Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Retinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin Discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritable Bowel Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Carpal Tunnel Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PRT-2761 0.5%', 'description': 'PRT-2761 0.5%: Six drops in each eye over a 17 day period.'}, {'id': 'OG001', 'title': 'PRT-2761 1%', 'description': 'PRT-2761 1%: Six drops in each eye over a 17 day period.'}, {'id': 'OG002', 'title': 'Patanol', 'description': 'Patanol: Six drops in each eye over a 17 day period.'}, {'id': 'OG003', 'title': 'PRT-2761 0%', 'description': 'PRT-2761 0%: Six drops in each eye over a 17 day period.'}], 'classes': [{'title': '5 minutes post-CAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.573', 'spread': '0.9246', 'groupId': 'OG000'}, {'value': '2.500', 'spread': '0.7792', 'groupId': 'OG001'}, {'value': '1.217', 'spread': '0.8826', 'groupId': 'OG002'}, {'value': '2.647', 'spread': '0.8170', 'groupId': 'OG003'}]}]}, {'title': '7 minutes post-CAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.677', 'spread': '0.8879', 'groupId': 'OG000'}, {'value': '2.509', 'spread': '0.8114', 'groupId': 'OG001'}, {'value': '1.358', 'spread': '0.8627', 'groupId': 'OG002'}, {'value': '2.629', 'spread': '0.7459', 'groupId': 'OG003'}]}]}, {'title': '10 minutes post-CAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.250', 'spread': '1.0878', 'groupId': 'OG000'}, {'value': '2.293', 'spread': '1.0135', 'groupId': 'OG001'}, {'value': '1.258', 'spread': '0.9727', 'groupId': 'OG002'}, {'value': '2.190', 'spread': '0.8754', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post CAC exposure at 5, 7, and 10 minutes post CAC on Day 1', 'description': 'Ocular Itching was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no itching) to 4=severe (worst/most itching). The ocular itching was averaged across all subjects at each time point.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized Participants Population - All participants who received study treatment.\n\nNote: Pred forte subjects receive Patanol up to and including Visit 5a and are analyzed as Patanol subjects for those visits.'}, {'type': 'PRIMARY', 'title': 'Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PRT-2761 0.5%', 'description': 'PRT-2761 0.5%: Six drops in each eye over a 17 day period.'}, {'id': 'OG001', 'title': 'PRT-2761 1%', 'description': 'PRT-2761 1%: Six drops in each eye over a 17 day period.'}, {'id': 'OG002', 'title': 'Patanol', 'description': 'Patanol: Six drops in each eye over a 17 day period.'}, {'id': 'OG003', 'title': 'PRT-2761 0%', 'description': 'PRT-2761 0%: Six drops in each eye over a 17 day period.'}], 'classes': [{'title': '5 minutes post-CAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.431', 'spread': '1.1415', 'groupId': 'OG000'}, {'value': '2.611', 'spread': '0.7731', 'groupId': 'OG001'}, {'value': '0.775', 'spread': '0.7172', 'groupId': 'OG002'}, {'value': '2.527', 'spread': '0.9288', 'groupId': 'OG003'}]}]}, {'title': '7 minutes post-CAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.362', 'spread': '1.0724', 'groupId': 'OG000'}, {'value': '2.602', 'spread': '0.7883', 'groupId': 'OG001'}, {'value': '0.808', 'spread': '0.7505', 'groupId': 'OG002'}, {'value': '2.366', 'spread': '0.9317', 'groupId': 'OG003'}]}]}, {'title': '10 minutes post-CAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.922', 'spread': '1.1242', 'groupId': 'OG000'}, {'value': '2.204', 'spread': '1.0630', 'groupId': 'OG001'}, {'value': '0.833', 'spread': '0.8077', 'groupId': 'OG002'}, {'value': '1.929', 'spread': '0.9425', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post CAC exposure at 5, 7, and 10 minutes post CAC on Day 15', 'description': 'Ocular Itching was assessed by the subjects using a 0 to 4 point scale(0=none (best/no itching) to 4=severe (worst/most itching)). The ocular itching was averaged across all subjects at each time point.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized Participants Population - All participants who received study treatment.\n\nNote: Pred forte subjects receive Patanol up to and including Visit 5a and are analyzed as Patanol subjects for those visits.'}, {'type': 'PRIMARY', 'title': 'Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PRT-2761 0.5%', 'description': 'PRT-2761 0.5%: Six drops in each eye over a 17 day period.'}, {'id': 'OG001', 'title': 'PRT-2761 1%', 'description': 'PRT-2761 1%: Six drops in each eye over a 17 day period.'}, {'id': 'OG002', 'title': 'Patanol', 'description': 'Patanol: Six drops in each eye over a 17 day period.'}, {'id': 'OG003', 'title': 'PRT-2761 0%', 'description': 'PRT-2761 0%: Six drops in each eye over a 17 day period.'}], 'classes': [{'title': '7 minutes post-CAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.282', 'spread': '0.6479', 'groupId': 'OG000'}, {'value': '1.491', 'spread': '0.5919', 'groupId': 'OG001'}, {'value': '1.592', 'spread': '0.7236', 'groupId': 'OG002'}, {'value': '1.957', 'spread': '0.4913', 'groupId': 'OG003'}]}]}, {'title': '15 minutes post-CAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.411', 'spread': '0.6142', 'groupId': 'OG000'}, {'value': '1.526', 'spread': '0.5989', 'groupId': 'OG001'}, {'value': '1.833', 'spread': '0.7350', 'groupId': 'OG002'}, {'value': '2.181', 'spread': '0.3774', 'groupId': 'OG003'}]}]}, {'title': '20 minutes post-CAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.371', 'spread': '0.5841', 'groupId': 'OG000'}, {'value': '1.603', 'spread': '0.6251', 'groupId': 'OG001'}, {'value': '1.917', 'spread': '0.6833', 'groupId': 'OG002'}, {'value': '2.164', 'spread': '0.4496', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 1.', 'description': 'Conjunctival Redness was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no redness) to 4=severe (worst/most redness)).\n\nThe conjunctival redness was averaged across all subjects at each time point.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized Participants Population - All participants who received study treatment.\n\nNote: Pred forte subjects receive Patanol up to and including Visit 5a and are analyzed as Patanol subjects for those visits.'}, {'type': 'PRIMARY', 'title': 'Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PRT-2761 0.5%', 'description': 'PRT-2761 0.5%: Six drops in each eye over a 17 day period.'}, {'id': 'OG001', 'title': 'PRT-2761 1%', 'description': 'PRT-2761 1%: Six drops in each eye over a 17 day period.'}, {'id': 'OG002', 'title': 'Patanol', 'description': 'Patanol: Six drops in each eye over a 17 day period.'}, {'id': 'OG003', 'title': 'PRT-2761 0%', 'description': 'PRT-2761 0%: Six drops in each eye over a 17 day period.'}], 'classes': [{'title': '7 minutes post-CAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.723', 'spread': '0.5787', 'groupId': 'OG000'}, {'value': '2.056', 'spread': '0.4458', 'groupId': 'OG001'}, {'value': '1.242', 'spread': '0.7296', 'groupId': 'OG002'}, {'value': '1.973', 'spread': '0.4731', 'groupId': 'OG003'}]}]}, {'title': '15 minutes post-CAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.920', 'spread': '0.6703', 'groupId': 'OG000'}, {'value': '2.176', 'spread': '0.4894', 'groupId': 'OG001'}, {'value': '1.617', 'spread': '0.7478', 'groupId': 'OG002'}, {'value': '1.991', 'spread': '0.5464', 'groupId': 'OG003'}]}]}, {'title': '20 minutes post-CAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.857', 'spread': '0.6289', 'groupId': 'OG000'}, {'value': '2.222', 'spread': '0.6699', 'groupId': 'OG001'}, {'value': '1.592', 'spread': '0.7266', 'groupId': 'OG002'}, {'value': '2.036', 'spread': '0.6372', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 15.', 'description': 'Conjunctival Redness was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no redness) to 4=severe (worst/most redness)).\n\nThe conjunctival redness was averaged across all subjects at each time point.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized Participants Population - All participants who received study treatment.\n\nNote: Pred forte subjects receive Patanol up to and including Visit 5a.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PRT-2761 0.5%', 'description': 'PRT-2761 0.5%: Six drops in each eye over a 17 day period.'}, {'id': 'FG001', 'title': 'PRT-2761 1%', 'description': 'PRT-2761 1%: Six drops in each eye over a 17 day period.'}, {'id': 'FG002', 'title': 'Patanol', 'description': 'Patanol: Six drops in each eye over a 17 day period.'}, {'id': 'FG003', 'title': 'PRT-2761 0%', 'description': 'PRT-2761 0%: Six drops in each eye over a 17 day period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '28'}, {'groupId': 'FG003', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'Subjects were recruited from one site in the US.', 'preAssignmentDetails': 'One hundred and twenty participants enrolled and 97 subjects completed the study. Participant flow and baseline characteristics are presented for 120 subjects that met all inclusion, none of the exclusion criteria, and were randomized to receive one of five treatments based on the randomization list.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '120', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'PRT-2761 0.5%', 'description': 'PRT-2761 0.5%: Six drops in each eye over a 17 day period.'}, {'id': 'BG001', 'title': 'PRT-2761 1%', 'description': 'PRT-2761 1%: Six drops in each eye over a 17 day period.'}, {'id': 'BG002', 'title': 'Patanol', 'description': 'Patanol: Six drops in each eye over a 17 day period.'}, {'id': 'BG003', 'title': 'PRT-2761 0%', 'description': 'PRT-2761 0%: Six drops in each eye over a 17 day period.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '114', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52', 'spread': '14.49', 'groupId': 'BG000'}, {'value': '49', 'spread': '12.98', 'groupId': 'BG001'}, {'value': '46', 'spread': '10.81', 'groupId': 'BG002'}, {'value': '52', 'spread': '9.21', 'groupId': 'BG003'}, {'value': '50', 'spread': '12.98', 'groupId': 'BG004'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}, {'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'}]}]}], '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': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '106', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '120', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Iris Color', 'classes': [{'categories': [{'title': 'Black', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Blue', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}, {'title': 'Brown', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '57', 'groupId': 'BG004'}]}, {'title': 'Hazel', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}, {'title': 'Green', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Average Post-CAC Itching Score at Baseline', 'classes': [{'categories': [{'title': '≤ 2.5', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}]}, {'title': '> 2.5', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '97', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Allergen Type', 'classes': [{'categories': [{'title': 'Seasonal', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '83', 'groupId': 'BG004'}]}, {'title': 'Perennial', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Confocal Participation', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '83', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-18', 'size': 6860642, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-05-05T15:36', 'hasProtocol': True}, {'date': '2017-11-27', 'size': 1651655, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-05-09T13:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'dispFirstSubmitDate': '2020-08-19', 'completionDateStruct': {'date': '2018-02-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-13', 'studyFirstSubmitDate': '2017-10-19', 'dispFirstSubmitQcDate': '2022-10-13', 'resultsFirstSubmitDate': '2022-07-11', 'studyFirstSubmitQcDate': '2017-10-23', 'dispFirstPostDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-13', 'studyFirstPostDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1', 'timeFrame': 'post CAC exposure at 5, 7, and 10 minutes post CAC on Day 1', 'description': 'Ocular Itching was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no itching) to 4=severe (worst/most itching). The ocular itching was averaged across all subjects at each time point.'}, {'measure': 'Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15', 'timeFrame': 'post CAC exposure at 5, 7, and 10 minutes post CAC on Day 15', 'description': 'Ocular Itching was assessed by the subjects using a 0 to 4 point scale(0=none (best/no itching) to 4=severe (worst/most itching)). The ocular itching was averaged across all subjects at each time point.'}, {'measure': 'Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1', 'timeFrame': 'post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 1.', 'description': 'Conjunctival Redness was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no redness) to 4=severe (worst/most redness)).\n\nThe conjunctival redness was averaged across all subjects at each time point.'}, {'measure': 'Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15', 'timeFrame': 'post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 15.', 'description': 'Conjunctival Redness was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no redness) to 4=severe (worst/most redness)).\n\nThe conjunctival redness was averaged across all subjects at each time point.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Allergic Conjunctivitis']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of two concentrations of PRT-2761 as a topical ophthalmic solution for the treatment of the signs and symptoms of acute and chronic allergic conjunctivitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* be at least 18 years old\n* be willing and able to avoid all disallowed medications and contact lenses\n* must have a pregnancy test if of childbearing potential\n* must be able to read an eye chart from 10 feet away\n\nExclusion Criteria:\n\n* must not have any allergies to the study medications\n* must not have any ocular or non ocular condition that investigator feels will interfere with study parameters\n* must not have used an investigational drug or device in the past 30 days or concurrently enrolled in another investigational trial'}, 'identificationModule': {'nctId': 'NCT03320434', 'briefTitle': 'Study Evaluating the Efficacy and Safety of PRT-2761 for the Treatment of Acute and Chronic Allergic Conjunctivitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'ORA, Inc.'}, 'officialTitle': 'A Single-Center, Randomized, Double-Masked, Vehicle and Active-Controlled, Dose-Ranging Phase 2 Study Evaluating the Efficacy and Safety of PRT-2761 for the Treatment of Acute and Chronic Allergic Conjunctivitis Using the Conjunctival Allergen Challenge Model (Ora-CAC®)', 'orgStudyIdInfo': {'id': '17-100-0008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRT-2761 0.5%', 'interventionNames': ['Drug: PRT-2761 0.5%']}, {'type': 'EXPERIMENTAL', 'label': 'PRT-2761 1%', 'interventionNames': ['Drug: PRT-2761 1%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patanol', 'interventionNames': ['Drug: Patanol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pred-forte', 'interventionNames': ['Drug: Pred-forte']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PRT-2761 0%', 'interventionNames': ['Drug: PRT-2761 0%']}], 'interventions': [{'name': 'PRT-2761 0.5%', 'type': 'DRUG', 'description': 'Six drops in each eye over a 17 day period.', 'armGroupLabels': ['PRT-2761 0.5%']}, {'name': 'PRT-2761 1%', 'type': 'DRUG', 'description': 'Six drops in each eye over a 17 day period.', 'armGroupLabels': ['PRT-2761 1%']}, {'name': 'Patanol', 'type': 'DRUG', 'description': 'Six drops in each eye over a 17 day period.', 'armGroupLabels': ['Patanol']}, {'name': 'Pred-forte', 'type': 'DRUG', 'description': 'Four drops in each eye over a 3 day period.', 'armGroupLabels': ['Pred-forte']}, {'name': 'PRT-2761 0%', 'type': 'DRUG', 'description': 'Six drops in each eye over a 17 day period.', 'armGroupLabels': ['PRT-2761 0%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01810', 'city': 'Andover', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Andover Eye Associates', 'geoPoint': {'lat': 42.65843, 'lon': -71.137}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ORA, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}