Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-01 @ 4:42 PM
Study NCT ID:
NCT06582732
Status:
COMPLETED
Last Update Posted:
2024-10-15
First Post:
2024-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Performance of the Travoprost Intraocular Implant
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ldoan@glaukos.com', 'phone': '714-478-2287', 'title': 'Study Director', 'organization': 'Glaukos Corporation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Study was open-label, non-randomized and conducted at a single site; however, the endpoints were objective and analyses of aqueous humor concentrations of travoprost free acid and of residual travoprost in explants were performed by a third party'}}, 'adverseEventsModule': {'timeFrame': 'initial travoprost intracameral implant period plus 4 weeks post-exchange', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1 (12-month Exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 12\n\nTravoprost Intracameral Implant exchanged at Month 12: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 4, 'seriousNumAtRisk': 30, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Cohort 2 (3-month Exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 3\n\nTravoprost Intracameral Implant exchanged at Month 3: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 3', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort 3 (6-month Exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 6\n\nTravoprost Intracameral Implant exchanged at Month 6: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 6', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 5, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort 4 (24-month Exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 24\n\nTravoprost Intracameral Implant exchanged at Month 24: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 24', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 3, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Cohort 5 (21-month Exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 21\n\nTravoprost Intracameral Implant exchanged at Month 21: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 21', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Cohort 6 (18-month Exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 18\n\nTravoprost Intracameral Implant exchanged at Month 18: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 18', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 1, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Cohort 7 (15-month Exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 15\n\nTravoprost Intracameral Implant exchanged at Month 15: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 15', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 1, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Corona virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Iridodialysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hyphaema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Intraocular pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'seriousEvents': [{'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 12 Months Post-administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (12-month Exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 12\n\nTravoprost Intracameral Implant exchanged at Month 12: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12'}], 'classes': [{'categories': [{'measurements': [{'value': '5.57', 'spread': '3.02', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'month 12', 'description': 'concentration of travoprost free acid (ng/mL) in the aqueous humor 12 months post-administration as assessed by liquid chromatography tandem mass spectrometry (LC-MS/MS)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'study eyes'}, {'type': 'PRIMARY', 'title': 'Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 3 Months Post-administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2 (3-month Exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 3\n\nTravoprost Intracameral Implant exchanged at Month 3: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 3'}], 'classes': [{'categories': [{'measurements': [{'value': '4.98', 'spread': '2.50', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'month 3', 'description': 'concentration of travoprost free acid (ng/mL) in the aqueous humor 3 months post-administration as assessed by LC-MS/MS', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'study eyes'}, {'type': 'PRIMARY', 'title': 'Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 6 Months Post-administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3 (6-month Exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 6\n\nTravoprost Intracameral Implant exchanged at Month 6: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 6'}], 'classes': [{'categories': [{'measurements': [{'value': '3.74', 'spread': '2.22', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'month 6', 'description': 'concentration of travoprost free acid (ng/mL) in the aqueous humor 6 months post-administration as assessed by LC-MS/MS', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'study eyes'}, {'type': 'PRIMARY', 'title': 'Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 24 Months Post-administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4 (24-month Exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 24\n\nTravoprost Intracameral Implant exchanged at Month 24: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 24'}], 'classes': [{'categories': [{'measurements': [{'value': '3.35', 'spread': '1.51', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'month 24', 'description': 'concentration of travoprost free acid (ng/mL) in the aqueous humor 24 months post-administration as assessed by LC-MS/MS', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'study eyes'}, {'type': 'PRIMARY', 'title': 'Travoprost Free Acid Concentration(ng/mL) in Aqueous Humor 21 Months Post-administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 5 (21-month Exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 21\n\nTravoprost Intracameral Implant exchanged at Month 21: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 21'}], 'classes': [{'categories': [{'measurements': [{'value': '3.80', 'spread': '1.58', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'month 21', 'description': 'concentration of travoprost free acid (ng/mL) in the aqueous humor 21 months post-administration as assessed by LC-MS/MS', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'study eyes'}, {'type': 'PRIMARY', 'title': 'Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 18 Months Post-administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 6 (18-month Exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 18\n\nTravoprost Intracameral Implant exchanged at Month 18: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 18'}], 'classes': [{'categories': [{'measurements': [{'value': '2.22', 'spread': '1.24', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'month 18', 'description': 'concentration of travoprost free acid (ng/mL) in the aqueous humor 18 months post-administration as assessed by LC-MS/MS', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'study eyes'}, {'type': 'PRIMARY', 'title': 'Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 15 Months Post-administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 7 15-month Exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 15\n\nTravoprost Intracameral Implant exchanged at Month 15: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 15'}], 'classes': [{'categories': [{'measurements': [{'value': '2.03', 'spread': '0.736', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'month 15', 'description': 'concentration of travoprost free acid (ng/mL) in the aqueous humor 15 months post-administration as assessed by LC-MS/MS', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'study eyes'}, {'type': 'SECONDARY', 'title': 'Percent Residual Travoprost in Explanted Implant 12 Months Post-administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (12-month Exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 12\n\nTravoprost Intracameral Implant exchanged at Month 12: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12'}], 'classes': [{'categories': [{'measurements': [{'value': '50.2', 'spread': '6.58', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'month 12', 'description': 'percent of travoprost compared to baseline in explanted implant 12 months post-administration as assessed by high performance liquid chromatography (HPLC)', 'unitOfMeasure': 'percentage of initial', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'explanted travoprost intracameral implants'}, {'type': 'SECONDARY', 'title': 'Percent Residual Travoprost in Explanted Implant 3 Months Post-administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}, {'units': 'explanted implants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2 (3-month Exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 3\n\nTravoprost Intracameral Implant exchanged at Month 3: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 3'}], 'classes': [{'categories': [{'measurements': [{'value': '78.8', 'spread': '3.15', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'month 3', 'description': 'percent of travoprost compared to baseline in explanted implant 3 months post-administration as assessed by HPLC', 'unitOfMeasure': 'percentage of initial', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'explanted implants', 'denomUnitsSelected': 'explanted implants', 'populationDescription': 'explanted travoprost intracameral implants'}, {'type': 'SECONDARY', 'title': 'Percent Residual Travoprost in Explanted Implant 6 Months Post-administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}, {'units': 'explanted implants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3 (6-month Exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 6\n\nTravoprost Intracameral Implant exchanged at Month 6: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 6'}], 'classes': [{'categories': [{'measurements': [{'value': '69.8', 'spread': '8.51', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'month 6', 'description': 'percent of travoprost compared to baseline in explanted implant 6 months post-administration as assessed by HPLC', 'unitOfMeasure': 'percentage of initial', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'explanted implants', 'denomUnitsSelected': 'explanted implants', 'populationDescription': 'explanted travoprost intracameral implants'}, {'type': 'SECONDARY', 'title': 'Percent Residual Travoprost in Explanted Implant 24 Months Post-administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}, {'units': 'explanted implants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4 (24-month Exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 24\n\nTravoprost Intracameral Implant exchanged at Month 24: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 24'}], 'classes': [{'categories': [{'measurements': [{'value': '16.3', 'spread': '7.88', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'month 24', 'description': 'percent of travoprost compared to baseline in explanted implant 24 months post-administration as assessed by HPLC', 'unitOfMeasure': 'percentage of initial', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'explanted implants', 'denomUnitsSelected': 'explanted implants', 'populationDescription': 'explanted travoprost intracameral implants'}, {'type': 'SECONDARY', 'title': 'Percent Residual Travoprost in Explanted Implant 21 Months Post-administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'explanted implants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 5 (21-month Exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 21\n\nTravoprost Intracameral Implant exchanged at Month 21: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 21'}], 'classes': [{'categories': [{'measurements': [{'value': '28.0', 'spread': '5.76', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'month 21', 'description': 'percent of travoprost compared to baseline in explanted implant 21 months post-administration as assessed by HPLC', 'unitOfMeasure': 'percentage of initial', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'explanted implants', 'denomUnitsSelected': 'explanted implants', 'populationDescription': 'explanted travoprost intracameral implants'}, {'type': 'SECONDARY', 'title': 'Percent Residual Travoprost in Explanted Implant 18 Months Post-administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}, {'units': 'explanted implants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 6 (18-month Exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 18\n\nTravoprost Intracameral Implant exchanged at Month 18: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 18'}], 'classes': [{'categories': [{'measurements': [{'value': '34.8', 'spread': '7.09', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'month 18', 'description': 'percent of travoprost compared to baseline in explanted implant 18 months post-administration as assessed by HPLC', 'unitOfMeasure': 'percentage of initial', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'explanted implants', 'denomUnitsSelected': 'explanted implants', 'populationDescription': 'explanted travoprost intracameral implants'}, {'type': 'SECONDARY', 'title': 'Percent Residual Travoprost in Explanted Implant 15 Months Post-administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}, {'units': 'explanted implants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 7 (15-month Exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 15\n\nTravoprost Intracameral Implant exchanged at Month 15: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 15'}], 'classes': [{'categories': [{'measurements': [{'value': '38.6', 'spread': '8.23', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'month 15', 'description': 'percent of travoprost compared to baseline in explanted implant 15 months post-administration as assessed by HPLC', 'unitOfMeasure': 'percentage of initial', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'explanted implants', 'denomUnitsSelected': 'explanted implants', 'populationDescription': 'explanted travoprost intracameral implants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1 (12-month Exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 12\n\nTravoprost Intracameral Implant exchanged at Month 12: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12'}, {'id': 'FG001', 'title': 'Cohort 2 (3-month Exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 3\n\nTravoprost Intracameral Implant exchanged at Month 3: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 3'}, {'id': 'FG002', 'title': 'Cohort 3 (6-month Exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 6\n\nTravoprost Intracameral Implant exchanged at Month 6: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 6'}, {'id': 'FG003', 'title': 'Cohort 4 (24-month Exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 24\n\nTravoprost Intracameral Implant exchanged at Month 24: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 24'}, {'id': 'FG004', 'title': 'Cohort 5 (21-month Exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 21\n\nTravoprost intracameral implant exchanged at Month 21: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 21'}, {'id': 'FG005', 'title': 'Cohort 6 (18-month Exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 18\n\nTravoprost intracameral implant exchanged at Month 18: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 18'}, {'id': 'FG006', 'title': 'Cohort 7 (15-month Exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 15\n\nTravoprost intracameral implant exchanged at Month 15: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 15'}], 'periods': [{'title': 'Initial Study Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '30', 'numSubjects': '30'}, {'groupId': 'FG001', 'numUnits': '30', 'numSubjects': '30'}, {'groupId': 'FG002', 'numUnits': '30', 'numSubjects': '30'}, {'groupId': 'FG003', 'numUnits': '30', 'numSubjects': '30'}, {'groupId': 'FG004', 'numUnits': '30', 'numSubjects': '30'}, {'groupId': 'FG005', 'numUnits': '30', 'numSubjects': '30'}, {'groupId': 'FG006', 'numUnits': '30', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '29', 'numSubjects': '29'}, {'groupId': 'FG001', 'numUnits': '29', 'numSubjects': '29'}, {'groupId': 'FG002', 'numUnits': '28', 'numSubjects': '28'}, {'groupId': 'FG003', 'numUnits': '27', 'numSubjects': '27'}, {'groupId': 'FG004', 'numUnits': '25', 'numSubjects': '25'}, {'groupId': 'FG005', 'numUnits': '29', 'numSubjects': '29'}, {'groupId': 'FG006', 'numUnits': '28', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '1', 'numSubjects': '1'}, {'groupId': 'FG001', 'numUnits': '1', 'numSubjects': '1'}, {'groupId': 'FG002', 'numUnits': '2', 'numSubjects': '2'}, {'groupId': 'FG003', 'numUnits': '3', 'numSubjects': '3'}, {'groupId': 'FG004', 'numUnits': '5', 'numSubjects': '5'}, {'groupId': 'FG005', 'numUnits': '1', 'numSubjects': '1'}, {'groupId': 'FG006', 'numUnits': '2', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '2'}]}, {'type': 'Moved Away', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': 'Post-exchange Study Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '29', 'numSubjects': '29'}, {'groupId': 'FG001', 'numUnits': '29', 'numSubjects': '29'}, {'groupId': 'FG002', 'numUnits': '28', 'numSubjects': '28'}, {'groupId': 'FG003', 'numUnits': '27', 'numSubjects': '27'}, {'groupId': 'FG004', 'numUnits': '25', 'numSubjects': '25'}, {'groupId': 'FG005', 'numUnits': '29', 'numSubjects': '29'}, {'groupId': 'FG006', 'numUnits': '28', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '29', 'numSubjects': '29'}, {'groupId': 'FG001', 'numUnits': '29', 'numSubjects': '29'}, {'groupId': 'FG002', 'numUnits': '28', 'numSubjects': '28'}, {'groupId': 'FG003', 'numUnits': '27', 'numSubjects': '27'}, {'groupId': 'FG004', 'numUnits': '25', 'numSubjects': '25'}, {'groupId': 'FG005', 'numUnits': '29', 'numSubjects': '29'}, {'groupId': 'FG006', 'numUnits': '28', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG005', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG006', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'eyes'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}, {'value': '30', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}, {'value': '210', 'groupId': 'BG007'}]}, {'units': 'study eyes', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}, {'value': '30', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}, {'value': '210', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1 (12-month Exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 12\n\nTravoprost Intracameral Implant exchanged at Month 12: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12'}, {'id': 'BG001', 'title': 'Cohort 2 (3-month Exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 3\n\nTravoprost Intracameral Implant exchanged at Month 3: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 3'}, {'id': 'BG002', 'title': 'Cohort 3 (6-month Exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 6\n\nTravoprost Intracameral Implant exchanged at Month 6: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 6'}, {'id': 'BG003', 'title': 'Cohort 4 (24-month Exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 24\n\nTravoprost Intracameral Implant exchanged at Month 24: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 24'}, {'id': 'BG004', 'title': 'Cohort 5 (21-month Exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 21\n\nTravoprost intracameral implant exchanged at Month 21: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 21'}, {'id': 'BG005', 'title': 'Cohort 6 (18-month Exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 18\n\nTravoprost intracameral implant exchanged at Month 18: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 18'}, {'id': 'BG006', 'title': 'Cohort 7 (15-month Exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 15\n\nTravoprost intracameral implant exchanged at Month 15: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 15'}, {'id': 'BG007', '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'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}, {'value': '103', 'groupId': 'BG007'}]}, {'title': '>=65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '18', 'groupId': 'BG006'}, {'value': '107', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}, {'value': '103', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}, {'value': '14', 'groupId': 'BG006'}, {'value': '107', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': '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'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Asian', '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'}, {'value': '0', 'groupId': 'BG007'}]}, {'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'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Black or African American', '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'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'White', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}, {'value': '30', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}, {'value': '210', 'groupId': 'BG007'}]}, {'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'}, {'value': '0', 'groupId': 'BG007'}]}, {'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'}, {'value': '0', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Armenia', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}, {'value': '30', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}, {'value': '210', 'groupId': 'BG007'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Type of Disease', 'classes': [{'categories': [{'title': 'Open-angle glaucoma', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}, {'value': '30', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}, {'value': '210', 'groupId': 'BG007'}]}, {'title': 'Ocular hypertension', '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'}, {'value': '0', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'clinical diagnosis of disease type (open angle glaucoma or ocular hypertension)', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'study eyes', 'populationDescription': 'only a single eye (defined as the study eye) was analyzed in the study'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-09-18', 'size': 3761223, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-09-12T14:04', 'hasProtocol': True}, {'date': '2022-03-23', 'size': 6678178, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-09-12T14:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-19', 'studyFirstSubmitDate': '2024-08-30', 'resultsFirstSubmitDate': '2024-09-19', 'studyFirstSubmitQcDate': '2024-08-30', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-19', 'studyFirstPostDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 12 Months Post-administration', 'timeFrame': 'month 12', 'description': 'concentration of travoprost free acid (ng/mL) in the aqueous humor 12 months post-administration as assessed by liquid chromatography tandem mass spectrometry (LC-MS/MS)'}, {'measure': 'Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 3 Months Post-administration', 'timeFrame': 'month 3', 'description': 'concentration of travoprost free acid (ng/mL) in the aqueous humor 3 months post-administration as assessed by LC-MS/MS'}, {'measure': 'Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 6 Months Post-administration', 'timeFrame': 'month 6', 'description': 'concentration of travoprost free acid (ng/mL) in the aqueous humor 6 months post-administration as assessed by LC-MS/MS'}, {'measure': 'Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 24 Months Post-administration', 'timeFrame': 'month 24', 'description': 'concentration of travoprost free acid (ng/mL) in the aqueous humor 24 months post-administration as assessed by LC-MS/MS'}, {'measure': 'Travoprost Free Acid Concentration(ng/mL) in Aqueous Humor 21 Months Post-administration', 'timeFrame': 'month 21', 'description': 'concentration of travoprost free acid (ng/mL) in the aqueous humor 21 months post-administration as assessed by LC-MS/MS'}, {'measure': 'Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 18 Months Post-administration', 'timeFrame': 'month 18', 'description': 'concentration of travoprost free acid (ng/mL) in the aqueous humor 18 months post-administration as assessed by LC-MS/MS'}, {'measure': 'Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 15 Months Post-administration', 'timeFrame': 'month 15', 'description': 'concentration of travoprost free acid (ng/mL) in the aqueous humor 15 months post-administration as assessed by LC-MS/MS'}], 'secondaryOutcomes': [{'measure': 'Percent Residual Travoprost in Explanted Implant 12 Months Post-administration', 'timeFrame': 'month 12', 'description': 'percent of travoprost compared to baseline in explanted implant 12 months post-administration as assessed by high performance liquid chromatography (HPLC)'}, {'measure': 'Percent Residual Travoprost in Explanted Implant 3 Months Post-administration', 'timeFrame': 'month 3', 'description': 'percent of travoprost compared to baseline in explanted implant 3 months post-administration as assessed by HPLC'}, {'measure': 'Percent Residual Travoprost in Explanted Implant 6 Months Post-administration', 'timeFrame': 'month 6', 'description': 'percent of travoprost compared to baseline in explanted implant 6 months post-administration as assessed by HPLC'}, {'measure': 'Percent Residual Travoprost in Explanted Implant 24 Months Post-administration', 'timeFrame': 'month 24', 'description': 'percent of travoprost compared to baseline in explanted implant 24 months post-administration as assessed by HPLC'}, {'measure': 'Percent Residual Travoprost in Explanted Implant 21 Months Post-administration', 'timeFrame': 'month 21', 'description': 'percent of travoprost compared to baseline in explanted implant 21 months post-administration as assessed by HPLC'}, {'measure': 'Percent Residual Travoprost in Explanted Implant 18 Months Post-administration', 'timeFrame': 'month 18', 'description': 'percent of travoprost compared to baseline in explanted implant 18 months post-administration as assessed by HPLC'}, {'measure': 'Percent Residual Travoprost in Explanted Implant 15 Months Post-administration', 'timeFrame': 'month 15', 'description': 'percent of travoprost compared to baseline in explanted implant 15 months post-administration as assessed by HPLC'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glaucoma, Open-Angle', 'Ocular Hypertension']}, 'referencesModule': {'references': [{'pmid': '40126812', 'type': 'DERIVED', 'citation': 'Szekely G, Voskanyan LA, Stephens KG, Doan LV, Seal JR, ElMallah MK, Fjield T, Applegate D, Usner DW, Katz LJ, Kothe AC, Navratil T. Aqueous Humor Concentrations of Travoprost Free Acid and Residual Drug in Explanted Implants from Patients Administered a Travoprost Intracameral Implant. Ophthalmol Ther. 2025 May;14(5):989-1003. doi: 10.1007/s40123-025-01130-1. Epub 2025 Mar 24.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the performance of the Travoprost Intracameral Implant by determining residual drug in explanted implants of the Travoprost Intracameral Implant and by determining aqueous humor concentrations of travoprost free acid at specified timepoints post administration through 24 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of either open angle glaucoma (i.e. primary, pseudoexfoliation, or pigmentary glaucoma) or ocular hypertenson\n* Zero to three topical intraocular pressure lowering medications at the time of Visit 1 (Screening) exam.\n* Best spectacle corrected visual acuity of 16 letters or more correctly read at 4 meters or better in each eye.\n* Open angle as defined by Shaffer grade ≥ 3 at slit-lamp at the planned implantation site\n\nExclusion Criteria:\n\n* Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders\n* Active ocular inflammation, infection or edema\n* Clinically significant dystrophy (e.g., bullous keratopathy, Fuch's dystrophy) or clinically significant guttata"}, 'identificationModule': {'nctId': 'NCT06582732', 'briefTitle': 'Performance of the Travoprost Intraocular Implant', 'organization': {'class': 'INDUSTRY', 'fullName': 'Glaukos Corporation'}, 'officialTitle': 'Prospective, Non-Randomized, Open-Label, Single Center Study to Evaluate the Performance of the Travoprost Intraocular Implant', 'orgStudyIdInfo': {'id': 'IDOS-402-IVIV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1 (12-month exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 12', 'interventionNames': ['Drug: Travoprost Intracameral Implant exchanged at Month 12']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2 (3-month exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 3', 'interventionNames': ['Drug: Travoprost Intracameral Implant exchanged at Month 3']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3 (6-month exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 6', 'interventionNames': ['Drug: Travoprost Intracameral Implant exchanged at Month 6']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4 (24-month exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 24', 'interventionNames': ['Drug: Travoprost Intracameral Implant exchanged at Month 24']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 5 (21-month exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 21', 'interventionNames': ['Drug: Travoprost intracameral implant exchanged at Month 21']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 6 (18-month exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 18', 'interventionNames': ['Drug: Travoprost intracameral implant exchanged at Month 18']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 7 (15-month exchange)', 'description': 'Travoprost Intracameral Implant Exchanged at Month 15', 'interventionNames': ['Drug: Travoprost intracameral implant exchanged at Month 15']}], 'interventions': [{'name': 'Travoprost Intracameral Implant exchanged at Month 12', 'type': 'DRUG', 'otherNames': ['iDose TR'], 'description': 'intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12', 'armGroupLabels': ['Cohort 1 (12-month exchange)']}, {'name': 'Travoprost Intracameral Implant exchanged at Month 3', 'type': 'DRUG', 'otherNames': ['iDose TR'], 'description': 'intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 3', 'armGroupLabels': ['Cohort 2 (3-month exchange)']}, {'name': 'Travoprost Intracameral Implant exchanged at Month 6', 'type': 'DRUG', 'otherNames': ['iDose TR'], 'description': 'intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 6', 'armGroupLabels': ['Cohort 3 (6-month exchange)']}, {'name': 'Travoprost Intracameral Implant exchanged at Month 24', 'type': 'DRUG', 'otherNames': ['iDose TR'], 'description': 'intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 24', 'armGroupLabels': ['Cohort 4 (24-month exchange)']}, {'name': 'Travoprost intracameral implant exchanged at Month 21', 'type': 'DRUG', 'otherNames': ['iDose TR'], 'description': 'intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 21', 'armGroupLabels': ['Cohort 5 (21-month exchange)']}, {'name': 'Travoprost intracameral implant exchanged at Month 18', 'type': 'DRUG', 'otherNames': ['iDose TR'], 'description': 'intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 18', 'armGroupLabels': ['Cohort 6 (18-month exchange)']}, {'name': 'Travoprost intracameral implant exchanged at Month 15', 'type': 'DRUG', 'otherNames': ['iDose TR'], 'description': 'intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 15', 'armGroupLabels': ['Cohort 7 (15-month exchange)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yerevan', 'country': 'Armenia', 'facility': 'Glaukos Clinical Study Site', 'geoPoint': {'lat': 40.17765, 'lon': 44.5126}}], 'overallOfficials': [{'name': 'Kerry Stephens', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Glaukos Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glaukos Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}