Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT06061718
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2023-09-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Travoprost Intraocular Implant in Conjunction With Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-30', 'studyFirstSubmitDate': '2023-09-25', 'studyFirstSubmitQcDate': '2023-09-25', 'lastUpdatePostDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in mean diurnal IOP', 'timeFrame': '3 months', 'description': 'Mean diurnal IOP at the Month 3 Visit minus the mean diurnal IOP at the Baseline Visit'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Open Angle Glaucoma', 'Ocular Hypertension']}, 'referencesModule': {'references': [{'pmid': '39959854', 'type': 'DERIVED', 'citation': 'Singh IP, Voskanyan LA, Barber KM, Burden JH, Connolly L, Katz LJ, Usner DW, Kothe AC, Navratil T. Safety and efficacy of travoprost intracameral implant administered in combination with cataract surgery. Ther Adv Ophthalmol. 2025 Feb 14;17:25158414241310275. doi: 10.1177/25158414241310275. eCollection 2025 Jan-Dec.'}]}, 'descriptionModule': {'briefSummary': 'Subjects with cataract requiring extraction and who have open-angle glaucoma or ocular hypertension will undergo screening and washout from IOP-lowering medication, if applicable. Eligible subjects who meet all inclusion criteria and none of the exclusion criteria and who undergo successful cataract extraction with implantation of a posterior chamber intraocular lens (PC-IOL) will receive a travoprost intraocular implant and followed up for 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* clinically significant age-related cataract eligible for phacoemulsification in the study eye\n* open-angle glaucoma or ocular hypertension in the study eye\n* successful, uncomplicated cataract surgery using small incision phacoemulsification cataract surgery and insertion of a foldable posterior chamber IOL\n\nExclusion Criteria:\n\n* unmedicated (washed out) IOP of \\>36 mmHg in the study eye\n* hypersensitivity to travoprost or any other components of the travoprost intraocular implant\n* vertical cup/disc ratio \\> 0.8 in the study eye\n* best spectacle corrected visual acuity of worse than 20/80 in the fellow eye\n* any ocular disease or condition that, in the opinion of the investigator, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study"}, 'identificationModule': {'nctId': 'NCT06061718', 'briefTitle': 'Travoprost Intraocular Implant in Conjunction With Cataract Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Glaukos Corporation'}, 'officialTitle': 'Multicenter, Open-label, Single-arm Trial to Evaluate the Safety and Efficacy of iDose® TR (Travoprost Intraocular Implant) in Conjunction With Cataract Surgery', 'orgStudyIdInfo': {'id': 'GLK-101-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'iDose TR', 'description': 'Travoprost Intraocular Implant administered intracamerally in the study eye at the Day 1 Visit following successful cataract surgery', 'interventionNames': ['Drug: iDose TR']}], 'interventions': [{'name': 'iDose TR', 'type': 'DRUG', 'otherNames': ['travoprost intraocular implant'], 'description': 'anchored intracameral implant containing travoprost', 'armGroupLabels': ['iDose TR']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yerevan', 'country': 'Armenia', 'facility': 'Glaukos Clinical Study Site', 'geoPoint': {'lat': 40.17765, 'lon': 44.5126}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Glaukos Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glaukos Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}