Ignite Creation Date:
2025-12-24 @ 12:16 PM
Ignite Modification Date:
2025-12-28 @ 2:29 PM
Study NCT ID:
NCT06152861
Status:
UNKNOWN
Last Update Posted:
2023-12-06
First Post:
2023-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Travoprost Ophthalmic Topical Cream for Open-angle Glaucoma or Ocular Hypertension
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-30', 'studyFirstSubmitDate': '2023-11-22', 'studyFirstSubmitQcDate': '2023-11-22', 'lastUpdatePostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change from baseline in mean diurnal IOP in the study eye', 'timeFrame': 'Day 29', 'description': 'Day 29 mean diurnal IOP minus Baseline mean diurnal IOP in the study eye'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Open Angle Glaucoma', 'Ocular Hypertension']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn about the safety of Travoprost Ophthalmic Topical Cream and how well it works in lowering high intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).\n\nA low dose, medium dose and high dose of Travoprost Ophthalmic Topical Cream will be compared to timolol maleate ophthalmic solution, 0.5% and to travoprost ophthalmic solution, 0.004%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, 18 years of age or older at the Screening Visit;\n* Willing and able to provide written informed consent on the IRB/IEC-approved informed consent form;\n* Diagnosis of OAG (including pigmentary and pseudoexfoliative) or OHT in both eyes;\n* Qualifying IOP in the study eye;\n* Best-corrected visual acuity of approximately 20/80 Snellen in each eye\n\nExclusion Criteria:\n\n* Sensitivity or allergy to travoprost or timolol;\n* Bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease;\n* History of or current sinus bradycardia, second- or third-degree atrioventricular block, overt cardiac failure, or cardiogenic shock;\n* History of cerebrovascular insufficiency;\n* Any form of glaucoma other than open-angle glaucoma\n* Advanced visual field loss or cup-to-disc ratio of 0.8 or greater\n* Non-qualifying prior surgeries or procedures in either eye'}, 'identificationModule': {'nctId': 'NCT06152861', 'briefTitle': 'Travoprost Ophthalmic Topical Cream for Open-angle Glaucoma or Ocular Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Glaukos Corporation'}, 'officialTitle': 'Multicenter, Randomized, Double-Masked, Active-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of Travoprost Ophthalmic Topical Cream in Subjects With Open-angle Glaucoma or Ocular Hypertension', 'orgStudyIdInfo': {'id': 'GLK-311-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Travoprost Ophthalmic Topical Cream low-dose', 'description': 'Travoprost Ophthalmic Topical Cream low-dose administered once-daily in the evening for 28 days', 'interventionNames': ['Drug: Travoprost Ophthalmic Topical Cream low-dose']}, {'type': 'EXPERIMENTAL', 'label': 'Travoprost Ophthalmic Topical Cream mid-dose', 'description': 'Travoprost Ophthalmic Topical Cream mid-dose administered once-daily in the evening for 28 days', 'interventionNames': ['Drug: Travoprost Ophthalmic Topical Cream mid-dose']}, {'type': 'EXPERIMENTAL', 'label': 'Travoprost Ophthalmic Topical Cream high-dose', 'description': 'Travoprost Ophthalmic Topical Cream high-dose administered once-daily in the evening for 28 days', 'interventionNames': ['Drug: Travoprost Ophthalmic Topical Cream high-dose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Timolol maleate ophthalmic solution, 0.5%', 'description': 'Timolol maleate ophthalmic solution, 0.5% administered twice daily, morning and evening, for 28 days', 'interventionNames': ['Drug: Timolol maleate ophthalmic solution, 0.5%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Travoprost ophthalmic solution, 0.004%', 'description': 'Travoprost ophthalmic solution, 0.004% administered once daily in the evening for 28 days', 'interventionNames': ['Drug: Travoprost Ophthalmic Solution, 0.004%']}], 'interventions': [{'name': 'Travoprost Ophthalmic Topical Cream low-dose', 'type': 'DRUG', 'description': 'travoprost ophthalmic topical cream low-dose once daily in the evening to both eyes', 'armGroupLabels': ['Travoprost Ophthalmic Topical Cream low-dose']}, {'name': 'Travoprost Ophthalmic Topical Cream mid-dose', 'type': 'DRUG', 'description': 'travoprost ophthalmic topical cream mid-dose once daily in the evening to both eyes', 'armGroupLabels': ['Travoprost Ophthalmic Topical Cream mid-dose']}, {'name': 'Travoprost Ophthalmic Topical Cream high-dose', 'type': 'DRUG', 'description': 'travoprost ophthalmic topical cream high-dose once daily in the evening to both eyes', 'armGroupLabels': ['Travoprost Ophthalmic Topical Cream high-dose']}, {'name': 'Timolol maleate ophthalmic solution, 0.5%', 'type': 'DRUG', 'description': 'timolol maleate ophthalmic solution, 0.5% twice daily (morning \\& evening) to both eyes', 'armGroupLabels': ['Timolol maleate ophthalmic solution, 0.5%']}, {'name': 'Travoprost Ophthalmic Solution, 0.004%', 'type': 'DRUG', 'description': 'travoprost ophthalmic solution, 0.004% once daily in the evening to both eyes', 'armGroupLabels': ['Travoprost ophthalmic solution, 0.004%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Glaukos Study Manager', 'role': 'CONTACT', 'email': 'PBraswell@glaukos.com', 'phone': '949-367-9600'}], 'facility': 'Glaukos Clinical Study Site', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}], 'centralContacts': [{'name': 'Study Clinical Trial Associate', 'role': 'CONTACT', 'email': 'SVea@glaukos.com', 'phone': '949-367-9600'}, {'name': 'Study Manager', 'role': 'CONTACT', 'email': 'PBraswell@glaukos.com', 'phone': '949-367-9600'}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Glaukos Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glaukos Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}