Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT07075718
Status:
RECRUITING
Last Update Posted:
2025-07-22
First Post:
2025-07-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 2/Phase 3 Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 610}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2032-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-18', 'studyFirstSubmitDate': '2025-07-10', 'studyFirstSubmitQcDate': '2025-07-10', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular pressure (IOP)', 'timeFrame': '3 months', 'description': 'Change from baseline in diurnal IOP in the study eye at 8AM and 10AM at each of Day 11, Week 6, and Month 3 visits'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['open-angle glaucoma', 'ocular hypertension'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant', 'detailedDescription': 'Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant Compared to Timolol Ophthalmic Solution 0.5% Administered Twice Daily in Subjects with Open-Angle Glaucoma or Ocular Hypertension'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of open-angle glaucoma or ocular hypertension in the study eye\n\nExclusion Criteria:\n\n* Prior incisional glaucoma surgery in the study eye\n* Prior argon laser trabeculoplasty (ALT) in the study eye\n* Prior minimally invasive glaucoma (MIGS) surgery in the study eye'}, 'identificationModule': {'nctId': 'NCT07075718', 'briefTitle': 'Phase 2/Phase 3 Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant', 'organization': {'class': 'INDUSTRY', 'fullName': 'Glaukos Corporation'}, 'officialTitle': 'Phase 2/Phase 3 Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant', 'orgStudyIdInfo': {'id': 'GLK-102-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Period 1 (Cohort A)', 'description': 'Single-arm, open-label portion of Phase 2; subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and be followed for 36 months', 'interventionNames': ['Drug: Gen 2 Travoprost Intracameral Implant']}, {'type': 'EXPERIMENTAL', 'label': 'Period 2 (Cohort B) Gen 2 Travoprost Intracameral Implant Arm', 'description': 'Randomized, double-masked, active-controlled Phase 2 portion of the trial; subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and be followed for 36 months', 'interventionNames': ['Drug: Gen 2 Travoprost Intracameral Implant', 'Other: Placebo eye drops']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Period 2 (Cohort B) Timolol Arm', 'description': 'Randomized, double-masked, active-controlled, Phase 2 portion of the trial; subjects will administer timolol 0.5% eye drops BID (plus sham procedure) in the study eye and be followed for 36 months', 'interventionNames': ['Drug: Timolol eye drops 0.5%', 'Procedure: Sham Procedure']}, {'type': 'EXPERIMENTAL', 'label': 'Period 3 (Cohort X) Gen 2 Travoprost Intracameral Implant Arm', 'description': 'Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and undergo an exchange procedure at month 12 and be followed for an additional 12 months', 'interventionNames': ['Drug: Gen 2 Travoprost Intracameral Implant', 'Other: Placebo eye drops']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Period 3 (Cohort X) Timolol Arm', 'description': 'Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will administer timolol 0.5% eye drops BID (plus sham procedure) in the study eye and undergo a sham exchange procedure at month 12 and be followed for an additional 12 months', 'interventionNames': ['Drug: Timolol eye drops 0.5%', 'Procedure: Sham Procedure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Period 3 (Cohort Y) Gen 2 Travoprost Intracameral Implant Arm', 'description': 'Randomized, double-masked, active-controlled, Phase 3 portion of the trial, subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and undergo an exchange procedure at month 24 and be followed for an additional 12 months', 'interventionNames': ['Drug: Gen 2 Travoprost Intracameral Implant', 'Other: Placebo eye drops']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Period 3 (Cohort Y) Timolol Arm', 'description': 'Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will receive timolol 0.5% eye drops BID (plus sham procedure) in the study eye and undergo a sham exchange procedure at month 24 and be followed for an additional 12 months', 'interventionNames': ['Drug: Timolol eye drops 0.5%', 'Procedure: Sham Procedure']}, {'type': 'EXPERIMENTAL', 'label': 'Period 3 (Cohort Z) Gen 2 Travoprost Intracameral Implant Arm', 'description': 'Randomized, double-masked, active-controlled, Phase 3 portion of the trial, subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and undergo an exchange procedure at month 36 and be followed for an additional 12 months', 'interventionNames': ['Drug: Gen 2 Travoprost Intracameral Implant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Period 3 (Cohort Z) Timolol Arm', 'description': 'Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will administer timolol 0.5% eye drops BID (plus sham procedure) in the study eye and undergo an sham exchange procedure at month 36 and be followed for an additional 12 months', 'interventionNames': ['Drug: Timolol eye drops 0.5%', 'Other: Placebo eye drops']}], 'interventions': [{'name': 'Gen 2 Travoprost Intracameral Implant', 'type': 'DRUG', 'otherNames': ['Gen 2 Travoprost Intraocular Implant'], 'description': 'travoprost', 'armGroupLabels': ['Period 1 (Cohort A)', 'Period 2 (Cohort B) Gen 2 Travoprost Intracameral Implant Arm', 'Period 3 (Cohort X) Gen 2 Travoprost Intracameral Implant Arm', 'Period 3 (Cohort Y) Gen 2 Travoprost Intracameral Implant Arm', 'Period 3 (Cohort Z) Gen 2 Travoprost Intracameral Implant Arm']}, {'name': 'Timolol eye drops 0.5%', 'type': 'DRUG', 'otherNames': ['Timolol maleate ophthalmic solution, 0.5%'], 'description': 'timolol 0.5%', 'armGroupLabels': ['Period 2 (Cohort B) Timolol Arm', 'Period 3 (Cohort X) Timolol Arm', 'Period 3 (Cohort Y) Timolol Arm', 'Period 3 (Cohort Z) Timolol Arm']}, {'name': 'Sham Procedure', 'type': 'PROCEDURE', 'description': 'sham implant administration', 'armGroupLabels': ['Period 2 (Cohort B) Timolol Arm', 'Period 3 (Cohort X) Timolol Arm', 'Period 3 (Cohort Y) Timolol Arm']}, {'name': 'Placebo eye drops', 'type': 'OTHER', 'description': 'artificial tears', 'armGroupLabels': ['Period 2 (Cohort B) Gen 2 Travoprost Intracameral Implant Arm', 'Period 3 (Cohort X) Gen 2 Travoprost Intracameral Implant Arm', 'Period 3 (Cohort Y) Gen 2 Travoprost Intracameral Implant Arm', 'Period 3 (Cohort Z) Timolol Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81501', 'city': 'Grand Junction', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'email': 'idoseclinical@glaukos.com', 'phone': '949-739-8749'}], 'facility': 'Glaukos Investigative Site', 'geoPoint': {'lat': 39.06387, 'lon': -108.55065}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'email': 'idoseclinical@glaukos.com', 'phone': '949-739-8749'}], 'facility': 'Glaukos Investigative Site', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '79922', 'city': 'El Paso', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'email': 'idoseclinical@glaukos.com', 'phone': '949-739-8749'}], 'facility': 'Glaukos Clinical Site', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}], 'centralContacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'idoseclinical@glaukos.com', 'phone': '949-739-8749'}], 'overallOfficials': [{'name': 'Luis G. Vargas, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Glaukos Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glaukos Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}