Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-31 @ 10:58 PM
Study NCT ID:
NCT00670033
Status:
COMPLETED
Last Update Posted:
2014-07-10
First Post:
2008-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Travoprost New Formulations in Patients With Open-Angle Glaucoma or Ocular Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D005901', 'term': 'Glaucoma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069557', 'term': 'Travoprost'}], 'ancestors': [{'id': 'D003008', 'term': 'Cloprostenol'}, {'id': 'D011461', 'term': 'Prostaglandins F, Synthetic'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'dispFirstSubmitDate': '2014-07-09', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-09', 'studyFirstSubmitDate': '2008-04-29', 'dispFirstSubmitQcDate': '2014-07-09', 'studyFirstSubmitQcDate': '2008-04-30', 'dispFirstPostDateStruct': {'date': '2014-07-10', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change from baseline in intraocular pressure (IOP)', 'timeFrame': 'Baseline, Up to Week 4', 'description': 'IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement.'}], 'secondaryOutcomes': [{'measure': 'Mean intraocular pressure', 'timeFrame': 'Baseline, Up to Week 4', 'description': 'IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage).'}, {'measure': 'Mean percent change from baseline in IOP', 'timeFrame': 'Baseline, Up to Week 4', 'description': 'IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative percent change indicates a greater amount of improvement.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['IOP', 'Open-angle glaucoma', 'Ocular Hypertension'], 'conditions': ['Ocular Hypertension', 'Open-angle Glaucoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to describe the safety and IOP-lowering efficacy of Travoprost New Formulations compared to TRAVATAN® and to vehicle in patients with open-angle glaucoma or ocular hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Satisfy all informed consent requirements;\n* Diagnosed with open-angle glaucoma or ocular hypertension;\n* Able to discontinue use of all IOP-lowering medications for a minimum of 5 to 28 days prior to the Eligibility 1 Visit;\n* IOP measurements in at least 1 eye as specified in protocol;\n* Other protocol-specified inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Females of childbearing potential if pregnant, breastfeeding, or not using highly effective birth control measures;\n* Any form of glaucoma other than open-angle glaucoma;\n* Severe central visual field loss in either eye;\n* Chronic, recurrent or severe inflammatory eye disease;\n* Clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment, in the opinion of the Investigator;\n* Best-corrected visual acuity (BCVA) worse than 0.60 logarithm of the miniminum angle of resolution (logMAR);\n* Intraocular surgery within the past 6 months;\n* Ocular laser surgery within the past 3 months;\n* Any abnormality preventing reliable applanation tonometry;\n* Severe illness or any other conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study;\n* Other protocol-specified exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00670033', 'briefTitle': 'Travoprost New Formulations in Patients With Open-Angle Glaucoma or Ocular Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Comparison of Safety and IOP-Lowering Efficacy of Three Alternative Travoprost Formulations to Vehicle and TRAVATAN® in Patients With Open-Angle Glaucoma or Ocular Hypertension', 'orgStudyIdInfo': {'id': 'C-07-46'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Travoprost new formulation', 'description': 'Travoprost ophthalmic solution (new formulation), 1 of 3 dose levels, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks', 'interventionNames': ['Drug: Travoprost ophthalmic solution (new formulation)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TRAVATAN', 'description': 'Travoprost ophthalmic solution 0.004%, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks', 'interventionNames': ['Drug: Travoprost ophthalmic solution, 0.004%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': 'Inactive ingredients, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks', 'interventionNames': ['Drug: Vehicle']}], 'interventions': [{'name': 'Travoprost ophthalmic solution (new formulation)', 'type': 'DRUG', 'armGroupLabels': ['Travoprost new formulation']}, {'name': 'Travoprost ophthalmic solution, 0.004%', 'type': 'DRUG', 'otherNames': ['TRAVATAN®', 'TRAVATAN Z®'], 'armGroupLabels': ['TRAVATAN']}, {'name': 'Vehicle', 'type': 'DRUG', 'description': 'Inactive ingredients used as a placebo', 'armGroupLabels': ['Vehicle']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Theresa Landry, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}