Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-29 @ 8:25 AM
Study NCT ID:
NCT01284166
Status:
WITHDRAWN
Last Update Posted:
2013-07-18
First Post:
2011-01-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Triple Combination Therapy With Dorzolamide Hydrochloride / Brimonidine Tartrate / Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['India']}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C062765', 'term': 'dorzolamide'}, {'id': 'D000068438', 'term': 'Brimonidine Tartrate'}, {'id': 'D013999', 'term': 'Timolol'}, {'id': 'D009883', 'term': 'Ophthalmic Solutions'}], 'ancestors': [{'id': 'D011810', 'term': 'Quinoxalines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013830', 'term': 'Thiadiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D019999', 'term': 'Pharmaceutical Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study was never initiated due to company decision. No study subjects were ever enrolled or treated.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2014-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-07-17', 'studyFirstSubmitDate': '2011-01-25', 'studyFirstSubmitQcDate': '2011-01-25', 'lastUpdatePostDateStruct': {'date': '2013-07-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Intraocular Pressure (IOP)', 'timeFrame': 'Baseline, Week 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Glaucoma', 'Ocular Hypertension']}, 'descriptionModule': {'briefSummary': 'This study will investigate the safety and efficacy of Triple Combination Therapy with dorzolamide hydrochloride/brimonidine tartrate/timolol ophthalmic solution in patients with glaucoma or ocular hypertension who have elevated IOP on dorzolamide hydrochloride/timolol maleate combination therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of ocular hypertension or glaucoma in each eye\n* Requires IOP-lowering treatment in both eyes\n\nExclusion Criteria:\n\n* Use of dorzolamide or carbonic anhydrase within 4 weeks\n* Any other active ocular disease other than ocular hypertension or glaucoma (eg, uveitis, ocular infections or severe dry eye)\n* Required chronic use of ocular medications other than study medication during the study (intermittent use of certain products eg, artificial tears are permitted)\n* Use of oral, injectable or topical ophthalmic steroids within 21 days\n* Any eye laser surgery within 3 months\n* Any intraocular surgery (eg cataract surgery) within 6 months'}, 'identificationModule': {'nctId': 'NCT01284166', 'briefTitle': 'Safety and Efficacy of Triple Combination Therapy With Dorzolamide Hydrochloride / Brimonidine Tartrate / Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': 'Dorzo-Brimo-Timo/2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Triple Combination Therapy', 'description': 'Triple Combination Therapy with dorzolamide hydrochloride/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.', 'interventionNames': ['Drug: dorzolamide hydrochloride 2.0%/brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution']}], 'interventions': [{'name': 'dorzolamide hydrochloride 2.0%/brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution', 'type': 'DRUG', 'description': '1 drop of Triple Combination Therapy (dorzolamide hydrochloride 2.0%/brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution) administered to each eye, twice daily for 12 weeks.', 'armGroupLabels': ['Triple Combination Therapy']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}