Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-12 @ 12:54 PM
Study NCT ID:
NCT02863705
Status:
COMPLETED
Last Update Posted:
2018-08-31
First Post:
2016-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of COMBIGAN® in Korean Patients With Primary Open Angle Glaucoma (POAG) and Normal Tension Glaucoma (NTG)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D057066', 'term': 'Low Tension Glaucoma'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D009901', 'term': 'Optic Nerve Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068438', 'term': 'Brimonidine Tartrate'}], 'ancestors': [{'id': 'D011810', 'term': 'Quinoxalines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-28', 'studyFirstSubmitDate': '2016-05-02', 'studyFirstSubmitQcDate': '2016-08-10', 'lastUpdatePostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean IOP change from Baseline (11AM point)', 'timeFrame': 'Baseline, Month 12'}], 'secondaryOutcomes': [{'measure': 'Mean IOP change from Baseline (11AM point)', 'timeFrame': 'Baseline, Month 12', 'description': 'Mean IOP change from baseline (11AM point) in the following patient sub-groups\n\n1. patients with NTG\n2. patients with POAG\n3. patients taking Combigan alone\n4. patients taking Combigan plus additional Lumigan 0.01%'}, {'measure': 'Mean IOP change from Baseline (9AM point)', 'timeFrame': 'Baseline, Month 12', 'description': 'Mean IOP change from baseline (9AM point) in the following patient sub-groups\n\n1. patients with NTG\n2. patients with POAG\n3. patients taking Combigan alone\n4. patients taking Combigan plus additional Lumigan 0.01%'}, {'measure': 'Mean change in Mean deviation (MD) from Baseline', 'timeFrame': 'Baseline, Month 12'}, {'measure': 'Mean change in Pattern standard deviation (PSD) from Baseline', 'timeFrame': 'Baseline, Month 12'}, {'measure': 'Mean change in Visual field index (VFI) from Baseline', 'timeFrame': 'Baseline, Month 12'}, {'measure': 'Mean change in cup to disc ratio (C/D ratio) from Baseline', 'timeFrame': 'Baseline, Month 12'}, {'measure': 'Rate of VF progression measured as change in VF index over time', 'timeFrame': 'Baseline, Month 12', 'description': 'Rate of VF progression during 12 months in the following patient sub-groups.\n\n1. patients with NTG\n2. patients with POAG\n3. patients taking Combigan alone\n4. patients taking Combigan plus additional Lumigan 0.01%'}, {'measure': 'Mean duration of achieving the target IOP with COMBIGAN® alone', 'timeFrame': '12 Months'}, {'measure': 'The percentage of subjects of achieving the target IOP with COMBIGAN® alone during 12 months', 'timeFrame': '12 Months'}, {'measure': 'Definition of patient demographics (descriptive analysis of age and gender)', 'timeFrame': 'Baseline, Month 12', 'description': 'Define patient demographics in the following patient sub-groups:\n\n1. patients with NTG\n2. patients with POAG\n3. patients taking Combigan alone\n4. patients taking Combigan plus additional Lumigan 0.01%'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glaucoma, Open-Angle', 'Normal Tension Glaucoma']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the long-term efficacy and safety of COMBIGAN® (brimonidine tartrate/timolol malate) in patients only using COMBIGAN® (brimonidine tartrate/timolol malate) and also in patients who require additional IOP lowering with LUMIGAN® (bimatoprost) 0.01%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Primary open angle glaucoma (Regardless of Intraocular pressure)\n* Previous history of topical beta-blocker use and insufficiently controlled IOP\n\nExclusion Criteria:\n\n* Pigmentary or exfoliative glaucoma\n* History of angle-closure or an occludable angle by gonioscopy\n* Prior filtration or laser iridotomy\n* Argon laser trabeculoplasty or Selective laser trabeculoplasty performed less than 6 months\n* History or signs of chronic inflammatory eye disease, ocular trauma, or potentially progressive retinal disease'}, 'identificationModule': {'nctId': 'NCT02863705', 'briefTitle': 'Efficacy and Safety of COMBIGAN® in Korean Patients With Primary Open Angle Glaucoma (POAG) and Normal Tension Glaucoma (NTG)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'officialTitle': 'A 12-Month, Phase 4, Open Label, Multicenter, Trial to Assess the Efficacy and Safety of COMBIGAN® in Korean Patients With Primary Open Angle Glaucoma (POAG) and Normal Tension Glaucoma (NTG)', 'orgStudyIdInfo': {'id': 'CMO-AP-EYE-0428'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'COMBIGAN®', 'description': 'One drop of COMBIGAN® in the affected eye, administered twice daily for 12 months', 'interventionNames': ['Drug: brimonidine tartrate/timolol malate Ophthalmic Solution']}, {'type': 'EXPERIMENTAL', 'label': 'COMBIGAN® + LUMIGAN® 0.01%', 'description': 'LUMIGAN® will be administered once daily in the evening 5 minutes after COMBIGAN® instillation in patients who require additional IOP lowering.', 'interventionNames': ['Drug: brimonidine tartrate/timolol malate Ophthalmic Solution', 'Drug: bimatoprost ophthalmic solution 0.01%']}], 'interventions': [{'name': 'brimonidine tartrate/timolol malate Ophthalmic Solution', 'type': 'DRUG', 'description': 'One drop of brimonidine tartrate/timolol malate (COMBIGAN®) Ophthalmic Solution in the affected eye, administered twice daily for 12 months', 'armGroupLabels': ['COMBIGAN®', 'COMBIGAN® + LUMIGAN® 0.01%']}, {'name': 'bimatoprost ophthalmic solution 0.01%', 'type': 'DRUG', 'description': 'Bimatoprost ophthalmic solution 0.01% (LUMIGAN®) administered once daily in the evening 5 minutes after COMBIGAN® instillation if additional lowering IOP is needed', 'armGroupLabels': ['COMBIGAN® + LUMIGAN® 0.01%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49241', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Pusan National University Hospital, Pusan National University School of Medicine', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '42415', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Yeungnam University Hospital, Yeungnam University College of Medicine', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '35015', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Chungnam National University Hospital, Chungnam National University College of Medicine', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '61469', 'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Chonnam National University Hospital, Chonnam National University Medical School', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '13619', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital, Seoul National University College of Medicine', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital, Seoul National University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03181', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kangbuk Samsung Medical Center, Sungkyunkwan University School of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06591', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Seoul St. Mary's Hospital, The Catholic University of Korea College of Medicine", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '07301', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Kim's Eye Hospital, Konyang University College of Medicine", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Joy Maglambayan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}