Ignite Creation Date:
2025-12-24 @ 2:48 PM
Ignite Modification Date:
2026-02-23 @ 6:29 AM
Study NCT ID:
NCT02617459
Status:
COMPLETED
Last Update Posted:
2023-05-12
First Post:
2015-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Levobetaxolol Hydrochloride Eye Drops for Treatment of Primary 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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 366}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-10', 'studyFirstSubmitDate': '2015-11-18', 'studyFirstSubmitQcDate': '2015-11-30', 'lastUpdatePostDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in intraocular pressure (IOP) from baseline at week 8 after the treatment (a.m.)', 'timeFrame': '8 weeks', 'description': 'Change in intraocular pressure (IOP) from baseline at week 8 after the treatment (a.m.)'}], 'secondaryOutcomes': [{'measure': 'Change in intraocular pressure (IOP) from baseline to week 2', 'timeFrame': '2 weeks', 'description': 'Change in intraocular pressure (IOP) from baseline to week 2'}, {'measure': 'Change in intraocular pressure (IOP) from baseline to week 4', 'timeFrame': '4 weeks', 'description': 'Change in intraocular pressure (IOP) from baseline to week 4'}, {'measure': 'Change in intraocular pressure (IOP) from baseline to week 8 (p.m.)', 'timeFrame': '8 weeks', 'description': 'Change in intraocular pressure (IOP) from baseline to week 8 (p.m.)'}, {'measure': 'Change from baseline in mean visual field defect (MD) at 8 weeks after the treatment', 'timeFrame': '8 weeks', 'description': 'Change from baseline in mean visual field defect (MD) at 8 weeks after the treatment'}, {'measure': 'Change in visual field pattern standard deviation (PSD) from baseline at 8 weeks after the treatment', 'timeFrame': '8 weeks', 'description': 'Change in visual field pattern standard deviation (PSD) from baseline at 8 weeks after the treatment'}, {'measure': 'Change in retinal nerve fiber layer (RNFL) thickness from baseline at 8 weeks after the treatment', 'timeFrame': '8 weeks', 'description': 'Change in retinal nerve fiber layer (RNFL) thickness from baseline at 8 weeks after the treatment'}, {'measure': 'Change in visual acuity test at week 2', 'timeFrame': '2 weeks', 'description': 'Change in visual acuity test at week 2'}, {'measure': 'Change in visual acuity test at week 4', 'timeFrame': '4 weeks', 'description': 'Change in visual acuity test at week 4'}, {'measure': 'Change in visual acuity test at week 8', 'timeFrame': '8 weeks', 'description': 'Change in visual acuity test at week 8'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Safety', 'efficacy', 'Levobetaxolol eye drops', 'Chinese patients'], 'conditions': ['Primary Open-angle Glaucoma', 'Ocular Hypertension']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and efficacy of Levobetaxolol in Chinese patients with glaucoma.', 'detailedDescription': 'To evaluate the safety and efficacy of Levobetaxolol in Chinese patients with primary open-angle glaucoma or ocular hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Agreed to participate in this clinical trial and informed consent;\n* Aged 18 to 70 years of age, male or female;\n* In line with primary open-angle glaucoma diagnostic criteria, IOP ≥18mmHg;\n* or in compliance with ocular hypertension diagnostic criteria, intraocular pressure\\> 21mmHg\n\nExclusion Criteria:\n\n* Known or suspected to be allergic to investigational drugs and materials\n* has been diagnosed with angle-closure glaucoma, absolute glaucoma, glaucoma ciliary body syndrome, secondary glaucoma.\n* merge various retinal lesions, such as retinal detachment, retinal vein occlusion, retinitis pigmentosa.\n* merge associated with eye infections or cornea, iris, lens obvious lesions, or one-eyed patients.\n* During the trial who must wear contact lenses, or nearly three months experts any eye surgery or laser treatment.\n* Need systemic β-blocker therapy during the study.\n* with severe kidney disease, or abnormal liver function tests (ALT, AST≥ 1.5 times the upper limit of normal, SCr\\> upper limit of normal).\n* merge sinus bradycardia, over Ⅰ degree atrioventricular block, cardiogenic shock, heart failure, symptomatic hypotension or other serious heart, lung diseases (such as bronchial asthma or a history of bronchial asthma, chronic obstructive lung disease, bronchospasm, respiratory failure, etc.).\n* merge hyperthyroidism, myasthenia gravis, diabetes, advanced cancer, blood and hematopoietic system diseases, or other serious or progressive disease systems.\n* associated with neurological and psychiatric disorders\n* suspect or indeed alcohol, drug abuse history.\n* pregnancy, lactation or recent fertility planner.\n* The researchers believe other circumstances were not involved in this trial.\n* participate in other clinical trials within three months.'}, 'identificationModule': {'nctId': 'NCT02617459', 'briefTitle': 'Levobetaxolol Hydrochloride Eye Drops for Treatment of Primary Open-angle Glaucoma or Ocular Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.'}, 'officialTitle': 'A Multicenter, Randomized, Open-label, Positive-controlled, Parallel-group Clinical Trial of Levobetaxolol Hydrochloride Eye Drops in Patients With Primary Open-angle Glaucoma or Ocular Hypertension', 'orgStudyIdInfo': {'id': 'ZK-LBL-2016-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Levobetaxolol eye drops', 'description': 'Levobetaxolol eye drops 5ml/25mg per bottle', 'interventionNames': ['Drug: Levobetaxolol eye drops']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Betaxolol eye drops', 'description': 'Betaxolol eye drops 5ml/12.5mg per bottle', 'interventionNames': ['Drug: Betaxolol eye drops']}], 'interventions': [{'name': 'Levobetaxolol eye drops', 'type': 'DRUG', 'description': 'one drop per time; twice daily', 'armGroupLabels': ['Levobetaxolol eye drops']}, {'name': 'Betaxolol eye drops', 'type': 'DRUG', 'description': 'one drop per time; twice daily', 'armGroupLabels': ['Betaxolol eye drops']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Zhongshan ophthalmic center, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Jian Ge, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}