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

ZK-LBL-2016-01

To evaluate the safety and efficacy of Levobetaxolol in Chinese patients with glaucoma.

2019-01-04

2021-07-01

2021-07-01

Completed

Early phase I

366

Inclusion Criteria: * Agreed to participate in this clinical trial and informed consent; * Aged 18 to 70 years of age, male or female; * In line with primary open-angle glaucoma diagnostic criteria, IOP ≥18mmHg; * or in compliance with ocular hypertension diagnostic criteria, intraocular pressure\> 21mmHg Exclusion Criteria: * Known or suspected to be allergic to investigational drugs and materials * has been diagnosed with angle-closure glaucoma, absolute glaucoma, glaucoma ciliary body syndrome, secondary glaucoma. * merge various retinal lesions, such as retinal detachment, retinal vein occlusion, retinitis pigmentosa. * merge associated with eye infections or cornea, iris, lens obvious lesions, or one-eyed patients. * During the trial who must wear contact lenses, or nearly three months experts any eye surgery or laser treatment. * Need systemic β-blocker therapy during the study. * with severe kidney disease, or abnormal liver function tests (ALT, AST≥ 1.5 times the upper limit of normal, SCr\> upper limit of normal). * 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.). * merge hyperthyroidism, myasthenia gravis, diabetes, advanced cancer, blood and hematopoietic system diseases, or other serious or progressive disease systems. * associated with neurological and psychiatric disorders * suspect or indeed alcohol, drug abuse history. * pregnancy, lactation or recent fertility planner. * The researchers believe other circumstances were not involved in this trial. * participate in other clinical trials within three months.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 366, 'type': 'ACTUAL'}}

2023-05-12