Last updated: May 10, 2023
Sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Overall Status: Completed
Phase
3
Condition
Glaucoma
Ocular Hypertension
Stress
Treatment
Levobetaxolol eye drops
Betaxolol eye drops
Clinical Study ID
NCT02617459
ZK-LBL-2016-01
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
Exclusion Criteria:
- Known or suspected to be allergic to investigational drugs and materials
- has been diagnosed with angle-closure glaucoma, absolute glaucoma, glaucoma ciliarybody 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, orone-eyed patients.
- During the trial who must wear contact lenses, or nearly three months experts any eyesurgery 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 theupper 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 asbronchial asthma or a history of bronchial asthma, chronic obstructive lung disease,bronchospasm, respiratory failure, etc.).
- merge hyperthyroidism, myasthenia gravis, diabetes, advanced cancer, blood andhematopoietic 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.
Study Design
Total Participants: 366
Treatment Group(s): 2
Primary Treatment: Levobetaxolol eye drops
Phase: 3
Study Start date:
January 04, 2019
Estimated Completion Date:
July 01, 2021
Study Description
Connect with a study center
Zhongshan ophthalmic center, Sun Yat-sen University
Guangzhou, Guangdong 510060
ChinaSite Not Available
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