Levobetaxolol Hydrochloride Eye Drops for Treatment of Primary Open-angle Glaucoma or Ocular Hypertension

Zhaoke Ophthalmology

Status and phase

Completed

Phase 3

Conditions

Ocular Hypertension

Primary Open-angle Glaucoma

Treatments

Drug: Levobetaxolol eye drops

Drug: Betaxolol eye drops

Study type

Interventional

Funder types

Industry

Identifiers

ZK-LBL-2016-01

Details and patient eligibility

About

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

Full description

To evaluate the safety and efficacy of Levobetaxolol in Chinese patients with primary open-angle glaucoma or ocular hypertension.

Enrollment

366 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.