Overview

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

Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
0
Participant gender:
All
Summary
To evaluate the safety and efficacy of Levobetaxolol in Chinese patients with glaucoma.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Lee's Pharmaceutical Limited
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Treatments:
Betaxolol
Ophthalmic Solutions
Tetrahydrozoline
Criteria
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.