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.