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

NCT ID: NCT02617459

Last Updated: 2023-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 366 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-04
• Study Completion Date: 2021-07-01

Brief Summary

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

Detailed Description

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

Conditions

Primary Open-angle Glaucoma; Ocular Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Levobetaxolol eye drops

Levobetaxolol eye drops 5ml/25mg per bottle

Group Type: EXPERIMENTAL

Levobetaxolol eye drops

Intervention Type: DRUG

one drop per time; twice daily

Betaxolol eye drops

Betaxolol eye drops 5ml/12.5mg per bottle

Group Type: ACTIVE_COMPARATOR

Betaxolol eye drops

Intervention Type: DRUG

one drop per time; twice daily

Interventions

Levobetaxolol eye drops

one drop per time; twice daily

Intervention Type: DRUG

Betaxolol eye drops

one drop per time; twice daily

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jian Ge, MD

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

Zhongshan ophthalmic center, Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

ZK-LBL-2016-01

Identifier Type: -

Identifier Source: org_study_id