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

A Multicenter, Randomized, Open-label, Positive-controlled, Parallel-group Clinical Trial of Levobetaxolol Hydrochloride Eye Drops in Patients With Primary Open-angle Glaucoma or Ocular Hypertension

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

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Primary Open-angle Glaucoma
• Intervention / Treatment: Drug: Levobetaxolol eye drops; Drug: Betaxolol eye drops

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 366
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Zhongshan Ophthalmic Center, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Levobetaxolol eye drops; Levobetaxolol eye drops 5ml/25mg per bottle	Drug: Levobetaxolol eye drops; one drop per time; twice daily
Active Comparator: Betaxolol eye drops; Betaxolol eye drops 5ml/12.5mg per bottle	Drug: Betaxolol eye drops; one drop per time; twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in intraocular pressure (IOP) from baseline at week 8 after the treatment (a.m.)	Change in intraocular pressure (IOP) from baseline at week 8 after the treatment (a.m.)	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in intraocular pressure (IOP) from baseline to week 2	Change in intraocular pressure (IOP) from baseline to week 2	2 weeks
Change in intraocular pressure (IOP) from baseline to week 4	Change in intraocular pressure (IOP) from baseline to week 4	4 weeks
Change in intraocular pressure (IOP) from baseline to week 8 (p.m.)	Change in intraocular pressure (IOP) from baseline to week 8 (p.m.)	8 weeks
Change from baseline in mean visual field defect (MD) at 8 weeks after the treatment	Change from baseline in mean visual field defect (MD) at 8 weeks after the treatment	8 weeks
Change in visual field pattern standard deviation (PSD) from baseline at 8 weeks after the treatment	Change in visual field pattern standard deviation (PSD) from baseline at 8 weeks after the treatment	8 weeks
Change in retinal nerve fiber layer (RNFL) thickness from baseline at 8 weeks after the treatment	Change in retinal nerve fiber layer (RNFL) thickness from baseline at 8 weeks after the treatment	8 weeks
Change in visual acuity test at week 2	Change in visual acuity test at week 2	2 weeks
Change in visual acuity test at week 4	Change in visual acuity test at week 4	4 weeks
Change in visual acuity test at week 8	Change in visual acuity test at week 8	8 weeks

Collaborators and Investigators

• Sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
• Investigators: Principal Investigator: Jian Ge, MD, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2019
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: November 18, 2015
• First Submitted That Met QC Criteria: November 30, 2015
• First Posted (Estimate): December 1, 2015

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Safety; efficacy; Chinese patients; Levobetaxolol eye drops
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Pharmaceutical Solutions; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Ophthalmic Solutions; Betaxolol
• Other Study ID Numbers: ZK-LBL-2016-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No