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

Ocular Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02617459
• Other study ID #: ZK-LBL-2016-01
• Status: Completed
• Phase: Phase 3
• Start date: January 4, 2019
• Est. completion date: July 1, 2021

Study information

• Verified date: May 2023
• Source: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 366
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 ß-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 ? 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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Primary Open-angle Glaucoma

Intervention

Drug:
• Levobetaxolol eye drops
one drop per time; twice daily
• Betaxolol eye drops
one drop per time; twice daily

Locations

Country	Name	City	State
China	Zhongshan ophthalmic center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in intraocular pressure (IOP) from baseline to week 2	Change in intraocular pressure (IOP) from baseline to week 2	2 weeks
Secondary	Change in intraocular pressure (IOP) from baseline to week 4	Change in intraocular pressure (IOP) from baseline to week 4	4 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in visual acuity test at week 2	Change in visual acuity test at week 2	2 weeks
Secondary	Change in visual acuity test at week 4	Change in visual acuity test at week 4	4 weeks
Secondary	Change in visual acuity test at week 8	Change in visual acuity test at week 8	8 weeks