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

Phase 3

Completed

• Conditions: Primary Open-angle Glaucoma; Ocular Hypertension
• Interventions: Drug: Levobetaxolol eye drops; Drug: Betaxolol eye drops

• Registration Number: NCT02617459
• Lead Sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

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.

Study Timeline

• Study First Submitted: 2015-11-18
• Study First Submitted QC: 2015-11-30
• Study First Posted: 2015-12-01
• Study Start: 2019-01-04
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 366

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levobetaxolol eye drops	Levobetaxolol eye drops	Levobetaxolol eye drops 5ml/25mg per bottle
Betaxolol eye drops	Betaxolol eye drops	Betaxolol eye drops 5ml/12.5mg per bottle

Primary Outcome Measures

Name	Time	Method
Change in intraocular pressure (IOP) from baseline at week 8 after the treatment (a.m.)	8 weeks	Change in intraocular pressure (IOP) from baseline at week 8 after the treatment (a.m.)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zhongshan ophthalmic center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China