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

Study Overview
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Brief Summary
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To evaluate the safety and efficacy of Levobetaxolol in Chinese patients with glaucoma.

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

Official Title
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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

Conditions
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Primary Open-angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Levobetaxolol eye drops
* Drug: Betaxolol eye drops


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, efficacy, Levobetaxolol eye drops, Chinese patients