Levobetaxolol Hydrochloride Eye Drops for Treatment of Primary Open-angle Glaucoma or Ocular Hypertension
Study Details
Study Description
Brief Summary
To evaluate the safety and efficacy of Levobetaxolol in Chinese patients with glaucoma.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Detailed Description
To evaluate the safety and efficacy of Levobetaxolol in Chinese patients with primary open-angle glaucoma or ocular hypertension.
Study Design
Arms and Interventions
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
|
Outcome Measures
Primary Outcome Measures
- Decrease of intraocular pressure at week 8 [8 weeks]
Decrease of intraocular pressure at week 8
Secondary Outcome Measures
- Decrease of intraocular pressure at week 2 [2 weeks]
Decrease of intraocular pressure at week 2
- Decrease of intraocular pressure at week 4 [4 weeks]
Decrease of intraocular pressure at week 4
- Decrease of visual field deficiency at week 8 [8 weeks]
Decrease of visual field deficiency at week 8
- Decrease of nerve fiber layer thickness at week 8 [8 weeks]
Decrease of nerve fiber layer thickness at week 8
- visual acuity test with Snellen chart at week 2 [2 weeks]
visual acuity test with Snellen chart at week 2
- visual acuity test with Snellen chart at week 4 [8 weeks]
visual acuity test with Snellen chart at week 4
- visual acuity test with Snellen chart at week 8 [8 weeks]
visual acuity test with Snellen chart at week 8
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Agreed to participate in this clinical trial and informed consent;
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Aged 18 to 70 years of age, male or female;
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In line with primary open-angle glaucoma diagnostic criteria, IOP ≥18mmHg;
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or in compliance with ocular hypertension diagnostic criteria, intraocular pressure> 21mmHg
Exclusion Criteria:
-
Known or suspected to be allergic to investigational drugs and materials
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has been diagnosed with angle-closure glaucoma, absolute glaucoma, glaucoma ciliary body syndrome, secondary glaucoma.
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merge various retinal lesions, such as retinal detachment, retinal vein occlusion, retinitis pigmentosa.
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merge associated with eye infections or cornea, iris, lens obvious lesions, or one-eyed patients.
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During the trial who must wear contact lenses, or nearly three months experts any eye surgery or laser treatment.
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Need systemic β-blocker therapy during the study.
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with severe kidney disease, or abnormal liver function tests (ALT, AST≥ 1.5 times the upper limit of normal, SCr> upper limit of normal).
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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.).
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merge hyperthyroidism, myasthenia gravis, diabetes, advanced cancer, blood and hematopoietic system diseases, or other serious or progressive disease systems.
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associated with neurological and psychiatric disorders
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suspect or indeed alcohol, drug abuse history.
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pregnancy, lactation or recent fertility planner.
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The researchers believe other circumstances were not involved in this trial.
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participate in other clinical trials within three months.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Zhongshan ophthalmic center, Sun Yat-sen University | Guangzhou | Guangdong | China | 510060 |
Sponsors and Collaborators
- Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Investigators
- Principal Investigator: Jian Ge, MD, Zhongshan Ophthalmic Center, Sun Yat-sen University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Zhaoke-201506-Levobetaxolol