Ocular Hypertension, Primary Open-angle Glaucoma
Conditions
Keywords
Safety, efficacy, Levobetaxolol eye drops, Chinese patients
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.
Interventions
DRUGLevobetaxolol eye drops
one drop per time; twice daily
DRUGBetaxolol eye drops
one drop per time; twice daily
Sponsors
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
| Change in intraocular pressure (IOP) from baseline to week 2 | 2 weeks | Change in intraocular pressure (IOP) from baseline to week 2 |
| 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 4 | 4 weeks | Change in visual acuity test at week 4 |
| Change in visual acuity test at week 8 | 8 weeks | Change in visual acuity test at week 8 |
| 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 |
Countries
China
Outcome results
None listed