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To evaluate the safety and efficacy of Levobetaxolol in Chinese patients with glaucoma.
To evaluate the safety and efficacy of Levobetaxolol in Chinese patients with primary open-angle glaucoma or ocular hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levobetaxolol eye drops | Experimental | Levobetaxolol eye drops 5ml/25mg per bottle |
|
| Betaxolol eye drops | Active Comparator | Betaxolol eye drops 5ml/12.5mg per bottle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levobetaxolol eye drops | Drug | one drop per time; twice daily |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jian Ge, MD | Zhongshan Ophthalmic Center, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan ophthalmic center, Sun Yat-sen University | Guangzhou | Guangdong | 510060 | China |
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| Betaxolol eye drops |
| Drug |
one drop per time; twice daily |
|
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 |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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