glaucoma
Conditions
Interventions
intervention group:local eye drop
Sponsors
The Second Affiliated Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged= 18 years; 2. Meeting the diagnostic criteria for primary open-angle glaucoma or ocular hypertension; 3. An IOP >21mmHg for two consecutive measurements or more before treatment of ocular hypertension, without abnormal manifestations of optic nerve, without abnormalities of visual field examination; 4. A diagnosis of open-angle glaucoma that meets abnormalities of visual field examination and / or glaucomatous optic neuropathy; 5. Patients who are willing to sign the Informed Consent Form (ICF).;Inclusion criteria: 1. Aged= 18 years; 2. Meeting the diagnostic criteria for primary open-angle glaucoma or ocular hypertension; 3. An IOP >21mmHg for two consecutive measurements or more before treatment of ocular hypertension, without abnormal manifestations of optic nerve, without abnormalities of visual field examination; 4. A diagnosis of open-angle glaucoma that meets abnormalities of visual field examination and / or glaucomatous optic neuropathy; 5. Patients who are willing to sign the Informed Consent Form (ICF).;Inclusion criteria: 1. Aged= 18 years; 2. Meeting the diagnostic criteria for primary open-angle glaucoma or ocular hypertension; 3. An IOP >21mmHg for two consecutive measurements or more before treatment of ocular hypertension, without abnormal manifestations of optic nerve, without abnormalities of visual field examination; 4. A diagnosis of open-angle glaucoma that meets abnormalities of visual field examination and / or glaucomatous optic neuropathy; 5. Patients who are willing to sign the Informed Consent Form (ICF).;Inclusion criteria: 1. Aged= 18 years; 2. Meeting the diagnostic criteria for primary open-angle glaucoma or ocular hypertension; 3. An IOP >21mmHg for two consecutive measurements or more before treatment of ocular hypertension, without abnormal manifestations of optic nerve, without abnormalities of visual field examination; 4. A diagnosis of open-angle glaucoma that meets abnormalities of visual field examination and / or glaucomatous optic neuropathy; 5. Patients who are willing to sign the Informed Consent Form (ICF).;Inclusion criteria: 1. Aged= 18 years; 2. Meeting the diagnostic criteria for primary open-angle glaucoma or ocular hypertension; 3. An IOP >21mmHg for two consecutive measurements or more before treatment of ocular hypertension, without abnormal manifestations of optic nerve, without abnormalities of visual field examination; 4. A diagnosis of open-angle glaucoma that meets abnormalities of visual field examination and / or glaucomatous optic neuropathy; 5. Patients who are willing to sign the Informed Consent Form (ICF).
Exclusion criteria
Exclusion criteria: 1. Design of time points for IOP and blood pressure monitoring 1.1 Baseline monitoring All of the patients who are using topical drugs for control of pressure inside the eye before initiation of the trial are required to complete a 4-week drug washout period, regardless of the type of IOP-lowering drug used. Patients who are not using IOP-lowering drugs may take the first (baseline) measurement of 24-hour IOP and blood pressure (BP). During each measurement, each of the enrolled patients will be assigned a separate bedroom in the hospital to rest for 24 hours; 1.2 Method of drug administration; The patients will be instructed to apply a drop of the drug to each eye once daily at 21:00 when dispensed with the investigational product. The second 24-hour IOP measurement will be performed after 4 weeks of treatment with the investigational product, and the patients will be instructed to withdraw the investigational product after completion of the measurement; 1.3 Third 24-hour measurement; The patients are required to return to the hospital for the third measurement of 24-hour IOP and BP three days after withdrawal of the investigational product. ;Exclusion criteria: 1. Design of time points for IOP and blood pressure monitoring 1.1 Baseline monitoring All of the patients who are using topical drugs for control of pressure inside the eye before initiation of the trial are required to complete a 4-week drug washout period, regardless of the type of IOP-lowering drug used. Patients who are not using IOP-lowering drugs may take the first (baseline) measurement of 24-hour IOP and blood pressure (BP). During each measurement, each of the enrolled patients will be assigned a separate bedroom in the hospital to rest for 24 hours; 1.2 Method of drug administration; The patients will be instructed to apply a drop of the drug to each eye once daily at 21:00 when dispensed with the investigational product. The second 24-hour IOP measurement will be performed after 4 weeks of treatment with the investigational product, and the patients will be instructed to withdraw the investigational product after completion of the measurement; 1.3 Third 24-hour measurement; The patients are required to return to the hospital for the third measurement of 24-hour IOP and BP three days after withdrawal of the investigational product. ;Exclusion criteria: 1. Design of time points for IOP and blood pressure monitoring 1.1 Baseline monitoring All of the patients who are using topical drugs for control of pressure inside the eye before initiation of the trial are required to complete a 4-week drug washout period, regardless of the type of IOP-lowering drug used. Patients who are not using IOP-lowering drugs may take the first (baseline) measurement of 24-hour IOP and blood pressure (BP). During each measurement, each of the enrolled patients will be assigned a separate bedroom in the hospital to rest for 24 hours; 1.2 Method of drug administration; The patients will be instructed to apply a drop of the drug to each eye once daily at 21:00 when dispensed with the investigational product. The second 24-hour IOP measurement will be performed after 4 weeks of treatment with the investigational product, and the patients will be instructed to withdraw the investigational product after completion of the measurement; 1.3 Third 24-hour measurement; The patients are required to return to the hospital for the third measurement of 24-hour IOP and BP three days after withdrawal of the investigational product. ;Exclusion criteria: 1. Design of time points for IOP and blood pressure monitoring 1.1 Baseline monitoring All of the patients who are using topical drugs for control of pressure inside the eye before initiation of the trial are required to complete a 4-week drug washout period, regardless of the type of IOP-lowering drug used. Patients who are not using IOP-lowering drugs may take the first (baseline) measurement of 24-hour IOP and blood pressure (BP). During each measurement, each of the enrolled patients will be assigned a separate bedroom in the hospital to rest for 24 hours; 1.2 Method of drug administration; The patients will be instructed to apply a drop of the drug to each eye once daily at 21:00 when dispensed with the investigational product. The second 24-hour IOP measurement will be performed after 4 weeks of treatment with the investigational product, and the patients will be instructed to withdraw the investigational product after completion of the measurement; 1.3 Third 24-hour measurement; The patients are required to return to the hospital for the third measurement of 24-hour IOP and BP three days after withdrawal of the investigational product. ;Exclusion criteria: 1. Design of time points for IOP and blood pressure monitoring 1.1 Baseline monitoring All of the patients who are using topical drugs for control of pressure inside the eye before initiation of the trial are required to complete a 4-week drug washout period, regardless of the type of IOP-lowering drug used. Patients who are not using IOP-lowering drugs may take the first (baseline) measurement of 24-hour IOP and blood pressure (BP). During each measurement, each of the enrolled patients will be assigned a separate bedroom in the hospital to rest for 24 hours; 1.2 Method of drug administration; The patients will be instructed to apply a drop of the drug to each eye once daily at 21:00 when dispensed with the investigational product. The second 24-hour IOP measurement will be performed after 4 weeks of treatment with the investigational product, and the patients will be instructed to withdraw the investigational product after completion of the measurement; 1.3 Third 24-hour measurement; The patients are required to return to the hospital for the third measurement of 24-hour IOP and BP three days after withdrawal of the investigational product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| intraocular pressure; | — |
Secondary
| Measure | Time frame |
|---|---|
| blood pressure; | — |
Countries
China
Contacts
Public ContactYuan Huiping;Yuan Huiping;Yuan Huiping;Yuan Huiping;Yuan Huiping ;;;;
The Second Affiliated Hospital of Harbin Medical University;The Second Affiliated Hospital of Harbin Medical University;The Second Affiliated Hospital of Harbin Medical University;The Second Affiliated Hospital of Harbin Medical University;The Second Affiliated Hospital of Harbin Medical University
Outcome results
None listed