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A multicenter randomized controlled trial on prevention and treatment of ocular surface injury and meibomian gland dysfunction in patients using anti-glaucoma eye drops.
1. To compare the efficacy of drug therapy (sodium hyaluronate + sodium bromide) and combined therapy (combined with meibomian gland massage based on drug therapy) on drug-induced dry eye caused by long-term use of anti glaucoma drugs; 2. To evaluate the efficacy of sodium hyaluronate in the prevention of ocular surface and meibomian gland dysfunction and structural damage in the early stage of patients using anti glaucoma eye drops.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 Medicine treatment group | Experimental | 0.3%sodium hyaluronate ophthalmic solution + 0.1 sodium bromide solution, 28 days |
|
| A2 Combined treatment group | Experimental | 0.3%sodium hyaluronate ophthalmic solution + 0.1 sodium bromide solution,with meibomian gland massage , 28 days |
|
| B1 Control group | Placebo Comparator | Placebo |
|
| B2 Experiment group | Experimental | 0.3%sodium hyaluronate ophthalmic solution, 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.3% sodium hyaluronate ophthalmic solution | Drug | one to two drops in eye, four times per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Ocular Surface Disease Index (OSDI) score | Primary indicator | At screening, 1 month and 2 months for treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Tear break up time (TBUT) | Secondary indicator | At screening, 1 month and 2 months for treatment. |
| Change from baseline in corneal staining scores | Secondary indicator |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure | Additional indicator | At screening, 1 month and 2 months for treatment. |
| Change from baseline in number of blocked meibomian glands | Additional indicator |
Inclusion Criteria:
18-80 years of age, diagnosed with glaucoma, including primary open-angle glaucoma or primary angle closure glaucoma, require treatment with anti-glaucoma eye drops.
A group: Patients using glaucoma eye drops longer than 6 months, and in accordance with the diagnostic criteria of dry eye:
The choice of study eyes: Choose the eye of the patient with low basical intraocular pressure, and if the basal intraocular pressure is the same, choose the right eye for the study.
Voluntary participation in this clinical study, and signed informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yingli Li | Contact | +81-18124783057 | liyingli333@qq.com | |
| Xinhua Xi | Contact | +81-18025388978 | xhxi96@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yingli Li | Shenzhen Hospital of Southern Medicine University | Study Chair |
| Min Fu | Zhejiang Hospital | Principal Investigator |
| Lang Bai |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yingli Li | Shenzhen | Guangdong | 518110 | China |
If we decided to share the individual participants data (IPD), the IPD will be shared with in six months after the clinical trial by loading ResMan(the web-based medical research public management platform- Research manager, ResMan).
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D000080343 | Meibomian Gland Dysfunction |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D005141 | Eyelid Diseases |
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| 0.1% sodium bromide solution | Drug | one to two drops in eye, twice per day |
|
| Meibomian gland massage | Other | Physiotherapy |
|
| Placebo | Other | Vehicle |
|
| At screening, 1 month and 2 months for treatment. |
| Change from baseline in schirmer test | Secondary indicator | At screening, 1 month and 2 months for treatment. |
| At screening, 1 month and 2 months for treatment. |
| Nanfang Hospital, Southern Medical University |
| Principal Investigator |
| Guanghua Zhou | The Fifth Affiliated Hospital of Southern Medical University | Principal Investigator |
| Lei Xi | Guangdong Provincial People's Hospital | Principal Investigator |
| Xiaolin Zhao | Shenzhen Hospital of Southern Medicine University | Principal Investigator |
| Wanli Liu | Shenzhen Hospital of Southern Medicine University | Principal Investigator |
| Yan Wang | Shenzhen Hospital of Southern Medicine University | Principal Investigator |
| Lina Chen | Shenzhen Hospital of Southern Medicine University | Principal Investigator |
| Sijing Zhang | Shenzhen Hospital of Southern Medicine University | Principal Investigator |
| Shingle An | Southern Medicine University | Principal Investigator |
| Liang Zhang | Guangdong Provincial People's Hospital | Principal Investigator |
| Ting Meng | Zhejiang Hospital | Principal Investigator |