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| ID | Type | Description | Link |
|---|---|---|---|
| FML-001 | Other Identifier | SantenChina |
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The purpose of this study is to evaluate the effectiveness of fluorometholone combined with sodium hyaluronate eye drops in the treatment of Sjögren syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | using the 0.1% fluorometholone eye drops combined with the 0.1% sodium hyaluronate eye drops | ||
| Group 2 | using the 0.5% cyclosporin A eye drops combined with 0.1% sodium hyaluronate eye drops |
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| Measure | Description | Time Frame |
|---|---|---|
| tear-film breakup time | stain the cornea with the fluorescein; close the eye; open the eye and keep the eye open,count the seconds until the first black spot appears. | the enrolling day,2 weeks after treatment,4 weeks after treatment,8 weeks after treatment |
| Schirmer test I without anesthesia | put the Schirmer test strip into the lower conjunctival sac; close the eye for 5 minutes; read the score of the test strip | the enrolling day,2 weeks after treatment,4 weeks after treatment, 8 weeks after treatment |
| corneal fluorescein staining | Fluorescein staining scores were measured on 0-3 point scale, in each quarter of corneal zone: 0(No staining), 1(some staining), 2(Staining in more than a half of the area), 3(Staining in the whole area). | the enrolling day,2 weeks after treatment,4 weeks after treatment,8 weeks after treatment |
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Inclusion Criteria:
willing to participate in this clinical study, and signed informed consent
age from 18 to 70 years old,both genders are permitted
diagnosed as the Sjögren syndrome
have the symptoms and signs of dry eye disease as below:
have at least 2 symptoms such as dryness,foreign body sensation ,eye strain,conjunctival congestion,secretion.The summed up score of symptoms greater than 6.
the score of tear-film break up time less than 5 seconds or the score of Schirmer test less than 5mm/5min.
the score of corneal fluorescein staining greater than 3.
Exclusion Criteria:
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the people who suffered from the dry eye disease coused by the Sjögren syndrome
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye & ENT Hospital of Fudan University | Shanghai | 200031 | China |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D012859 | Sjogren's Syndrome |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
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| D007592 |
| Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |