An observational study in Dry Eye Syndrome, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-08.
Sponsored by National Taiwan University Hospital · Observational
Human autologous serum is commonly used in the treatment of dry eye disease. However, different patients may have different effect with autologous serum treatment. We would like to find if different autologous serum had different component of cytokines in different etiologies of dry eye.
Dry eye is an important issue in the filed of ophthalmology and has great influence on the quality of life in many patients. Traditional treatment was mainly focused on artificial tear supplement. Inflammatory factors are identified in the recent days and are thought to play an important role in the etiology of dry eye. Anti-inflammatory agent like topical immunosuppressant has become another choice in the treatment of dry eye.
Conventional artificial tear has similar biochemical features and osmolarity with natural tear but lacks the anti-inflammatory cytokines. Therefore, autologous serum has been applied as a substitute of natural tear because it has more anti-inflammatory cytokines. Clinical trials have shown that autologous serum drops improve ocular irritation symptoms, and conjunctival and corneal dye staining in dry eye.
However, in the manufacture of autologous serum, it is hard to standardize every step and control quality. What's more, the patient may have different etiology of dry eye, including primary Sjogren's syndrome, secondary Sjogren's syndrome, other autoimmune disease, or ocular graft versus host disease. The etiology of dry eye may have different response to autologous serum. However, we don't know if the autologous serum from different patients' have different components and the different components of cytokines may have different treatment efficacy. This is what we want to know in this study.
Since human autologous serum is needed for cytokine analysis, we proposed this project to collect human serum from volunteers。
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's planned enrollment of 100 is above the median of 90 across 171 observational studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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Exclusion criteria
Epidermal growth factor concentration in human autologous serum from different etiologies of dry eye
We would measure Epidermal growth factor concentration (ng/ml) by ELISA according to the manufactures instruction. We plan to collect 40 patients from different groups.
Time frame: 1 year
Transforming growth factor beta (ng/ml) concentration in human autologous serum from different etiologies of dry eye
We would measure Transforming growth factor beta (ng/ml) by ELISA according to the manufactures instruction. We plan to collect 40 patients from different groups.
Time frame: 1 year
Fibronectin (ug/ml) concentration in human autologous serum from different etiologies of dry eye
We would measureFibronectin (ug/ml) concentration by ELISA according to the manufactures instruction. We plan to collect 40 patients from different groups.
Time frame: 1 year
Hyaluronic acid (ug/ml) concentration in human autologous serum from different etiologies of dry eye
We would measure Hyaluronic acid (ug/ml) concentration by ELISA according to the manufactures instruction. We plan to collect 40 patients from different groups.
Time frame: 1 year
Plan to share: Undecided
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This study is status unknown, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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National Taiwan University Hospital