Comparing the Quality of Topical Autologous Serum in Different Etiologies of Dry Eye Syndrome

• Conditions: Dry Eye Syndrome

• Registration Number: NCT02774707
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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.

Detailed Description

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。

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-10
• Study First Submitted QC: 2016-05-13
• Study First Posted: 2016-05-17
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-06
• Last Update Posted: 2016-12-08
• Primary Completion: 2017-01
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Epidermal growth factor concentration in human autologous serum from different etiologies of dry eye	1 year	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.
Transforming growth factor beta (ng/ml) concentration in human autologous serum from different etiologies of dry eye	1 year	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.
Fibronectin (ug/ml) concentration in human autologous serum from different etiologies of dry eye	1 year	We would measureFibronectin (ug/ml) concentration by ELISA according to the manufactures instruction.; We plan to collect 40 patients from different groups.
Hyaluronic acid (ug/ml) concentration in human autologous serum from different etiologies of dry eye	1 year	We would measure Hyaluronic acid (ug/ml) concentration by ELISA according to the manufactures instruction.; We plan to collect 40 patients from different groups.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan