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

Dry Eye Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02774707
• Other study ID #: 201511091RINB
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 10, 2016
• Last updated: December 6, 2016
• Start date: January 2016
• Est. completion date: January 2017

Study information

• Verified date: December 2016
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Observational

Clinical Trial 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.

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。

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion criteria

• Healthy volunteer control without ophthalmic history

• Patients with Primary Sjogren's syndrome: according to the classification of American European Consensus Group of rheumatologist and Ophthalmologists,

• Patient with Secondary Sjogren's syndrome: Sjogren's syndrome associated with systemic lupus erythematosus, systemic sclerosis (scleroderma), rheumatoid arthritis, mixed connective tissue disease, inflammatory muscle disease, autoimmune liver disease, and autoimmune thyroid disease

• Ocular graft versus host disease

• Volunteers with dry eye symptoms but not diagnosed with primary Sjogren's syndrome, secondary Sjogren's syndrome and ocular graft versus host disease

Exclusion criteria

• Patients who decline to receive the venipuncture for blood sampling.

• Patients younger than 20 years old or older than 80 years old.

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year	No
Primary	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.	1 year	No
Primary	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.	1 year	No
Primary	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.	1 year	No