Clinical trial NCT02774707: Comparing the Quality of Topical Autologous Serum in Different Etiologies of Dry Eye Syndrome
Official title: Comparing the Quality of Topical Autologous Serum in Different Etiologies of Dry Eye Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dry Eye Syndrome
Keywords: Dry eye
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2016-05-17
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Patients who need autologous human serum as treatment of dry eye disease
2. Healthy volunteers

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。

Eligibility criteria: 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.

Primary outcomes:
measure: Epidermal growth factor concentration in human autologous serum from different etiologies of dry eye
timeFrame: 1 year
measure: Transforming growth factor beta (ng/ml) concentration in human autologous serum from different etiologies of dry eye
timeFrame: 1 year
measure: Fibronectin (ug/ml) concentration in human autologous serum from different etiologies of dry eye
timeFrame: 1 year
measure: Hyaluronic acid (ug/ml) concentration in human autologous serum from different etiologies of dry eye
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: ational Taiwan University Hospital, Ophthalmology Department
name: Wei-Li Chen
role: PRINCIPAL_INVESTIGATOR
References: