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

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ClinicalTrials.gov Identifier: NCT02774707
Recruitment Status : Unknown
Verified December 2016 by National Taiwan University Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : May 17, 2016
Last Update Posted : December 8, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Dry Eye Syndrome

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。


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Study Type : Observational
Estimated Enrollment : 100 participants
Time Perspective: Cross-Sectional
Official Title: Comparing the Quality of Topical Autologous Serum in Different Etiologies of Dry Eye Syndrome
Study Start Date : January 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017



Primary Outcome Measures :
  1. Epidermal growth factor concentration in human autologous serum from different etiologies of dry eye [ Time Frame: 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.


  2. Transforming growth factor beta (ng/ml) concentration in human autologous serum from different etiologies of dry eye [ Time Frame: 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.


  3. Fibronectin (ug/ml) concentration in human autologous serum from different etiologies of dry eye [ Time Frame: 1 year ]

    We would measureFibronectin (ug/ml) concentration by ELISA according to the manufactures instruction.

    We plan to collect 40 patients from different groups.


  4. Hyaluronic acid (ug/ml) concentration in human autologous serum from different etiologies of dry eye [ Time Frame: 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.




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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  1. Patients who need autologous human serum as treatment of dry eye disease
  2. Healthy volunteers
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02774707


Locations
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Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Wei-Li Chen ational Taiwan University Hospital, Ophthalmology Department

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02774707     History of Changes
Other Study ID Numbers: 201511091RINB
First Posted: May 17, 2016    Key Record Dates
Last Update Posted: December 8, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by National Taiwan University Hospital:
Dry eye

Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Syndrome
Disease
Pathologic Processes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases