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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02774707
Collaborator
(none)
100
Enrollment
1
Location
12
Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated 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 :
    Jan 1, 2016
    Anticipated Primary Completion Date :
    Jan 1, 2017
    Anticipated Study Completion Date :
    Jan 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Hospital Taipei Taiwan

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Principal Investigator: Wei-Li Chen, ational Taiwan University Hospital, Ophthalmology Department

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT02774707
    Other Study ID Numbers:
    • 201511091RINB
    First Posted:
    May 17, 2016
    Last Update Posted:
    Dec 8, 2016
    Last Verified:
    Dec 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by National Taiwan University Hospital
    Dry eye
    Additional relevant MeSH terms:
    Dry Eye Syndromes
    Keratoconjunctivitis Sicca
    Syndrome

    Study Results

    No Results Posted as of Dec 8, 2016