Corneal Epitheliotropic Factors in Autologous Serum Eye Drops in Nonautoimmune and Stevens-Johnson Syndrome With Dry Eye

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Brief Title

Corneal Epitheliotropic Factors in Autologous Serum Eye Drops in Nonautoimmune and Stevens-Johnson Syndrome With Dry Eye

Official Title

Comparison of Corneal Epitheliotropic Factors in Autologous Serum Eye Drops Between Nonautoimmune Dry Eye and Stevens-Johnson Syndrome With Dry Eye

Brief Summary

      Autologous serum eye drops (ASE) have been becoming popular in treatment of severe dry eye
      for the past decade. One of the most beneficial properties of the ASE over artificial eye
      drops is the epitheliotropic capacity owing to the presence of growth factors and other
      proteins. There have been reports on alteration of serum growth factors in autoimmune
      diseases such as rheumatoid arthritis. Alteration in serum growth factors may lead to
      different therapeutic effect of ASE. We therefore would like to know if there are any
      alteration growth factors, epidermal growth factor (EGF), transforming growth factor-beta1
      (TGF-β1), transforming growth factor-beta2 (TGF-β2), and fibronectin, in ASE from
      Stevens-Johnson syndrome (SJS) patients with dry eye, which constitutes a major group of ASE
      usage in Siriraj Hospital, as compared with non-autoimmune dry eye. We also study stability
      of these factors following different storage conditions.
    

Detailed Description

      Ten SJS patients with dry eye and 10 non-autoimmune dry eye patients are recruited in this
      study. Twenty to forty mL of peripheral venous blood is drawn and the serum is separated. The
      serum is diluted with Balanced Salt Solution (BSS) to provide 20% ASE. The levels of EFG,
      TGF-β1, TGF-β2, and fibronectin in 20% ASE are quantitated by enzyme-linked immunosorbent
      assay (ELISA) method and are compared between the two groups of samples. To study the
      stability of these serum factors under storage conditions used in clinical settings, 20% ASE
      are stored at different temperature and time i.e., at 4 ํC for 1 week and 1 month, and at -20
      ํC for 1, 3 and 6 month. Their levels are then measured following each storage condition.
    


Study Type

Observational


Primary Outcome

Comparisons of the concentrations of EGF, TGF-β1, TGF-β2 and fibronectin in 20% ASE between SJS patients with dry eye and non-autoimmune dry eye patients

Secondary Outcome

 The concentrations EGF, TGF-β1, TGF-β2 and fibronectin in 20% ASE of SJS patients with dry eye syndrome and of non-autoimmune dry eye patients at different storage conditions i.e., at 4 °C for 1 week and 1 months, and at -20 °C for 1, 3 and 6 months

Condition

Stevens-Johnson Syndrome


Study Arms / Comparison Groups

 SJS
Description:  Stevens-Johnson syndrome patients with dry eye

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

20

Start Date

December 2009

Completion Date

December 2010

Primary Completion Date

June 2010

Eligibility Criteria

        Inclusion Criteria:

        SJS group

          -  Patients diagnosed with SJS with dry eye syndrome

          -  Age more than 18 years old

        Control group

          -  Patients diagnosed with dry eye syndrome

          -  Age more than 18 years old

        Dry eye syndrome is defined as the having at least one symptom and one sign as the
        following:

        Symptoms

          1. Dryness sensation in the eye

          2. Sandiness sensation in the eye

          3. Burning sensation in the eye

          4. Redness of the eye

          5. Eye irritation

          6. Eye stuck shut in the morning

        Signs

          1. Meibomian gland dysfunction

          2. Tear film break-up time (TFBUT) < 10 sec

          3. Fluorescein staining at cornea

          4. Schirmer test without anesthesia score ≤ 5 mm / 5 min

          5. Ocular surface problems

        Exclusion Criteria:

          -  Taking immunosuppressive drugs

          -  Acquired immunodeficiency syndrome (AIDS) patients or other immunodeficiency
             conditions

          -  Having autoimmune disorders (except for SJS in case group)

          -  Having systemic underlying diseases such as uncontrolled diabetes mellitus (DM),
             chronic kidney disease, liver cirrhosis, or systemic infection

          -  Pregnant women
      

Gender

All

Ages

19 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Pinnita Prabhasawat, MD, , 

Location Countries

Thailand

Location Countries

Thailand

Administrative Informations


NCT ID

NCT01122303

Organization ID

520/2552(EC4)



Study Sponsor

Mahidol University


Study Sponsor

Pinnita Prabhasawat, MD, Principal Investigator, Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University


Verification Date

May 2010