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

Sponsor

Mahidol University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01122303

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stevens-Johnson Syndrome

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 Design

Study Type:

Observational

Actual Enrollment :

20 participants

Time Perspective:

Cross-Sectional

Official Title:

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

Study Start Date :

Dec 1, 2009

Anticipated Primary Completion Date :

Jun 1, 2010

Anticipated Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
SJS Stevens-Johnson syndrome patients with dry eye
Control Non-autoimmune dry eye patients

Outcome Measures

Primary Outcome Measures

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 [1 year]

Secondary Outcome Measures

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 [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Dryness sensation in the eye
Sandiness sensation in the eye
Burning sensation in the eye
Redness of the eye
Eye irritation
Eye stuck shut in the morning

Signs

Meibomian gland dysfunction
Tear film break-up time (TFBUT) < 10 sec
Fluorescein staining at cornea
Schirmer test without anesthesia score ≤ 5 mm / 5 min
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