Clinical trial NCT01122303: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stevens-Johnson Syndrome
Keywords: Autologous serum eye drops
EGF
TGF-β1
TGF-β2
Fibronectin
Stevens-Johnson syndrome
Dry eye
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2010-05-13
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: SJS patients with dry eye and non-autoimmune dry eye patients who are treated at Siriraj Hospital, Bangkok, Thailand

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.

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

Primary outcomes:
measure: 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
timeFrame: 1 year
Secondary outcomes:
measure: 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
timeFrame: 1 year
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University
Study officials:
affiliation: Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University
name: Pinnita Prabhasawat, MD
role: PRINCIPAL_INVESTIGATOR
References: