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

NCT01122303 | Unknown

• 1 other identifier: 520/2552(EC4)
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stevens-Johnson Syndrome

Keywords

Autologous serum eye drops; EGF; TGF-β1; TGF-β2; Fibronectin; Stevens-Johnson syndrome; Dry eye

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

SJS

Stevens-Johnson syndrome patients with dry eye

Control

Non-autoimmune dry eye patients

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Bangkok, 10700, Thailand

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Stevens-Johnson Syndrome; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases; Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Erythema Multiforme; Erythema; Skin Diseases, Vesiculobullous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Pinnita Prabhasawat, MD

  Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 1, 2010
• First Posted: May 13, 2010
• Study Start: December 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 13, 2010

Record last verified: 2010-05

Locations

TH (1)