Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2025-12-26 @ 12:07 PM
Study NCT ID:
NCT01122303
Status:
UNKNOWN
Last Update Posted:
2010-05-13
First Post:
2010-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Corneal Epitheliotropic Factors in Autologous Serum Eye Drops in Nonautoimmune and Stevens-Johnson Syndrome With Dry Eye
Sponsor:
Mahidol University
Organization:
Study Overview
Official Title:
Comparison of Corneal Epitheliotropic Factors in Autologous Serum Eye Drops Between Nonautoimmune Dry Eye and Stevens-Johnson Syndrome With Dry Eye
Status:
UNKNOWN
Status Verified Date:
2010-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: