Corneal Epitheliotropic Factors in Autologous Serum Eye Drops in Nonautoimmune and Stevens-Johnson Syndrome With Dry Eye
Recruitment status was Active, not recruiting
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Purpose
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 |
|---|
|
Stevens-Johnson Syndrome |
| Study Type: | Observational |
| Study Design: | 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 |
- 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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- 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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Serum
| Enrollment: | 20 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
SJS
Stevens-Johnson syndrome patients with dry eye
|
|
Control
Non-autoimmune dry eye patients
|
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| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
SJS patients with dry eye and non-autoimmune dry eye patients who are treated at Siriraj Hospital, Bangkok, Thailand
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
Contacts and Locations| Thailand | |
| Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University | |
| Bangkok, Thailand, 10700 | |
| Principal Investigator: | Pinnita Prabhasawat, MD | Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University |
More Information
No publications provided
| Responsible Party: | Pinnita Prabhasawat, Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University |
| ClinicalTrials.gov Identifier: | NCT01122303 History of Changes |
| Other Study ID Numbers: | 520/2552(EC4) |
| Study First Received: | May 1, 2010 |
| Last Updated: | May 11, 2010 |
| Health Authority: | Thailand: Ethical Committee |
Keywords provided by Mahidol University:
|
Autologous serum eye drops EGF TGF-β1 TGF-β2 |
Fibronectin Stevens-Johnson syndrome Dry eye |
Additional relevant MeSH terms:
|
Keratoconjunctivitis Sicca Dry Eye Syndromes Stevens-Johnson Syndrome Keratoconjunctivitis Conjunctivitis Conjunctival Diseases Eye Diseases Keratitis Corneal Diseases Lacrimal Apparatus Diseases Stomatitis Mouth Diseases Stomatognathic Diseases Erythema Multiforme |
Erythema Skin Diseases Skin Diseases, Vesiculobullous Tetrahydrozoline Nasal Decongestants Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Respiratory System Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013