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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Mahidol University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT01122303
First received: May 1, 2010
Last updated: May 11, 2010
Last verified: May 2010
  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

Resource links provided by NLM:


Further study details as provided by Mahidol University:

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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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 [ 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
Study Population

SJS patients with dry eye and non-autoimmune dry eye patients who are treated at Siriraj Hospital, Bangkok, Thailand

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01122303

Locations
Thailand
Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
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:
Stevens-Johnson Syndrome
Syndrome
Chemically-Induced Disorders
Dermatitis
Disease
Drug Eruptions
Drug Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Erythema
Erythema Multiforme
Hypersensitivity
Immune System Diseases
Mouth Diseases
Pathologic Processes
Skin Diseases
Skin Diseases, Vesiculobullous
Stomatitis
Stomatognathic Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014