Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2025-12-24 @ 7:21 PM
NCT ID:
NCT01122303
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT01122303
Study Brief:
Protocol Section:
NCT01122303