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:
2025-12-26 @ 10:37 AM
Ignite Modification Date:
2025-12-26 @ 10:37 AM
NCT ID:
NCT01601028
Eligibility Criteria:
Inclusion Criteria:
* Patient who is diagnosed with primary Sjögren syndrome according to American/European consensus group (AECG) criteria
* Patient with the ability to give informed, dated and signed consent before the beginning of any proceedings related to the trial
Exclusion Criteria:
* Previous treated by Hydroxychloroquine but enough washout time after discontinuance of treatment, patient can be enrolled. (2 wks)
* Known cardiac disease, Respiratory disease, Renal disease, Gastrointestinal disease (except GERD)
* Diabetes mellitus
* Psoriasis
* Known drug allergy or hypersensitivity
* Previous or ongoing treatment by any drugs (include topical drug) which have effect on lacrimal system. But enough washout time after discontinuance of treatment, patient can be enrolled. (cf. SSRI, Anti-histamine, Pilocarpine, etc.)
* Angle closer glaucoma
* Patient who underwent previous intraocular surgery
* Macular disease
* Previous or ongoing treatment by drug which could have effect on macula
* Pregnancy
* Planning to get pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT01601028
Study Brief:
Protocol Section:
NCT01601028