Autoimmune Diseases, Dry Eye, Sjogren's Syndrome
Conditions
Keywords
Autoimmune Diseases, Sjogren's Syndrome, Hydroxychloroquine
Brief summary
Primary Sjögren syndrome is one of the most prevalent autoimmune diseases that present with dry eye and dry mouth. But there is no proven effective treatment for Sjögren syndrome patient. The relation between toll-like receptor (TLR) and the pathogenesis of Sjögren syndrome has been reported. Hydroxychloroquine is TLR7 and TLR9 antagonist. A few studies have been reported the effectiveness of Hydroxychloroquine for Sjögren syndrome but no randomized controlled study has been done. So the investigators evaluate the effectiveness and safeness of Hydroxychloroquine for primary Sjögren syndrome by randomized controlled study (Hydroxychloroquine 300 mg once daily p.o. group (N = 30) versus placebo group (N = 30).
Interventions
DRUGHydroxychloroquine
Hydroxychloroquine 300 mg once daily p.o. for 12 weeks and go off medication for 4 weeks (total 16 weeks)
DRUGPlacebo
2cp/day for 12 weeks and go off medication for 4 weeks (total 16 weeks)
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum cytokine level | 16 weeks | IL-6, IL-17, IL-1b, TNF-alpha, INF-alpha, BAFF, etc. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Indicator of inflammation | 16 weeks | Serum ESR |
| Tear production | 16 weeks | Schirmer's test |
| Subjective clinical eye complaints | 16 weeks | Ocular Surface Disease Index (OSDI) |
| Tear cytokine level | 16 weeks | IL-6, IL-17, IL-1b, TNF-alpha, INF-alpha, BAFF, etc. |
| Retinal exam | 16 weeks | Macular exam for monitoring Hydroxychloroquine macular toxicity |
| Color test | 16 weeks | HRR color vision test for monitoring hydroxychloroquine retinal toxicity |
| Tear breakup time | 16 weeks | BUT (sec) |
| Corneal punctate fluorescein staining score | 16 weeks | Corneal staining score (National Eye Institute Scale) |
| Changes in serum T-cell property | 16 weeks | Serum T-cell property (FACS) |
| Visual acuity | 16 weeks | Best corrected visual acuity (Snellen) |
Countries
South Korea
Outcome results
None listed