Clinical trial NCT01601028: Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome
Official title: Phase 3 Study of Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Autoimmune Diseases
Sjogren's Syndrome
Dry Eye
Keywords: Autoimmune Diseases
Sjogren's Syndrome
Hydroxychloroquine
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-05-17
Enrollment: 39
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Serum cytokine level
timeFrame: 16 weeks
Secondary outcomes:
measure: Retinal exam
timeFrame: 16 weeks
measure: Indicator of inflammation
timeFrame: 16 weeks
measure: Tear production
timeFrame: 16 weeks
measure: Subjective clinical eye complaints
timeFrame: 16 weeks
measure: Tear cytokine level
timeFrame: 16 weeks
measure: Visual acuity
timeFrame: 16 weeks
measure: Color test
timeFrame: 16 weeks
measure: Tear breakup time
timeFrame: 16 weeks
measure: Corneal punctate fluorescein staining score
timeFrame: 16 weeks
measure: Changes in serum T-cell property
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National Unversity Hospital
Study officials:
References:
citation: Yoon CH, Lee HJ, Lee EY, Lee EB, Lee WW, Kim MK, Wee WR. Effect of Hydroxychloroquine Treatment on Dry Eyes in Subjects with Primary Sjogren's Syndrome: a Double-Blind Randomized Control Study. J Korean Med Sci. 2016 Jul;31(7):1127-35. doi: 10.3346/jkms.2016.31.7.1127. Epub 2016 Apr 20.