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Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome

NCT ID: NCT01601028

Last Updated: 2013-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-08-31

Brief Summary

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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).

Detailed Description

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Conditions

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Autoimmune Diseases Sjogren's Syndrome Dry Eye

Keywords

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Autoimmune Diseases Sjogren's Syndrome Hydroxychloroquine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Hydroxychloroquine

Hydroxychloroquine 300 mg once daily p.o.

Group Type ACTIVE_COMPARATOR

Hydroxychloroquine

Intervention Type DRUG

Hydroxychloroquine 300 mg once daily p.o. for 12 weeks and go off medication for 4 weeks (total 16 weeks)

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

2cp/day for 12 weeks and go off medication for 4 weeks (total 16 weeks)

Interventions

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Hydroxychloroquine

Hydroxychloroquine 300 mg once daily p.o. for 12 weeks and go off medication for 4 weeks (total 16 weeks)

Intervention Type DRUG

Placebo

2cp/day for 12 weeks and go off medication for 4 weeks (total 16 weeks)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National Unversity Hospital

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 27366013 (View on PubMed)

Other Identifiers

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Hydroxychloroquine

Identifier Type: -

Identifier Source: org_study_id