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

Seoul National University

Status and phase: Completed; Phase 3

Conditions: Sjogren's Syndrome; Dry Eye; Autoimmune Diseases

Treatments: Drug: Placebo; Drug: Hydroxychloroquine

Study type: Interventional

Funder types: Other

Identifiers

NCT01601028

Hydroxychloroquine

Details and patient eligibility

About

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).

Enrollment: 39 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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39 participants in 2 patient groups, including a placebo group

Hydroxychloroquine

Active Comparator group

Description:

Hydroxychloroquine 300 mg once daily p.o.

Treatment:

Drug: Hydroxychloroquine

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo