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

Overview

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).

Full Title of Study: “Phase 3 Study of Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren’s Syndrome”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2013

Interventions

  • Drug: Hydroxychloroquine
    • Hydroxychloroquine 300 mg once daily p.o. for 12 weeks and go off medication for 4 weeks (total 16 weeks)
  • Drug: Placebo
    • 2cp/day for 12 weeks and go off medication for 4 weeks (total 16 weeks)

Arms, Groups and Cohorts

  • Active Comparator: Hydroxychloroquine
    • Hydroxychloroquine 300 mg once daily p.o.
  • Placebo Comparator: Placebo
    • Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Serum cytokine level
    • Time Frame: 16 weeks
    • IL-6, IL-17, IL-1b, TNF-alpha, INF-alpha, BAFF, etc.

Secondary Measures

  • Retinal exam
    • Time Frame: 16 weeks
    • Macular exam for monitoring Hydroxychloroquine macular toxicity
  • Indicator of inflammation
    • Time Frame: 16 weeks
    • Serum ESR
  • Tear production
    • Time Frame: 16 weeks
    • Schirmer’s test
  • Subjective clinical eye complaints
    • Time Frame: 16 weeks
    • Ocular Surface Disease Index (OSDI)
  • Tear cytokine level
    • Time Frame: 16 weeks
    • IL-6, IL-17, IL-1b, TNF-alpha, INF-alpha, BAFF, etc.
  • Visual acuity
    • Time Frame: 16 weeks
    • Best corrected visual acuity (Snellen)
  • Color test
    • Time Frame: 16 weeks
    • HRR color vision test for monitoring hydroxychloroquine retinal toxicity
  • Tear breakup time
    • Time Frame: 16 weeks
    • BUT (sec)
  • Corneal punctate fluorescein staining score
    • Time Frame: 16 weeks
    • Corneal staining score (National Eye Institute Scale)
  • Changes in serum T-cell property
    • Time Frame: 16 weeks
    • Serum T-cell property (FACS)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor

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