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NCT Number: NCT01601028

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

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).

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Key information

Conditions

Autoimmune Diseases Arthritis Arthritis, Rheumatoid Connective Tissue Diseases Dry Eye Dry Eye Syndromes Eye Diseases Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Mouth Diseases Musculoskeletal Diseases Rheumatic Diseases Salivary Gland Diseases Sjogren's Syndrome Skin and Connective Tissue Diseases Stomatognathic Diseases Xerostomia

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National Unversity Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydroxychloroquine

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Serum cytokine level

    Time frame: 16 weeks

    IL-6, IL-17, IL-1b, TNF-alpha, INF-alpha, BAFF, etc.

Secondary outcomes

  1. Retinal exam

    Time frame: 16 weeks

    Macular exam for monitoring Hydroxychloroquine macular toxicity

  2. Indicator of inflammation

    Time frame: 16 weeks

    Serum ESR

  3. Tear production

    Time frame: 16 weeks

    Schirmer's test

  4. Subjective clinical eye complaints

    Time frame: 16 weeks

    Ocular Surface Disease Index (OSDI)

  5. Tear cytokine level

    Time frame: 16 weeks

    IL-6, IL-17, IL-1b, TNF-alpha, INF-alpha, BAFF, etc.

  6. Visual acuity

    Time frame: 16 weeks

    Best corrected visual acuity (Snellen)

  7. Color test

    Time frame: 16 weeks

    HRR color vision test for monitoring hydroxychloroquine retinal toxicity

  8. Tear breakup time

    Time frame: 16 weeks

    BUT (sec)

  9. Corneal punctate fluorescein staining score

    Time frame: 16 weeks

    Corneal staining score (National Eye Institute Scale)

  10. Changes in serum T-cell property

    Time frame: 16 weeks

    Serum T-cell property (FACS)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Phase 3 Study of Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 17, 2012
Registry last updated
Oct 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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