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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01601028
First received: April 29, 2012
Last updated: October 16, 2013
Last verified: October 2013
  Purpose

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).


Condition Intervention Phase
Autoimmune Diseases
Sjogren's Syndrome
Dry Eye
Drug: Hydroxychloroquine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Serum cytokine level [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    IL-6, IL-17, IL-1b, TNF-alpha, INF-alpha, BAFF, etc.


Secondary Outcome Measures:
  • Retinal exam [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    Macular exam for monitoring Hydroxychloroquine macular toxicity

  • Indicator of inflammation [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Serum ESR

  • Tear production [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Schirmer's test

  • Subjective clinical eye complaints [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Ocular Surface Disease Index (OSDI)

  • Tear cytokine level [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    IL-6, IL-17, IL-1b, TNF-alpha, INF-alpha, BAFF, etc.

  • Visual acuity [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Best corrected visual acuity (Snellen)

  • Color test [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    HRR color vision test for monitoring hydroxychloroquine retinal toxicity

  • Tear breakup time [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    BUT (sec)

  • Corneal punctate fluorescein staining score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Corneal staining score (National Eye Institute Scale)

  • Changes in serum T-cell property [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Serum T-cell property (FACS)


Enrollment: 39
Study Start Date: July 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hydroxychloroquine
Hydroxychloroquine 300 mg once daily p.o.
Drug: Hydroxychloroquine
Hydroxychloroquine 300 mg once daily p.o. for 12 weeks and go off medication for 4 weeks (total 16 weeks)
Placebo Comparator: Placebo
Placebo
Drug: Placebo
2cp/day for 12 weeks and go off medication for 4 weeks (total 16 weeks)

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01601028

Locations
Korea, Republic of
Seoul National Unversity Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01601028     History of Changes
Other Study ID Numbers: Hydroxychloroquine
Study First Received: April 29, 2012
Last Updated: October 16, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Autoimmune Diseases
Sjogren's Syndrome
Hydroxychloroquine

Additional relevant MeSH terms:
Autoimmune Diseases
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Sjogren's Syndrome
Syndrome
Arthritis
Arthritis, Rheumatoid
Conjunctival Diseases
Conjunctivitis
Connective Tissue Diseases
Corneal Diseases
Disease
Eye Diseases
Immune System Diseases
Joint Diseases
Keratitis
Keratoconjunctivitis
Lacrimal Apparatus Diseases
Mouth Diseases
Musculoskeletal Diseases
Pathologic Processes
Rheumatic Diseases
Salivary Gland Diseases
Stomatognathic Diseases
Xerostomia
Hydroxychloroquine
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents

ClinicalTrials.gov processed this record on October 23, 2014