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

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ClinicalTrials.gov Identifier: NCT01601028
Recruitment Status : Completed
First Posted : May 17, 2012
Last Update Posted : October 17, 2013
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

April 29, 2012
May 17, 2012
October 17, 2013
July 2011
August 2013   (Final data collection date for primary outcome measure)
Serum cytokine level [ Time Frame: 16 weeks ]
IL-6, IL-17, IL-1b, TNF-alpha, INF-alpha, BAFF, etc.
Same as current
Complete list of historical versions of study NCT01601028 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome
Phase 3 Study of 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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Autoimmune Diseases
  • Sjogren's Syndrome
  • Dry Eye
  • 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)
  • Active Comparator: Hydroxychloroquine
    Hydroxychloroquine 300 mg once daily p.o.
    Intervention: Drug: Hydroxychloroquine
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
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 Sjögren'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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
60
August 2013
August 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
19 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01601028
Hydroxychloroquine
Yes
Not Provided
Not Provided
Seoul National University Hospital
Seoul National University Hospital
Not Provided
Not Provided
Seoul National University Hospital
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP