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

Primary Purpose

Autoimmune Diseases, Sjogren's Syndrome, Dry Eye

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Hydroxychloroquine
Placebo
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autoimmune Diseases focused on measuring Autoimmune Diseases, Sjogren's Syndrome, Hydroxychloroquine

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National Unversity Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Hydroxychloroquine

Placebo

Arm Description

Hydroxychloroquine 300 mg once daily p.o.

Placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 29, 2012
Last Updated
October 16, 2013
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01601028
Brief Title
Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome
Official Title
Phase 3 Study of Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Diseases, Sjogren's Syndrome, Dry Eye
Keywords
Autoimmune Diseases, Sjogren's Syndrome, Hydroxychloroquine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydroxychloroquine
Arm Type
Active Comparator
Arm Description
Hydroxychloroquine 300 mg once daily p.o.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
Hydroxychloroquine 300 mg once daily p.o. for 12 weeks and go off medication for 4 weeks (total 16 weeks)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2cp/day for 12 weeks and go off medication for 4 weeks (total 16 weeks)
Primary Outcome Measure Information:
Title
Serum cytokine level
Description
IL-6, IL-17, IL-1b, TNF-alpha, INF-alpha, BAFF, etc.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Retinal exam
Description
Macular exam for monitoring Hydroxychloroquine macular toxicity
Time Frame
16 weeks
Title
Indicator of inflammation
Description
Serum ESR
Time Frame
16 weeks
Title
Tear production
Description
Schirmer's test
Time Frame
16 weeks
Title
Subjective clinical eye complaints
Description
Ocular Surface Disease Index (OSDI)
Time Frame
16 weeks
Title
Tear cytokine level
Description
IL-6, IL-17, IL-1b, TNF-alpha, INF-alpha, BAFF, etc.
Time Frame
16 weeks
Title
Visual acuity
Description
Best corrected visual acuity (Snellen)
Time Frame
16 weeks
Title
Color test
Description
HRR color vision test for monitoring hydroxychloroquine retinal toxicity
Time Frame
16 weeks
Title
Tear breakup time
Description
BUT (sec)
Time Frame
16 weeks
Title
Corneal punctate fluorescein staining score
Description
Corneal staining score (National Eye Institute Scale)
Time Frame
16 weeks
Title
Changes in serum T-cell property
Description
Serum T-cell property (FACS)
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Seoul National Unversity Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
27366013
Citation
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 Sjogren'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.
Results Reference
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Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome

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