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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 19 February 2015
Main ID:  NCT01601028
Date of registration: 29/04/2012
Prospective Registration: No
Primary sponsor: Seoul National University Hospital
Public title: Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome
Scientific title: Phase 3 Study of Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome
Date of first enrolment: July 2011
Target sample size: 39
Recruitment status: Completed
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  
Phase:  Phase 3
Countries of recruitment
Korea, Republic of
Key inclusion & exclusion 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

Age minimum: 19 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Autoimmune Diseases
Dry Eye
Sjogren's Syndrome
Drug: Hydroxychloroquine
Drug: Placebo
Primary Outcome(s)
Serum cytokine level [Time Frame: 16 weeks]
Secondary Outcome(s)
Changes in serum T-cell property [Time Frame: 16 weeks]
Color test [Time Frame: 16 weeks]
Corneal punctate fluorescein staining score [Time Frame: 16 weeks]
Indicator of inflammation [Time Frame: 16 weeks]
Retinal exam [Time Frame: 16 weeks]
Subjective clinical eye complaints [Time Frame: 16 weeks]
Tear breakup time [Time Frame: 16 weeks]
Tear cytokine level [Time Frame: 16 weeks]
Tear production [Time Frame: 16 weeks]
Visual acuity [Time Frame: 16 weeks]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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