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

Phase 3

Completed

• Conditions: Dry Eye; Sjogren's Syndrome; Autoimmune Diseases
• Interventions: Drug: Hydroxychloroquine; Drug: Placebo

• Registration Number: NCT01601028
• Lead Sponsor: Seoul National University Hospital

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2012-04-29
• Study First Submitted QC: 2012-05-15
• Study First Posted: 2012-05-17
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-16
• Last Update Posted: 2013-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydroxychloroquine	Hydroxychloroquine	Hydroxychloroquine 300 mg once daily p.o.
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Serum cytokine level	16 weeks	IL-6, IL-17, IL-1b, TNF-alpha, INF-alpha, BAFF, etc.

Secondary Outcome Measures

Name	Time	Method
Tear cytokine level	16 weeks	IL-6, IL-17, IL-1b, TNF-alpha, INF-alpha, BAFF, etc.
Retinal exam	16 weeks	Macular exam for monitoring Hydroxychloroquine macular toxicity
Indicator of inflammation	16 weeks	Serum ESR
Tear production	16 weeks	Schirmer's test
Subjective clinical eye complaints	16 weeks	Ocular Surface Disease Index (OSDI)
Visual acuity	16 weeks	Best corrected visual acuity (Snellen)
Tear breakup time	16 weeks	BUT (sec)
Corneal punctate fluorescein staining score	16 weeks	Corneal staining score (National Eye Institute Scale)
Changes in serum T-cell property	16 weeks	Serum T-cell property (FACS)
Color test	16 weeks	HRR color vision test for monitoring hydroxychloroquine retinal toxicity

Trial Locations

Locations (1)

Seoul National Unversity Hospital; 🇰🇷 Seoul, Korea, Republic of