NCT01601028

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Autoimmune Diseases
• Sjogren's Syndrome
• Dry Eye

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2012-05-17
• Last updated: 2013-10-17

Locations

1 site across 1 country: South Korea