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

Dry Eye Clinical Trial

Official title:

Phase 3 Study of Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01601028
• Other study ID #: Hydroxychloroquine
• Status: Completed
• Phase: Phase 3
• First received: April 29, 2012
• Last updated: October 16, 2013
• Start date: July 2011
• Est. completion date: August 2013

Study information

• Verified date: October 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autoimmune Diseases
• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Sjogren's Syndrome
• Syndrome

Intervention

Drug:
• Hydroxychloroquine
Hydroxychloroquine 300 mg once daily p.o. for 12 weeks and go off medication for 4 weeks (total 16 weeks)
• Placebo
2cp/day for 12 weeks and go off medication for 4 weeks (total 16 weeks)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National Unversity Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum cytokine level	IL-6, IL-17, IL-1b, TNF-alpha, INF-alpha, BAFF, etc.	16 weeks	No
Secondary	Retinal exam	Macular exam for monitoring Hydroxychloroquine macular toxicity	16 weeks	Yes
Secondary	Indicator of inflammation	Serum ESR	16 weeks	No
Secondary	Tear production	Schirmer's test	16 weeks	No
Secondary	Subjective clinical eye complaints	Ocular Surface Disease Index (OSDI)	16 weeks	No
Secondary	Tear cytokine level	IL-6, IL-17, IL-1b, TNF-alpha, INF-alpha, BAFF, etc.	16 weeks	No
Secondary	Visual acuity	Best corrected visual acuity (Snellen)	16 weeks	No
Secondary	Color test	HRR color vision test for monitoring hydroxychloroquine retinal toxicity	16 weeks	Yes
Secondary	Tear breakup time	BUT (sec)	16 weeks	No
Secondary	Corneal punctate fluorescein staining score	Corneal staining score (National Eye Institute Scale)	16 weeks	No
Secondary	Changes in serum T-cell property	Serum T-cell property (FACS)	16 weeks	No