Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome
This study is currently recruiting participants.
Verified May 2012 by Seoul National University Hospital
Sponsor:
Seoul National University Hospital
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01601028
First received: April 29, 2012
Last updated: May 15, 2012
Last verified: May 2012
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Autoimmune Diseases Sjogren's Syndrome Dry Eye |
Drug: Hydroxychloroquine Drug: Placebo |
Phase 3 |
| 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 |
| Official Title: | Phase 3 Study of Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome |
Resource links provided by NLM:
Further study details as provided by Seoul National University Hospital:
Primary Outcome Measures:
- Serum cytokine level [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]IL-6, IL-17, IL-1b, TNF-alpha, INF-alpha, BAFF, etc.
Secondary Outcome Measures:
- Retinal exam [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]Macular exam for monitoring Hydroxychloroquine macular toxicity
- Indicator of inflammation [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Serum ESR
- Tear production [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Schirmer's test
- Subjective clinical eye complaints [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Ocular Surface Disease Index (OSDI)
- Tear cytokine level [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]IL-6, IL-17, IL-1b, TNF-alpha, INF-alpha, BAFF, etc.
- Visual acuity [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Best corrected visual acuity (Snellen)
- Color test [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]HRR color vision test for monitoring hydroxychloroquine retinal toxicity
- Tear breakup time [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]BUT (sec)
- Corneal punctate fluorescein staining score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Corneal staining score (National Eye Institute Scale)
- Changes in serum T-cell property [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Serum T-cell property (FACS)
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Hydroxychloroquine
Hydroxychloroquine 300 mg once daily p.o.
|
Drug: Hydroxychloroquine
Hydroxychloroquine 300 mg once daily p.o. for 12 weeks and go off medication for 4 weeks (total 16 weeks)
|
|
Placebo Comparator: Placebo
Placebo
|
Drug: Placebo
2cp/day for 12 weeks and go off medication for 4 weeks (total 16 weeks)
|
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01601028
Contacts
| Contact: Mee Kum Kim, MD, PhD | +82-2-2072-2437 | kmk9@snu.ac.kr |
| Contact: Chang-Ho Yoon, MD | +82-2-2072-2437 | y0726@yahoo.co.kr |
Locations
| Korea, Republic of | |
| Seoul National Unversity Hospital | Recruiting |
| Seoul, Korea, Republic of, 110-744 | |
| Contact: Chang-Ho Yoon, MD +82-2-2072-2437 y0726@yahoo.co.kr | |
| Principal Investigator: Mee Kum Kim, MD,PhD | |
Sponsors and Collaborators
Seoul National University Hospital
More Information
No publications provided
| Responsible Party: | Seoul National University Hospital |
| ClinicalTrials.gov Identifier: | NCT01601028 History of Changes |
| Other Study ID Numbers: | Hydroxychloroquine |
| Study First Received: | April 29, 2012 |
| Last Updated: | May 15, 2012 |
| Health Authority: | Korea: Institutional Review Board |
Keywords provided by Seoul National University Hospital:
|
Autoimmune Diseases Sjogren's Syndrome Hydroxychloroquine |
Additional relevant MeSH terms:
|
Salivary Gland Diseases Autoimmune Diseases Keratoconjunctivitis Sicca Dry Eye Syndromes Sjogren's Syndrome Immune System Diseases Keratoconjunctivitis Conjunctivitis Conjunctival Diseases Eye Diseases Keratitis Corneal Diseases Lacrimal Apparatus Diseases Arthritis, Rheumatoid Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Xerostomia Mouth Diseases Stomatognathic Diseases Connective Tissue Diseases Hydroxychloroquine Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antimalarials Antiprotozoal Agents |
ClinicalTrials.gov processed this record on June 18, 2013