Autoimmune DiseasesPhase 3NCT01601028
Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome
A Phase 3 study testing Hydroxychloroquine in people with Autoimmune Diseases and Sjogren's Syndrome, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Autoimmune Diseases, Sjogren's Syndrome, Dry Eye
- What is being tested?
- Hydroxychloroquine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2011to Aug 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 3 Study of Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome
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
- Being tested
- Hydroxychloroquine, Placebo
- Keywords
- Autoimmune Diseases, Sjogren's Syndrome, Hydroxychloroquine
- Medical subject headings
- Autoimmune Diseases, Sjogren's Syndrome, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine 300 mg once daily p.o. for 12 weeks and go off medication for 4 weeks (total 16 weeks)
PlaceboDrug
2cp/day for 12 weeks and go off medication for 4 weeks (total 16 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine | Active comparator | Hydroxychloroquine 300 mg once daily p.o. Receives: Drug: Hydroxychloroquine |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum cytokine level
IL-6, IL-17, IL-1b, TNF-alpha, INF-alpha, BAFF, etc.
Measured: 16 weeks
Secondary outcomes (10)
Retinal exam
Macular exam for monitoring Hydroxychloroquine macular toxicity
Measured: 16 weeks
Indicator of inflammation
Serum ESR
Measured: 16 weeks
Tear production
Schirmer's test
Measured: 16 weeks
Subjective clinical eye complaints
Ocular Surface Disease Index (OSDI)
Measured: 16 weeks
Tear cytokine level
IL-6, IL-17, IL-1b, TNF-alpha, INF-alpha, BAFF, etc.
Measured: 16 weeks
Visual acuity
Best corrected visual acuity (Snellen)
Measured: 16 weeks
Color test
HRR color vision test for monitoring hydroxychloroquine retinal toxicity
Measured: 16 weeks
Tear breakup time
BUT (sec)
Measured: 16 weeks
Corneal punctate fluorescein staining score
Corneal staining score (National Eye Institute Scale)
Measured: 16 weeks
Changes in serum T-cell property
Serum T-cell property (FACS)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startJul 2011
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601028
- Sponsor's protocol ID
- Hydroxychloroquine
- Status last verified
- Oct 2013
- First submitted
- 29 Apr 2012
- Last updated
- 17 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yoon CH, Lee HJ, Lee EY, Lee EB, Lee WW, Kim MK, Wee WR. Effect of Hydroxychloroquine Treatment on Dry Eyes in Subjects with Primary Sjogren's Syndrome: a Double-Blind Randomized Control Study. J Korean Med Sci. 2016 Jul;31(7):1127-35. doi: 10.3346/jkms.2016.31.7.1127. Epub 2016 Apr 20.
PubMed 27366013
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome
- ClinicalTrials.gov ID
- NCT01601028
- Acronym / sponsor ID
- Hydroxychloroquine
- Conditions
- Autoimmune Diseases, Sjogren's Syndrome, Dry Eye
- Keywords
- Autoimmune Diseases, Sjogren's Syndrome, Hydroxychloroquine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 17 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine | Active comparator | Drug: HydroxychloroquineHydroxychloroquine 300 mg once daily p.o. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydroxychloroquineHydroxychloroquine 300 mg once daily p.o. for 12 weeks and go off medication for 4 weeks (total 16 weeks) | Drug | Hydroxychloroquine |
| Placebo2cp/day for 12 weeks and go off medication for 4 weeks (total 16 weeks) | Drug | Placebo |
Primary outcome
Serum cytokine level
Time frame: 16 weeks
IL-6, IL-17, IL-1b, TNF-alpha, INF-alpha, BAFF, etc.
10 secondary outcomes
Retinal exam
Time frame: 16 weeks
Indicator of inflammation
Time frame: 16 weeks
Tear production
Time frame: 16 weeks
Subjective clinical eye complaints
Time frame: 16 weeks
Tear cytokine level
Time frame: 16 weeks
Visual acuity
Time frame: 16 weeks
Color test
Time frame: 16 weeks
Tear breakup time
Time frame: 16 weeks
Corneal punctate fluorescein staining score
Time frame: 16 weeks
Changes in serum T-cell property
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2013.
- Derived from this study: PubMed 27366013Yoon CH, Lee HJ, Lee EY, Lee EB, Lee WW, Kim MK, Wee WR. Effect of Hydroxychloroquine Treatment on Dry Eyes in Subjects with Primary Sjogren's Syndrome: a Double-Blind Randomized Control Study. J Korean Med Sci. 2016 Jul;31(7):1127-35. doi: 10.3346/jkms.2016.31.7.1127. Epub 2016 Apr 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydroxychloroquine in people with Autoimmune Diseases and Sjogren's Syndrome, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum cytokine level (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01601028, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2013.