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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01601028
• Date of registration: 29/04/2012
• Prospective Registration: No
• Primary sponsor: Seoul National University Hospital
• Public title: Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome
• Scientific title: Phase 3 Study of Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome
• Date of first enrolment: July 2011
• Target sample size: 39
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01601028
• 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
• Phase: Phase 3

Countries of recruitment

Korea, Republic of

Key inclusion & exclusion 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



Age minimum: 19 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Sjogren's Syndrome

Dry Eye

Autoimmune Diseases

Intervention(s)

Drug: Placebo

Drug: Hydroxychloroquine

Primary Outcome(s)

Serum cytokine level [Time Frame: 16 weeks]

Secondary Outcome(s)

Retinal exam [Time Frame: 16 weeks]

Changes in serum T-cell property [Time Frame: 16 weeks]

Color test [Time Frame: 16 weeks]

Tear cytokine level [Time Frame: 16 weeks]

Visual acuity [Time Frame: 16 weeks]

Corneal punctate fluorescein staining score [Time Frame: 16 weeks]

Subjective clinical eye complaints [Time Frame: 16 weeks]

Tear production [Time Frame: 16 weeks]

Indicator of inflammation [Time Frame: 16 weeks]

Tear breakup time [Time Frame: 16 weeks]

Secondary ID(s)

Hydroxychloroquine

Source(s) of Monetary Support

Please refer to primary and secondary sponsors