Is Sjögren's Syndrome Associated With Meibomian Gland Dysfunction ?

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03060005
• Date of registration: 23/01/2017
• Prospective Registration: Yes
• Primary sponsor: Tung Wah Hospital
• Public title: Is Sjögren's Syndrome Associated With Meibomian Gland Dysfunction ?
• Scientific title: Is Sjögren's Syndrome Associated With Meibomian Gland Dysfunction ?
• Date of first enrolment: May 1, 2017
• Target sample size: 80
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03060005
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

China

Contacts

• Name: Shaolin Du, MD,PhD
• Affiliation: Tungwah Hospital of Sun Yat-sen University

• Name: Chi Zhang, MD,PhD

• Name: Chi Zhang, MD,PhD

Key inclusion & exclusion criteria

Inclusion Criteria:

- All the subjects are female and age between 50-60 years

- Patients with primary SS fulfilled the criteria established by the European Study
Group

- Patients with SLE and RA met the criteria set by the American College of Rheumatology

Exclusion Criteria:

- The control history of autoimmune disease



Age minimum: 50 Years
Age maximum: 60 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Meibomian Gland Dysfunction

Sjögren's Syndrome

Intervention(s)

Drug: Tears Naturale Forte

Drug: liposic

Primary Outcome(s)

Schirmer's test with and without anesthesia [Time Frame: up to 3 months after tear substitutes apply]

fluorescein staining of the cornea [Time Frame: up to 3 months after tear substitutes apply]

meibomian gland function [Time Frame: up to 3 months after tear substitutes apply]

Ocular Surface Disease Index [Time Frame: up to 3 months after tear substitutes apply]

noninvasive tear breakup time [Time Frame: up to 3 months after tear substitutes apply]

tear meniscus [Time Frame: up to 3 months after tear substitutes apply]

Secondary Outcome(s)

rose bengal staining of the conjunctiva [Time Frame: up to 3 months after tear substitutes apply]

Secondary ID(s)

2017DHLL001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors