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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03434106
Date of registration: 09/02/2018
Prospective Registration: Yes
Primary sponsor: LanZhou University
Public title: Sjögren's Syndrome Is Associated With Meibomian Gland Dysfunction
Scientific title: Sjögren's Syndrome Is Associated With Meibomian Gland Dysfunction
Date of first enrolment: February 10, 2018
Target sample size: 60
Recruitment status: Unknown status
URL:  https://clinicaltrials.gov/show/NCT03434106
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:     Jingmin Yuan
Address: 
Telephone: +(86)15002626556
Email: 15002626556@163.com
Affiliation: 
Name:     Jingmin Yuan, MD
Address: 
Telephone: +(86)15002626556
Email: 15002626556@163.com
Affiliation: 
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: 45 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)
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]
Schirmer's test with and without anesthesia [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]
Secondary Outcome(s)
tear meniscus [Time Frame: up to 3 months after tear substitutes apply]
rose bengal staining of the conjunctiva [Time Frame: up to 3 months after tear substitutes apply]
Secondary ID(s)
2018A-005
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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