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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03434106 |
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Date of registration:
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09/02/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Sjögren's Syndrome Is Associated With Meibomian Gland Dysfunction
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Scientific title:
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Sjögren's Syndrome Is Associated With Meibomian Gland Dysfunction |
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Date of first enrolment:
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February 10, 2018 |
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Target sample size:
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60 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT03434106 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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China
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Contacts
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Name:
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Jingmin Yuan |
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Address:
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Telephone:
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+(86)15002626556 |
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Email:
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15002626556@163.com |
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Affiliation:
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Name:
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Jingmin Yuan, MD |
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Address:
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Telephone:
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+(86)15002626556 |
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Email:
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15002626556@163.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Sjögren's Syndrome
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Meibomian Gland Dysfunction
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Intervention(s)
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Drug: liposic
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Drug: Tears Naturale Forte
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Primary Outcome(s)
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noninvasive tear breakup time
[Time Frame: up to 3 months after tear substitutes apply]
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Ocular Surface Disease Index
[Time Frame: up to 3 months after tear substitutes apply]
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Schirmer's test with and without anesthesia
[Time Frame: up to 3 months after tear substitutes apply]
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fluorescein staining of the cornea
[Time Frame: up to 3 months after tear substitutes apply]
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meibomian gland function
[Time Frame: up to 3 months after tear substitutes apply]
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Secondary Outcome(s)
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tear meniscus
[Time Frame: up to 3 months after tear substitutes apply]
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rose bengal staining of the conjunctiva
[Time Frame: up to 3 months after tear substitutes apply]
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Secondary ID(s)
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2018A-005
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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