- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03434106
Sjögren's Syndrome Is Associated With Meibomian Gland Dysfunction
February 9, 2018 updated by: Jingmin Yuan, MD, LanZhou University
The investigators hypothesize that the dry eye caused by SS may include the evaporative type, resulting from the MGD.
Furthermore, the investigators hypothesize that both pSS and sSS are associated with MGD.To test our hypothesis, we conducted a prospective clinical study in patients with SS (both pSS and sSS) and MGD, and the normal population All subjects were matched for both age and gender and assessed for tear function and ocular surface signs and symptoms.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jingmin Yuan, MD
- Phone Number: +(86)15002626556
- Email: 15002626556@163.com
Study Locations
-
-
Gansu
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Lanzhou, Gansu, China
- Recruiting
- Lanzhou university second hospital
-
Contact:
- Jingmin Yuan
- Phone Number: +(86)15002626556
- Email: 15002626556@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: primary Sjögren's syndrome
The female patients with primary Sjögren's syndrome receive the Tears Naturale Forte and Liposic.
|
Liposic eye gel contain the active ingredient carbomer, which is a type of medicine known as an eye lubricant.
It is used for the treatmen
Other Names:
This medication is used to relieve dry, irritated eyes
Other Names:
|
Experimental: secondary Sjögren's syndrome
The female patients with secondary Sjögren's syndrome receive Tears Naturale Forte and Liposic.
|
Liposic eye gel contain the active ingredient carbomer, which is a type of medicine known as an eye lubricant.
It is used for the treatmen
Other Names:
This medication is used to relieve dry, irritated eyes
Other Names:
|
Experimental: meibomian gland dysfunction
The female patients with meibomian gland dysfunction receive the Tears Naturale Forte and Liposic.
|
Liposic eye gel contain the active ingredient carbomer, which is a type of medicine known as an eye lubricant.
It is used for the treatmen
Other Names:
This medication is used to relieve dry, irritated eyes
Other Names:
|
Experimental: control
the female had no history of autoimmune disease receive the Tears Naturale Forte and Liposic.
|
Liposic eye gel contain the active ingredient carbomer, which is a type of medicine known as an eye lubricant.
It is used for the treatmen
Other Names:
This medication is used to relieve dry, irritated eyes
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ocular Surface Disease Index
Time Frame: up to 3 months after tear substitutes apply
|
The OSDI questionnaire is used to quantify the dry eye symptoms.
Subjects will be asked questions regarding the dry eye symptoms that they had experienced; the OSDI questions is drawn from 3 different subscales: ocular symptoms, vision-related functions, and environmental triggers.
Each answer is scored on a 4-point scale from zero (indicating no problems) to four (indicating a significant problem).
Responses to all of the questions are combined to generate a composite OSDI score that ranges from 0 to 100, with higher OSDI scores indicating more severe symptoms.
Symptoms of dry eye, such as dryness, burning, foreign body sensation, stabbing pain, photophobia, and visual fluctuations, are also noted
|
up to 3 months after tear substitutes apply
|
meibomian gland function
Time Frame: up to 3 months after tear substitutes apply
|
assessment of the quality of meibomian gland secretions, according to a published classification system (21).
In brief, the grading scheme was "0" for clear excreta with small particles, "1" for opaque excreta with normal viscosity, "2" for opaque excreta with increased viscosity, and "3" for secreta that retained shape after digital expression.
|
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
|
Upper, lower, nasal, temporal and central quadrants were used.
Superficial punctate keratopathy (SPK) in the cornea was scored from 0 to 3 in each quadrant: 0, no staining in the cornea; 1, <5 punctuate stains; 2, >5 punctuate stains but <10; and 3, >10 or filamentous staining detected.
The total number was obtained by adding the scores of the four quadrants for each eye (0-15).
|
up to 3 months after tear substitutes apply
|
noninvasive tear breakup time
Time Frame: up to 3 months after tear substitutes apply
|
Four IR diodes were set on the Keratograph 5 (Oculus, Wetzlar, Germany) and arranged in two pairs, located one above the other.
The red ring illumination used for corneal topography was deactivated; this ensured a dark background for the examination.
An illuminated ring pattern was then projected onto the cornea.
At the start of the recording, the subject will be asked to blink his or her eyes three times and then to keep them open as long as possible.
Irregularities in the reflected image will be observed closely.
Special attention will be given to distortions and gaps in individual rings and the time such deviations from the original ring pattern took to occur.
The examination will be recorded on video.
|
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
|
The Schirmer test without anesthesia (S1T) for tear secretion function will be performed by inserting a 30-mm Schirmer tear test strip (Jingming, Tianjing, China) into the inferior fornix at the junction of the middle and lateral thirds of the lower eyelid margin.
Schirmer test strips will remain in place for 5 minutes with the eyes closed.
The extent of wetting will be subsequently measured according to the scale provided by the manufacturer.
Potential scores ranged from 0 to 30 mm, with lower scores indicating greater tear production abnormalities.
|
up to 3 months after tear substitutes apply
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
tear meniscus
Time Frame: up to 3 months after tear substitutes apply
|
The subject will be asked to blink her eyes once ,then the image of tear meniscus height will be captured by a Keratograph 5 (Oculus, Wetzlar, Germany).After that tear meniscus height will be measured at the centre of the lower lid margin.
This performance will be taken three times and the average value will be recorded.
|
up to 3 months after tear substitutes apply
|
rose bengal staining of the conjunctiva
Time Frame: up to 3 months after tear substitutes apply
|
rose bengal staining (graded on a 0-3 scale) of the conjunctiva (six nasal and temporal areas) and the whole cornea.
|
up to 3 months after tear substitutes apply
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 10, 2018
Primary Completion (Anticipated)
May 31, 2018
Study Completion (Anticipated)
June 30, 2018
Study Registration Dates
First Submitted
February 9, 2018
First Submitted That Met QC Criteria
February 9, 2018
First Posted (Actual)
February 15, 2018
Study Record Updates
Last Update Posted (Actual)
February 15, 2018
Last Update Submitted That Met QC Criteria
February 9, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Autoimmune Diseases
- Eye Diseases
- Disease
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Stomatognathic Diseases
- Mouth Diseases
- Lacrimal Apparatus Diseases
- Arthritis, Rheumatoid
- Xerostomia
- Salivary Gland Diseases
- Dry Eye Syndromes
- Eyelid Diseases
- Syndrome
- Sjogren's Syndrome
- Meibomian Gland Dysfunction
- Anticoagulants
- Plasma Substitutes
- Blood Substitutes
- Dextrans
Other Study ID Numbers
- 2018A-005
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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