Sjögren's Syndrome Is Associated With Meibomian Gland Dysfunction
Primary Purpose
Meibomian Gland Dysfunction, Sjögren's Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
liposic
Tears Naturale Forte
Sponsored by
About this trial
This is an interventional treatment trial for Meibomian Gland Dysfunction focused on measuring meibomian gland dysfunction, Sjögren's syndrome, dry eye disease
Eligibility 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
Sites / Locations
- Lanzhou University Second HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
primary Sjögren's syndrome
secondary Sjögren's syndrome
meibomian gland dysfunction
control
Arm Description
The female patients with primary Sjögren's syndrome receive the Tears Naturale Forte and Liposic.
The female patients with secondary Sjögren's syndrome receive Tears Naturale Forte and Liposic.
The female patients with meibomian gland dysfunction receive the Tears Naturale Forte and Liposic.
the female had no history of autoimmune disease receive the Tears Naturale Forte and Liposic.
Outcomes
Primary Outcome Measures
Ocular Surface Disease Index
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
meibomian gland function
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.
fluorescein staining of the cornea
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).
noninvasive tear breakup time
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.
Schirmer's test with and without anesthesia
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.
Secondary Outcome Measures
tear meniscus
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.
rose bengal staining of the conjunctiva
rose bengal staining (graded on a 0-3 scale) of the conjunctiva (six nasal and temporal areas) and the whole cornea.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03434106
Brief Title
Sjögren's Syndrome Is Associated With Meibomian Gland Dysfunction
Official Title
Sjögren's Syndrome Is Associated With Meibomian Gland Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 10, 2018 (Actual)
Primary Completion Date
May 31, 2018 (Anticipated)
Study Completion Date
June 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
LanZhou University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction, Sjögren's Syndrome
Keywords
meibomian gland dysfunction, Sjögren's syndrome, dry eye disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
primary Sjögren's syndrome
Arm Type
Experimental
Arm Description
The female patients with primary Sjögren's syndrome receive the Tears Naturale Forte and Liposic.
Arm Title
secondary Sjögren's syndrome
Arm Type
Experimental
Arm Description
The female patients with secondary Sjögren's syndrome receive Tears Naturale Forte and Liposic.
Arm Title
meibomian gland dysfunction
Arm Type
Experimental
Arm Description
The female patients with meibomian gland dysfunction receive the Tears Naturale Forte and Liposic.
Arm Title
control
Arm Type
Experimental
Arm Description
the female had no history of autoimmune disease receive the Tears Naturale Forte and Liposic.
Intervention Type
Drug
Intervention Name(s)
liposic
Other Intervention Name(s)
Carbomer
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Tears Naturale Forte
Other Intervention Name(s)
DEXTRAN/HYPROMELLOSE/GLYCERIN
Intervention Description
This medication is used to relieve dry, irritated eyes
Primary Outcome Measure Information:
Title
Ocular Surface Disease Index
Description
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
Time Frame
up to 3 months after tear substitutes apply
Title
meibomian gland function
Description
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.
Time Frame
up to 3 months after tear substitutes apply
Title
fluorescein staining of the cornea
Description
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).
Time Frame
up to 3 months after tear substitutes apply
Title
noninvasive tear breakup time
Description
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.
Time Frame
up to 3 months after tear substitutes apply
Title
Schirmer's test with and without anesthesia
Description
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.
Time Frame
up to 3 months after tear substitutes apply
Secondary Outcome Measure Information:
Title
tear meniscus
Description
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.
Time Frame
up to 3 months after tear substitutes apply
Title
rose bengal staining of the conjunctiva
Description
rose bengal staining (graded on a 0-3 scale) of the conjunctiva (six nasal and temporal areas) and the whole cornea.
Time Frame
up to 3 months after tear substitutes apply
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jingmin Yuan, MD
Phone
+(86)15002626556
Email
15002626556@163.com
Facility Information:
Facility Name
Lanzhou University Second Hospital
City
Lanzhou
State/Province
Gansu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingmin Yuan
Phone
+(86)15002626556
Email
15002626556@163.com
12. IPD Sharing Statement
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Sjögren's Syndrome Is Associated With Meibomian Gland Dysfunction
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