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Is Sjögren's Syndrome Associated With Meibomian Gland Dysfunction ?

Primary Purpose

Sjögren's Syndrome, Meibomian Gland Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tears Naturale Forte
liposic
Sponsored by
Tung Wah Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sjögren's Syndrome focused on measuring Sjögren's syndrome, meibomian gland dysfunction, dry eye disease

Eligibility Criteria

50 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

  • Tungwah Hospital of Sun Yat-sen UniversityRecruiting

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

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
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
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.
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).
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.
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.

Secondary Outcome Measures

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

First Posted
January 23, 2017
Last Updated
May 14, 2017
Sponsor
Tung Wah Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03060005
Brief Title
Is Sjögren's Syndrome Associated With Meibomian Gland Dysfunction ?
Official Title
Is Sjögren's Syndrome Associated With Meibomian Gland Dysfunction ?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
August 1, 2017 (Anticipated)
Study Completion Date
September 1, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tung Wah Hospital

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
Sjögren's Syndrome, Meibomian Gland Dysfunction
Keywords
Sjögren's syndrome, meibomian gland dysfunction, 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
80 (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)
Tears Naturale Forte
Other Intervention Name(s)
DEXTRAN/HYPROMELLOSE/GLYCERIN
Intervention Description
This medication is used to relieve dry, irritated eyes
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 treatment of the symptoms of dry eye.
Primary Outcome Measure Information:
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
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
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
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
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
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
Secondary Outcome Measure Information:
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
50 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
Chi Zhang, MD,PhD
Phone
+8613790077756
Email
mike0946@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shaolin Du
Phone
+8613711936976
Email
challenge134@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaolin Du, MD,PhD
Organizational Affiliation
Tungwah Hospital of Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tungwah Hospital of Sun Yat-sen University
City
Dongguan
State/Province
Guangdong
ZIP/Postal Code
523000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chi Zhang, MD,PhD
Phone
+8613790077756
Email
mike0946@163.com

12. IPD Sharing Statement

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Is Sjögren's Syndrome Associated With Meibomian Gland Dysfunction ?

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