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Is Sjögren's Syndrome Associated With Meibomian Gland Dysfunction ?

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ClinicalTrials.gov Identifier: NCT03060005
Recruitment Status : Unknown
Verified May 2017 by Tung Wah Hospital.
Recruitment status was:  Recruiting
First Posted : February 23, 2017
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
Tung Wah Hospital

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.

Condition or disease Intervention/treatment Phase
Sjögren's Syndrome Meibomian Gland Dysfunction Drug: Tears Naturale Forte Drug: liposic Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Is Sjögren's Syndrome Associated With Meibomian Gland Dysfunction ?
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : August 1, 2017
Estimated Study Completion Date : September 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: primary Sjögren's syndrome
The female patients with primary Sjögren's syndrome receive the Tears Naturale Forte and Liposic.
Drug: Tears Naturale Forte
This medication is used to relieve dry, irritated eyes
Other Name: DEXTRAN/HYPROMELLOSE/GLYCERIN

Drug: 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 treatment of the symptoms of dry eye.
Other Name: Carbomer

Experimental: secondary Sjögren's syndrome
The female patients with secondary Sjögren's syndrome receive Tears Naturale Forte and Liposic.
Drug: Tears Naturale Forte
This medication is used to relieve dry, irritated eyes
Other Name: DEXTRAN/HYPROMELLOSE/GLYCERIN

Drug: 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 treatment of the symptoms of dry eye.
Other Name: Carbomer

Experimental: meibomian gland dysfunction
The female patients with meibomian gland dysfunction receive the Tears Naturale Forte and Liposic.
Drug: Tears Naturale Forte
This medication is used to relieve dry, irritated eyes
Other Name: DEXTRAN/HYPROMELLOSE/GLYCERIN

Drug: 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 treatment of the symptoms of dry eye.
Other Name: Carbomer

Experimental: control
the female had no history of autoimmune disease receive the Tears Naturale Forte and Liposic.
Drug: Tears Naturale Forte
This medication is used to relieve dry, irritated eyes
Other Name: DEXTRAN/HYPROMELLOSE/GLYCERIN

Drug: 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 treatment of the symptoms of dry eye.
Other Name: Carbomer




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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).

  5. 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.

  6. 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.


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   50 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03060005


Contacts
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Contact: Chi Zhang, MD,PhD +8613790077756 mike0946@163.com
Contact: Shaolin Du +8613711936976 challenge134@126.com

Locations
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China, Guangdong
Tungwah Hospital of Sun Yat-sen University Recruiting
Dongguan, Guangdong, China, 523000
Contact: Chi Zhang, MD,PhD    +8613790077756    mike0946@163.com   
Sponsors and Collaborators
Tung Wah Hospital
Investigators
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Principal Investigator: Shaolin Du, MD,PhD Tungwah Hospital of Sun Yat-Sen University

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Responsible Party: Tung Wah Hospital
ClinicalTrials.gov Identifier: NCT03060005     History of Changes
Other Study ID Numbers: 2017DHLL001
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tung Wah Hospital:
Sjögren's syndrome
meibomian gland dysfunction
dry eye disease
Additional relevant MeSH terms:
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Sjogren's Syndrome
Syndrome
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Dextrans
Glycerol
Anticoagulants
Plasma Substitutes
Blood Substitutes
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs