Is Sjögren's Syndrome Associated With Meibomian Gland Dysfunction ?

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: Meibomian Gland Dysfunction; Sjögren's Syndrome
• Intervention / Treatment: Drug: Tears Naturale Forte; Drug: liposic

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Dongguan, Guangdong, China, 523000
      • Recruiting
      • Tungwah Hospital of Sun Yat-Sen University
      • Contact: Chi Zhang, MD,PhD; Phone Number: +8613790077756; Email: mike0946@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

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.	Drug: Tears Naturale Forte; This medication is used to relieve dry, irritated eyes; Other Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: Carbomer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 3 months after tear substitutes apply
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).	up to 3 months after tear substitutes apply
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.	up to 3 months after tear substitutes apply
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.	up to 3 months after tear substitutes apply
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.	up to 3 months after tear substitutes apply
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	up to 3 months after tear substitutes apply

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 3 months after tear substitutes apply

Collaborators and Investigators

• Sponsor: Tung Wah Hospital
• Investigators: Principal Investigator: Shaolin Du, MD,PhD, Tungwah Hospital of Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: January 23, 2017
• First Submitted That Met QC Criteria: February 16, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): May 16, 2017
• Last Update Submitted That Met QC Criteria: May 14, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Sjögren's syndrome; meibomian gland dysfunction; dry eye disease
• 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: 2017DHLL001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No