Sjögren's Syndrome Is Associated With Meibomian Gland Dysfunction

NCT ID: NCT03434106

Last Updated: 2018-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-10

Study Completion Date

2018-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Meibomian Gland Dysfunction Sjögren's Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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primary Sjögren's syndrome

The female patients with primary Sjögren's syndrome receive the Tears Naturale Forte and Liposic.

Group Type EXPERIMENTAL

liposic

Intervention Type DRUG

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

Tears Naturale Forte

Intervention Type DRUG

This medication is used to relieve dry, irritated eyes

secondary Sjögren's syndrome

The female patients with secondary Sjögren's syndrome receive Tears Naturale Forte and Liposic.

Group Type EXPERIMENTAL

liposic

Intervention Type DRUG

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

Tears Naturale Forte

Intervention Type DRUG

This medication is used to relieve dry, irritated eyes

meibomian gland dysfunction

The female patients with meibomian gland dysfunction receive the Tears Naturale Forte and Liposic.

Group Type EXPERIMENTAL

liposic

Intervention Type DRUG

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

Tears Naturale Forte

Intervention Type DRUG

This medication is used to relieve dry, irritated eyes

control

the female had no history of autoimmune disease receive the Tears Naturale Forte and Liposic.

Group Type EXPERIMENTAL

liposic

Intervention Type DRUG

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

Tears Naturale Forte

Intervention Type DRUG

This medication is used to relieve dry, irritated eyes

Interventions

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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

Intervention Type DRUG

Tears Naturale Forte

This medication is used to relieve dry, irritated eyes

Intervention Type DRUG

Other Intervention Names

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Carbomer DEXTRAN/HYPROMELLOSE/GLYCERIN

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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LanZhou University

OTHER

Sponsor Role lead

Responsible Party

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Jingmin Yuan, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Lanzhou University Second Hospital

Lanzhou, Gansu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jingmin Yuan, MD

Role: CONTACT

+(86)15002626556

Facility Contacts

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Jingmin Yuan

Role: primary

+(86)15002626556

Other Identifiers

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2018A-005

Identifier Type: -

Identifier Source: org_study_id

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