Sjögren's Syndrome Is Associated With Meibomian Gland Dysfunction

L

Lanzhou University

Status

Unknown

Conditions

Meibomian Gland Dysfunction
Sjögren's Syndrome

Treatments

Drug: liposic
Drug: Tears Naturale Forte

Study type

Interventional

Funder types

Other

Identifiers

NCT03434106
2018A-005

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

Female

Ages

45 to 60 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 4 patient groups

primary Sjögren's syndrome
Experimental group
Description:
The female patients with primary Sjögren's syndrome receive the Tears Naturale Forte and Liposic.
Treatment:
Drug: Tears Naturale Forte
Drug: liposic
secondary Sjögren's syndrome
Experimental group
Description:
The female patients with secondary Sjögren's syndrome receive Tears Naturale Forte and Liposic.
Treatment:
Drug: Tears Naturale Forte
Drug: liposic
meibomian gland dysfunction
Experimental group
Description:
The female patients with meibomian gland dysfunction receive the Tears Naturale Forte and Liposic.
Treatment:
Drug: Tears Naturale Forte
Drug: liposic
control
Experimental group
Description:
the female had no history of autoimmune disease receive the Tears Naturale Forte and Liposic.
Treatment:
Drug: Tears Naturale Forte
Drug: liposic

Trial contacts and locations

1

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Central trial contact

Jingmin Yuan, MD

Data sourced from clinicaltrials.gov

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