RecruitingNCT06406933

Salivary Conductivity Screening for Dry Eye Disease and Sjögren's Syndrome

Saliva Conductivity as A Novel Screening Test for Dry Eye Disease and Sjögren's Syndrome


Sponsor

Chang Gung Memorial Hospital

Enrollment

200 participants

Start Date

Jul 1, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

Dry eye disease, or keratoconjunctivitis sicca, is one of the most common diseases encountered at ophthalmologic clinics. Patient with dry eye disease commonly presented foreign body sensation, red eye, blurred vision, etc. Numerous treatments for dry eye disease are proposed due to its multifactorial etiology. Sjögren syndrome, which is one of the main etiologies of dry eye disease, is an autoimmune disease characterized by dysfunction of lacrimal and salivary glands. Although dry eye status can be easily examined by ocular surface staining, the methods quantifying salivary flow rate are hard to performed clinically, such as salivary gland scintigraphy and sialometry. Furthermore, disease activity could only rely on serum markers or salivary gland ultrasound. Recently, a portable device measuring salivary conductivity is believed to assess fluid status and renal function. Interestingly, the composition of salivary electrolytes in patients with Sjögren syndrome is different from those with other causes of hyposalivation. Thus, this study aims to evaluate whether salivary conductivity in combination with ocular surface staining can be a non-invasive diagnostic test for primary Sjögren syndrome among people with dry eye disease.


Eligibility

Min Age: 20 YearsMax Age: 80 Years

Inclusion Criteria2

  • Adults aged 20 and older
  • Patients with normal and dry eye syndrome

Exclusion Criteria14

  • Hepatitis C
  • Acquired immunodeficiency syndrome
  • Lymphoma
  • Intestinal amyloidosis
  • Open pulmonary tuberculosis
  • Graft-versus-host disease
  • Rheumatoid or lupus erythematosus and other autoimmune diseases
  • IgG4-related diseases
  • Head and neck radiation therapy
  • Glaucoma
  • History of infectious keratitis
  • History of ophthalmic surgery
  • Wear contact lenses in the month before the trial
  • Chew betel nuts or smoke within one month before the trial

Interventions

DRUGCarbomer Gel/Jelly

The drug is for dry eye syndrome by providing temporary relief from discomfort and irritation.


Locations(1)

Department of Ophthalmology, Chang Gung Memorial Hospital

Pizi, Taiwan

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NCT06406933


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