Salivary Conductivity Screening for Primary Sjögren's Syndrome

Dry Eye Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06406933
• Other study ID #: 2022017070
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: March 31, 2026

Study information

• Verified date: May 2024
• Source: Chang Gung Memorial Hospital
• Contact: PeiLun Wu
• Phone: 886-5-3621000
• Email: peyluenwu[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Dry eye disease is prevalent among patients presenting with ocular surface diseases, with rates ranging from 5-50% in recent years. In the United States, approximately sixteen million people are affected by this condition. Dry eye patients often experience ocular surface damage, such as punctate epithelial keratitis, superior limbic keratoconjunctivitis, and filamentary keratitis, due to impaired tear lubrication of the cornea. The etiology of dry eye disease is multifactorial, making diagnosis challenging and requiring comprehensive medical history inquiry and various ocular surface staining techniques. In Taiwan, fluorescein strips are commonly used to assess corneal damage severity and tear break-up time to evaluate tear film abnormalities. Recent research utilizing in vivo confocal microscopy has revealed lower sub-basal nerve fiber numbers and higher dendritic cell densities in the cornea of dry eye patients with immune causes.

Dry eye disease was redefined as a multifactorial condition at the International Dry Eye Workshop II (DEWS II) in 2017, categorized into aqueous deficient dry eye (ADDE) and evaporative dry eye (EDE). In Taiwan, Sjögren's Syndrome (SS) is a primary cause of aqueous deficient dry eye, occurring in approximately 4.8% of dry eye disease patients. SS is a chronic autoimmune disease characterized by lymphocyte infiltration of exocrine glands like the salivary and lacrimal glands. If SS occurs without other autoimmune diseases, it is referred to as primary Sjögren's Syndrome (pSS). Globally, the prevalence of pSS is approximately 60.82 per 100,000 people, with an incidence rate of 6.92 per 100,000 people. Conventional diagnostic methods for salivary dysfunction, such as salivary scintigraphy and parotid sialography, are costly and time-consuming. Following SS diagnosis, comprehensive blood tests, including CBC, DC, ESR, CRP, BUN, Cre, Na, K, HCO3, and serum immunomarkers (ANA, anti-SSA/Ro, anti-SSB/La, RF), are typically advised. The study aims to investigate saliva conductivity as a diagnostic and disease activity monitoring tool for primary Sjögren's syndrome in dry eye syndrome patients and its association with ocular surface damage and tear secretion volume.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Adults aged 20 and older

2. Patients with normal and dry eye syndrome

Exclusion Criteria:

1. Hepatitis C

2. Acquired immunodeficiency syndrome

3. Lymphoma

4. Intestinal amyloidosis

5. Open pulmonary tuberculosis

6. Graft-versus-host disease

7. Rheumatoid or lupus erythematosus and other autoimmune diseases

8. IgG4-related diseases

9. Head and neck radiation therapy

10. Glaucoma

11. History of infectious keratitis

12. History of ophthalmic surgery

13. Wear contact lenses in the month before the trial

14. Chew betel nuts or smoke within one month before the trial

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Sjogren's Syndrome
• Syndrome

Intervention

Drug:
• Carbomer Gel/Jelly
The drug is for dry eye syndrome by providing temporary relief from discomfort and irritation.

Locations

Country	Name	City	State
Taiwan	Department of Ophthalmology, Chang Gung Memorial Hospital	Pizi

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Schirmer test	to assess tear production.	2023-2025
Primary	Ocular Surface Disease Index (OSDI) questionnaire	to evaluate the severity of dry eye symptoms	2023-2025
Secondary	Tear Film Break-up Time	to indicate the stability of tear film	2023-2025