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

NCT06406933 | Recruiting

• 1 other identifier: 2022017070
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sjogren's Syndrome; Dry Eye Syndromes

Keywords

dry eye disease; Sjögren syndrome; salivary conductivity; conductivity

Outcome Measures

Primary Outcomes (1)

• Ocular Surface Disease Index (OSDI) questionnaire

  To evaluate the severity of dry eye symptoms.Thus, the OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.

  2023-2025

Secondary Outcomes (1)

• Tear Film Break-up Time

  2023-2025

Other Outcomes (1)

• Schirmer test

  2023-2025

Study Arms (4)

new-pSS

Newly diagnosed primary Sjögren's syndrome patients

Drug: Carbomer Gel/Jelly

Sjögren's syndrome

Patients diagnosed with Sjögren's syndrome and who have undergone treatment: Need to undergo major illness card registration.

Drug: Carbomer Gel/Jelly

dry eye

Those with symptoms of dry eyes (such as a sensation of foreign bodies in the eyes, sensitivity to light, tearing, etc.) but without symptoms of dry mouth (such as frequent drinking of water).

Drug: Carbomer Gel/Jelly

normal

Those without symptoms of dry eyes or dry mouth.

Interventions

Carbomer Gel/Jelly DRUG

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

Sjögren's syndrome; dry eye; new-pSS

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We recruited adults aged 20 years and older from the outpatient department and divided them into groups.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Department of Ophthalmology, Chang Gung Memorial Hospital

Pizi, 613, Taiwan

RECRUITING

MeSH Terms

Conditions

Sjogren's Syndrome; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• PeiLun Wu

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

• YungKang Chen

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YungKang Chen

CONTACT

886-5-3621000; allenally@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: July 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: December 4, 2024

Record last verified: 2024-05

Locations

TW (1)