Screening for dry eye disease and Sjögren's syndrome using salivary conductivity
Saliva Conductivity as A Novel Screening Test for Dry Eye Disease and Sjögren's Syndrome
This study is testing if measuring saliva can help identify adults with dry eye disease and Sjögren's syndrome more easily.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | Chang Gung Memorial Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Pizi) |
| Trial ID | NCT06406933 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the relationship between salivary conductivity and the presence of dry eye disease and Sjögren's syndrome. It involves measuring salivary conductivity using a portable device to evaluate fluid status and potential dysfunction of salivary glands. The study will include adults aged 20 and older, both with normal and dry eye syndrome, while excluding individuals with certain autoimmune diseases and other specified conditions. The goal is to improve diagnostic methods for these conditions, which are often challenging to assess clinically.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 20 and older who either have normal eye conditions or are diagnosed with dry eye syndrome.
Not a fit: Patients with specific autoimmune diseases or those who have undergone recent ophthalmic surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive and efficient method for diagnosing dry eye disease and Sjögren's syndrome.
How similar studies have performed: While the approach of using salivary conductivity for diagnosis is relatively novel, similar studies have shown promise in utilizing salivary biomarkers for various conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Pizi
- Department of Ophthalmology, Chang Gung Memorial Hospital — Pizi, Taiwan (Recruiting)
Study contacts
- Principal investigator: PeiLun Wu — Chang Gung Memorial Hospital
- Study coordinator: YungKang Chen
- Email: allenally@gmail.com
- Phone: 886-5-3621000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.