Sjogren's SyndromeNCT06406933
Salivary Conductivity Screening for Dry Eye Disease and Sjögren's Syndrome
An observational study of Sjogren's Syndrome and Dry Eye Syndromes, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sjogren's Syndrome, Dry Eye Syndromes
- What is being tested?
- Carbomer Gel/Jelly
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2023to 31 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We recruited adults aged 20 years and older from the outpatient department and divided them into groups.
Who may be able to join
- Adults aged 20 and older
- Patients with normal and dry eye syndrome
Who cannot join
- Hepatitis C
- Acquired immunodeficiency syndrome
- Lymphoma
- Intestinal amyloidosis
- Open pulmonary tuberculosis
- Graft-versus-host disease
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Ophthalmology, Chang Gung Memorial Hospital
Pizi, 613
PeiLun Wu, 886-5-3621000 ext. 2596, peyluenwu@gmail.com
About this study
Official title: Saliva Conductivity as A Novel Screening Test for Dry Eye Disease and Sjögren's Syndrome
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.
Read the detailed 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.
- Conditions
- Sjogren's Syndrome, Dry Eye Syndromes
- Being tested
- Carbomer Gel/Jelly
- Keywords
- dry eye disease, Sjögren syndrome, salivary conductivity, conductivity
- Medical subject headings
- Sjogren's Syndrome, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbomer Gel/JellyDrug
The drug is for dry eye syndrome by providing temporary relief from discomfort and irritation.
| Study group | Role | What they receive |
|---|---|---|
| new-pSS | Newly diagnosed primary Sjögren's syndrome patients Receives: 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. Receives: 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). Receives: Drug: Carbomer Gel/Jelly | |
| normal | Those without symptoms of dry eyes or dry mouth. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2023-2025
Secondary outcomes (1)
Tear Film Break-up Time
to indicate the stability of tear film
Measured: 2023-2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start1 Jul 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren's SyndromeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PeiLun Wu, Principal investigator, Chang Gung Memorial HospitalYungKang Chen, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406933
- Sponsor's protocol ID
- 2022017070
- Status last verified
- May 2024
- First submitted
- 6 May 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saliva Conductivity as A Novel Screening Test for Dry Eye Disease and Sjögren's Syndrome
- ClinicalTrials.gov ID
- NCT06406933
- Acronym / sponsor ID
- 2022017070
- Conditions
- Sjogren's Syndrome, Dry Eye Syndromes
- Keywords
- dry eye disease, Sjögren syndrome, salivary conductivity, conductivity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| new-pSS | – | Drug: Carbomer Gel/JellyNewly diagnosed primary Sjögren's syndrome patients |
| Sjögren's syndrome | – | Drug: Carbomer Gel/JellyPatients diagnosed with Sjögren's syndrome and who have undergone treatment: Need to undergo major illness card registration. |
| dry eye | – | Drug: Carbomer Gel/JellyThose 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). |
| normal | – | –Those without symptoms of dry eyes or dry mouth. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We recruited adults aged 20 years and older from the outpatient department and divided them into groups.
Key inclusion criteria (2 listed)
- Adults aged 20 and older
- Patients with normal and dry eye syndrome
Key exclusion criteria (14 listed)
- Hepatitis C
- Acquired immunodeficiency syndrome
- Lymphoma
- Intestinal amyloidosis
- Open pulmonary tuberculosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbomer Gel/JellyThe drug is for dry eye syndrome by providing temporary relief from discomfort and irritation. | Drug | Sjögren's syndrome, dry eye, new-pSS |
Primary outcome
Ocular Surface Disease Index (OSDI) questionnaire
Time frame: 2023-2025
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.
1 secondary outcome
Tear Film Break-up Time
Time frame: 2023-2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PeiLun Wu principal investigator
Chang Gung Memorial Hospital
YungKang Chen principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sjogren's Syndrome and Dry Eye Syndromes, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YungKang Chen (886-5-3621000 ext. 2596, allenally@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular Surface Disease Index (OSDI) questionnaire (time frame: 2023-2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.