Dry EyepSSNCT05605314
Clinical Cohort Study in Patients With Different Subtypes of Primary Sjogren Syndrome Related Dry Eye
An observational study of Dry Eye, run by Peking University Third Hospital at 1 site in China.
Trial summary
Primary Sjögren's syndrome is a chronic autoimmune disease that primarily involves exocrine glands, most commonly manifested in dry eye, dry mouth, and in other systems of the body. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Cyclosporine
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: pSS and DED patients who visited the dry eye clinic of Peking University Third Hospital from January 2021 to January 2028.
Who may be able to join
- All enrolled DED participants met the criterion of TFOS DEWS II Definition and Classification Report and pSS-DED group also met 2016ACR/EULAR pSS diagnosis and classification consensus.
Who cannot join
- (1) patients were diagnosed as any rheumatic or systematic diseases that would probably affect tear function except for pSS and DED. (2) had a history of ocular trauma or surgery. (3) had a history of wearing contact lens. (4) had concomitant ocular lesions such as acute inflammation or infection, glaucoma or eyelid abnormalities. (5) cannot cooperate properly or finish related examinations.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Weizhen Zeng contact
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing
Yun Feng, PhD
About this study
Primary Sjögren's syndrome is a chronic autoimmune disease that primarily involves exocrine glands, most commonly manifested in dry eye, dry mouth, and in other systems of the body.
Read the detailed description
Patients usually first seek for the ophthalmologist for severe dry eye symptoms, and most clinicians are ill-informed about Sjögren's syndrome dry eye disease (SS-DED), which can lead to missed diagnoses and misdiagnoses. Clinically, there are not many types of patients with pSS and the number of in-depth studies is small. Meanwhile, there are no specific drugs for the treatment of SS-DED, and most patients need to be treated with multiple methods to understand which methods are most effective. In this study, by establishing a clinical cohort of patients with different subtypes of dry eye with pSS, we explored the association between the primary organs affected by pSS and various biomarkers related to tear fluid and blood, and the association between the primary organs affected by pSS, tear components and blood markers and the severity of ocular involvement, symptom progression and prognosis. This study initially constructs a special cohort of patients with pSS ocular involvement, which may explain its pathogenesis from a new perspective in diagnose, classification and treatment.
- Conditions
- Dry Eye
- Being tested
- Cyclosporine
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclosporineOther
eye drop
| Study group | Role | What they receive |
|---|---|---|
| pSS-DED | DED patients who visited the dry eye clinic of Peking University Third Hospital from 2021 to May 2028. The pSS-DED patients further accepted the diagnosis of rheumatology department. All enrolled DED participants met the criterion of TFOS DEWS II Definition and Classification Report and pSS-DED group also met 2016ACR/EULAR pSS diagnosis and classification consensus. Receives: Other: Cyclosporine | |
| nss-DED | DED patients who visited the dry eye clinic of Peking University Third Hospital from 2021 to May 2028. Receives: Other: Cyclosporine |
What is being measured
The primary outcome is the main question the study is designed to answer.
ESSDAI
Fill out the scale
Measured: 2021.1~2028.1
Secondary outcomes (2)
Schirmer
The Schirmer I test was performed without topical anesthesia after all other examinations by slit lamp had been completed at least 15 minutes to avoid any effect of keratoconjunctival staining. A Schirmer test strip (Liaoning Meizilin Pharmaceutical Co., Ltd.) was placed on the outer one third of the temporal lower conjunctival fornix for 5 min. The strip was then removed, and the length of the wet filter paper was recorded in millimeters.
Measured: 2021.1~2028.1
BUT，TMH
All participants were instilled a minimal volume fluorescein into the inferior temporal tear meniscus by fluorescein sodium ophthalmic test paper (Liaoning Meizilin Pharmaceutical Co., Ltd.) for the evaluation of tear menicus height (TMH) and fluorescein tear break-up time (FBUT) during slit lamp examination. Then, patients were asked to blink several times to ensure adequate mixing of the fluorescein dye with the tears. Under the cobalt blue light of the slit lamp microscope, TMH were recorded and the time interval between the last complete blink and the appearance of the first corneal dark spot was timed using a stopwatch. The average of three measurements was recorded as the FBUT.
Measured: 2021.1~2028.1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start1 Jan 2021
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liyuan Tao, PhD, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05605314
- Sponsor's protocol ID
- fengyun77470
- Acronym
- pSS
- Status last verified
- Sep 2022
- First submitted
- 30 Oct 2022
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Cohort Study in Patients With Different Subtypes of Primary Sjogren Syndrome Related Dry Eye
- ClinicalTrials.gov ID
- NCT05605314
- Acronym / sponsor ID
- pSS / fengyun77470
- Conditions
- Dry Eye
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 4 Nov 2022 (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.
Primary Sjögren's syndrome is a chronic autoimmune disease that primarily involves exocrine glands, most commonly manifested in dry eye, dry mouth, and in other systems of the body.
Detailed description
Patients usually first seek for the ophthalmologist for severe dry eye symptoms, and most clinicians are ill-informed about Sjögren's syndrome dry eye disease (SS-DED), which can lead to missed diagnoses and misdiagnoses. Clinically, there are not many types of patients with pSS and the number of in-depth studies is small. Meanwhile, there are no specific drugs for the treatment of SS-DED, and most patients need to be treated with multiple methods to understand which methods are most effective. In this study, by establishing a clinical cohort of patients with different subtypes of dry eye with pSS, we explored the association between the primary organs affected by pSS and various biomarkers related to tear fluid and blood, and the association between the primary organs affected by pSS, tear components and blood markers and the severity of ocular involvement, symptom progression and prognosis. This study initially constructs a special cohort of patients with pSS ocular involvement, which may explain its pathogenesis from a new perspective in diagnose, classification and treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pSS-DED | – | Other: CyclosporineDED patients who visited the dry eye clinic of Peking University Third Hospital from 2021 to May 2028. The pSS-DED patients further accepted the diagnosis of rheumatology department. All enrolled DED participants met the criterion of TFOS DEWS II Definition and Classification Report and pSS-DED group also met 2016ACR/EULAR pSS diagnosis and classification consensus. |
| nss-DED | – | Other: CyclosporineDED patients who visited the dry eye clinic of Peking University Third Hospital from 2021 to May 2028. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- pSS and DED patients who visited the dry eye clinic of Peking University Third Hospital from January 2021 to January 2028.
Key inclusion criteria (1 listed)
- All enrolled DED participants met the criterion of TFOS DEWS II Definition and Classification Report and pSS-DED group also met 2016ACR/EULAR pSS diagnosis and classification consensus.
Key exclusion criteria (1 listed)
- (1) patients were diagnosed as any rheumatic or systematic diseases that would probably affect tear function except for pSS and DED. (2) had a history of ocular trauma or surgery. (3) had a history of wearing contact lens. (4) had concomitant ocular lesions such as acute inflammation or infection, glaucoma or eyelid abnormalities. (5) cannot cooperate properly or finish related examinations.
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 |
|---|---|---|
| Cyclosporineeye drop | Other | nss-DED, pSS-DED |
Primary outcome
ESSDAI
Time frame: 2021.1~2028.1
Fill out the scale
2 secondary outcomes
Schirmer
Time frame: 2021.1~2028.1
BUT，TMH
Time frame: 2021.1~2028.1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Weizhen Zeng contact
Liyuan Tao, PhD study chair
Peking University Third 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 Dry Eye, run by Peking University Third Hospital at 1 site in China.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 4 Nov 2022. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yun Feng, PhD (13911572425, superjune@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ESSDAI (time frame: 2021.1~2028.1). 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 Nov 2022.