Sjogren's SyndromeAST/SSNCT06013436
AST Combined With 0.05% Cyclosporin Eye Drop Improve Corneal Nerve Density in Patients With SS Dry Eye
An observational study of Sjogren's Syndrome and Dry Eye, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The objective of the present study was to evaluate the efficacy of autologous serum tears combined with 0.05% cyclosporin eye drop in treating Sjögren's syndrome dry eye and their effect on corneal nerves. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sjogren's Syndrome, Dry Eye, Ocular Surface Disease
- What is being tested?
- Autologous serum tears combined with 0.05% cyclosporin eye drop
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 1 Jun 2023
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From June 2022 to June 2023, moderate and severe dry eye patients with Sjogren's syndrome were treated in the Department of Ophthalmology and Rheumatology and Immunology of the Hospital of Chengdu University of Traditional Chinese Medicine.
Who may be able to join
- Patients were diagnosed with SS according to the classification criteria defined by the American-European Consensus Group for the diagnosis of SS and also diagnosed with severe DED based on the consensus of Chinese dry eye experts.
- Age 18-65 years old.
- Controlled collagen disease by the same rheumatologists at least 3 months prior to the initiation of the trial.
- At least one eye that failed to respond to previous treatments including lartificial tears, topical ocular NSAIDs or corticosteroids.
Who cannot join
- Patients with DED related to meibomian gland dysfunction, blepharitis, abnormal blinking, conjunctival relaxation or any other diseases besides SS.
- Diagnosed with allergic conjunctivitis, uveitis, ocular hypertension, retinopathy and other eye diseases.
- Those who have a history of previous ocular oprations, eye injuries or contact lenses usage.
- Known hypersensitivity to experimental drugs or any of its ingredients.
- Necessity to modify the systemic treatment of previous diseases during the trial.
- Pregnancy or lactation.
- Severe systemic disease.
Trial locations and contacts
1 site in 1 country.
China1 site
Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, 610072
About this study
Official title: Autologous Serum Tears Combined With 0.05% Cyclosporin Eye Drop Improve Corneal Nerve Density in Patients With Sjögren's Syndrome Dry Eye
The objective of the present study was to evaluate the efficacy of autologous serum tears combined with 0.05% cyclosporin eye drop in treating Sjögren's syndrome dry eye and their effect on corneal nerves. We assessed the impact of 12-week AST combined with 0.05% cyclosporin eye drop treatment on signs, symptoms, and sub-basal nerve density (SND) in patients with dry eyes related to Sjogren's syndrome.
Read the detailed description
Objective: To describe the clinical efficacy and safety of the treatment of Sjögren's syndrome dry eye using autologous serum tears combined with 0.05% cyclosporin eye drop and to evaluate their effect on corneal nerves.
Design: Singal-center, prospective, observational study. Patients and methods: Thirty eyes of fifteen patients with dry eye related to Sjögren syndrome were enrolled in this study. Following a 4-week washout period, the treatment was inverted for each patient for the same duration and treatment. Ocular Surface Disease Index (OSDI), tear film, break-up time, corneal staining with the use of fluorescein, Schirmer's test and corneal confocal microscopy were investigated.
- Conditions
- Sjogren's Syndrome, Dry Eye, Ocular Surface Disease
- Being tested
- Autologous serum tears combined with 0.05% cyclosporin eye drop
- Keywords
- autologous serum tears, 0.05% cyclosporin eye drop, cornea nerves
- 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.
Autologous serum tears combined with 0.05% cyclosporin eye dropDrug
Also called Ciclosporin Eye Drops(II)（Cyclone® ，SHENYANG XINGQI PHARMACEUTICAL Co., Ltd.）
All patients administrated autologous serum tears twelve times daily（per hour） and 0.05% cyclosporin eye drop twice times daily in each eye for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Autologous serum tears, twelve times daily（per hour）, 12weeks. 0.05% cyclosporin eye drop, twice times daily, 12weeks. Receives: Drug: Autologous serum tears combined with 0.05% cyclosporin eye drop |
What is being measured
The primary outcome is the main question the study is designed to answer.
cornea nerves
cornea sub-basal nerve density
Measured: 12 weeks
cornea staining score
to evaluate corneal epithelial repair（0= no staining; 1= less than 5 staining points; 2= more than 5 and less than 30 staining points within the range of two quadrants; and 3= staining exceeding two quadrants or staining points more than 30）
Measured: 4 weeks
Secondary outcomes (3)
Ocular Surface Disease Index (OSDI)
to assess the quality of life and clinical symptom；The survey generated a score ranging 0-100 (0 indicated absence of eye discomfort and 100 represented maximum eye discomfort)
Measured: 4 weeks
Schirmer's test
to assess tear flow
Measured: 4 weeks
tear film breakup time (TBUT)
to assess tear film stability
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start1 Jun 2022
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
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.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiachun Hu, Chengdu University of Traditional Chinese Medicine
- Investigators
- Jiachun Hu, Resident, Principal investigator, Chengdu University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013436
- Sponsor's protocol ID
- 22LLZX10
- Acronym
- AST/SS
- Status last verified
- Aug 2023
- First submitted
- 26 Jul 2023
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Serum Tears Combined With 0.05% Cyclosporin Eye Drop Improve Corneal Nerve Density in Patients With Sjögren's Syndrome Dry Eye
- ClinicalTrials.gov ID
- NCT06013436
- Acronym / sponsor ID
- AST/SS / 22LLZX10
- Conditions
- Sjogren's Syndrome, Dry Eye, Ocular Surface Disease
- Keywords
- autologous serum tears, 0.05% cyclosporin eye drop, cornea nerves
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 28 Aug 2023 (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.
The objective of the present study was to evaluate the efficacy of autologous serum tears combined with 0.05% cyclosporin eye drop in treating Sjögren's syndrome dry eye and their effect on corneal nerves. We assessed the impact of 12-week AST combined with 0.05% cyclosporin eye drop treatment on signs, symptoms, and sub-basal nerve density (SND) in patients with dry eyes related to Sjogren's syndrome.
Detailed description
Objective: To describe the clinical efficacy and safety of the treatment of Sjögren's syndrome dry eye using autologous serum tears combined with 0.05% cyclosporin eye drop and to evaluate their effect on corneal nerves.
Design: Singal-center, prospective, observational study. Patients and methods: Thirty eyes of fifteen patients with dry eye related to Sjögren syndrome were enrolled in this study. Following a 4-week washout period, the treatment was inverted for each patient for the same duration and treatment. Ocular Surface Disease Index (OSDI), tear film, break-up time, corneal staining with the use of fluorescein, Schirmer's test and corneal confocal microscopy were investigated.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Drug: Autologous serum tears combined with 0.05% cyclosporin eye dropAutologous serum tears, twelve times daily（per hour）, 12weeks. 0.05% cyclosporin eye drop, twice times daily, 12weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From June 2022 to June 2023, moderate and severe dry eye patients with Sjogren's syndrome were treated in the Department of Ophthalmology and Rheumatology and Immunology of the Hospital of Chengdu University of Traditional Chinese Medicine.
Key inclusion criteria (4 listed)
- Patients were diagnosed with SS according to the classification criteria defined by the American-European Consensus Group for the diagnosis of SS and also diagnosed with severe DED based on the consensus of Chinese dry eye experts.
- Age 18-65 years old.
- Controlled collagen disease by the same rheumatologists at least 3 months prior to the initiation of the trial.
- At least one eye that failed to respond to previous treatments including lartificial tears, topical ocular NSAIDs or corticosteroids.
Key exclusion criteria (7 listed)
- Patients with DED related to meibomian gland dysfunction, blepharitis, abnormal blinking, conjunctival relaxation or any other diseases besides SS.
- Diagnosed with allergic conjunctivitis, uveitis, ocular hypertension, retinopathy and other eye diseases.
- Those who have a history of previous ocular oprations, eye injuries or contact lenses usage.
- Known hypersensitivity to experimental drugs or any of its ingredients.
- Necessity to modify the systemic treatment of previous diseases during the trial.
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 |
|---|---|---|
| Autologous serum tears combined with 0.05% cyclosporin eye dropAlso: Ciclosporin Eye Drops(II)（Cyclone® ，SHENYANG XINGQI PHARMACEUTICAL Co., Ltd.）All patients administrated autologous serum tears twelve times daily（per hour） and 0.05% cyclosporin eye drop twice times daily in each eye for 12 weeks. | Drug | Experimental group |
Primary outcome
cornea nerves
Time frame: 12 weeks
cornea sub-basal nerve density
cornea staining score
Time frame: 4 weeks
to evaluate corneal epithelial repair（0= no staining; 1= less than 5 staining points; 2= more than 5 and less than 30 staining points within the range of two quadrants; and 3= staining exceeding two quadrants or staining points more than 30）
3 secondary outcomes
Ocular Surface Disease Index (OSDI)
Time frame: 4 weeks
Schirmer's test
Time frame: 4 weeks
tear film breakup time (TBUT)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
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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.
Jiachun Hu, Resident principal investigator
Chengdu University of Traditional Chinese Medicine
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, run by Chengdu University of Traditional Chinese Medicine 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 28 Aug 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cornea nerves (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 28 Aug 2023.