Dry Eye DiseaseNCT07171710
Efficacy of 0.05% Cyclosporine A Eye Drops Combined With Absorbable Tear Duct Plugs in the Treatment of Dry Eye in Sjögren's Syndrom
A study testing 0.05% Cyclosporine Eye Drops and Smart plug absorbable lacrimal duct plugs in people with Dry Eye Disease, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
To study the effectiveness of 0.05% cyclosporine A eye drops in combination with smart plug absorbable lacrimal duct plugs in the monotherapy of cyclosporine for SSDE. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- 0.05% Cyclosporine Eye Drops and Smart plug absorbable lacrimal duct plugs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 31 Mar 2026
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patients aged ≥18 years who had a confirmed diagnosis of Sjögren's syndrome (SS).
- Dry eye diagnosis required both subjective and objective criteria: participants presented with one or more ocular surface symptoms such as dryness, foreign body sensation, burning, fatigue, discomfort, redness, or fluctuating vision, with an Ocular Surface Disease Index (OSDI) score of ≥13; Noninvasive Tear Break-Up Time (NIBUT)≤10s and Schirmer I test≤ 5 mm/5 min
- voluntarily participate in this study and sign written informed consent
Who cannot join
- Any patient with structural abnormalities (eyelid scars, entropion, trichiasis, etc.);
- Patients with any inflammation or active structural changes in the iris or anterior chamber;
- Glaucoma;
- Patients who have undergone previous ophthalmic surgery or have undergone timely closure;
- Patients using any topical medications other than artificial tears, 0.1% flumirone eye drops, and 0.05% cyclosporine A eye drops;
- Patients who received any systemic or topical antibacterial or anti-inflammatory drug treatment 90 days before the start of the study;
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- Patients wearing contact lenses;
- Patients with corneal infection;
- Corneal diseases (marginal ulcers, opacity, scars, bullous keratopathy, conjunctival laxity, eyelid ball adhesions or tumors);
- Pregnancy;
- Study the changes of immunosuppressive system treatment in the first 90 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of 0.05% Cyclosporine A Plus Absorbable Punctal Plugs Versus 0.05% Cyclosporine A Monotherapy in Sjögren's Syndrome-Associated Dry Eye: A Paired-Eye Study
To study the effectiveness of 0.05% cyclosporine A eye drops in combination with smart plug absorbable lacrimal duct plugs in the monotherapy of cyclosporine for SSDE.
Read the detailed description
Participants meeting all eligibility criteria were enrolled and randomized to receive combined treatment (0.05% cyclosporine A plus absorbable punctal plug) in one eye and 0.05% cyclosporine A monotherapy in the contralateral eye. Eye allocation (left or right) was determined using block randomization with a fixed block size of two, implemented via an online randomization tool (www.sealedenvelope.com). The randomization sequence was generated in advance by an independent biostatistician who was not involved in patient care or data analysis.
Treatment allocation was concealed using sequentially numbered, opaque, sealed envelopes (SNOSE), which were prepared by an independent biostatistician not involved in patient care or outcome assessment. At the time of enrollment, a study coordinator opened the next envelope in sequence to determine which eye would receive the combined treatment. The contralateral eye automatically received cyclosporine A monotherapy.
To maintain masking, the ophthalmologists responsible for outcome assessment (including ocular surface staining, tear film measurements, and in vivo confocal microscopy) were blinded to the treatment allocation. Participants were informed that both eyes would receive active treatment and were not informed of the specific allocation. The investigators performing plug insertion and administering cyclosporine A were not involved in any clinical evaluations.
A total of 30 patients with Sjögren's syndrome-associated dry eye (SSDE) were planned for enrollment. The sample size calculation was based on a paired-eye design, in which each participant served as their own control. The calculation assumed a two-sided significance level of 0.05 (α = 0.05) and a statistical power of 95% (β = 0.05), aiming to detect a clinically meaningful difference in ocular surface parameters (e.g., tear breakup time or symptom scores) between the two eyes. The estimated required sample size accounted for potential dropouts and was deemed sufficient to identify within-subject differences while minimizing variability due to inter-individual factors such as disease severity, lifestyle, and systemic autoimmune status.
- Conditions
- Dry Eye Disease
- Being tested
- 0.05% Cyclosporine Eye Drops, Smart plug absorbable lacrimal duct plugs
- Keywords
- dry eye disease, Absorbable Tear Duct Plugs, 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.
0.05% Cyclosporine Eye DropsDrug
Cyclosporin A 0.05% eye drops were administered twice daily to both eyes
Smart plug absorbable lacrimal duct plugsDevice
The lacrimal duct embolization implant is performed by partially sealing the tear discharge duct to increase the lubrication of natural tears on the eye surface.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Other | One eye was randomized to recieve a Smart plug absorbable lacrimal duct plugs, and cyclosporin A 0.05% cyclosporine A eye drops were administered three times daily to both eyes. Receives: Drug: 0.05% Cyclosporine Eye Drops |
| Control group | Other | cyclosporin A 0.05% cyclosporine A eye drops were administered three times daily to both eyes. Receives: Drug: 0.05% Cyclosporine Eye Drops; Device: Smart plug absorbable lacrimal duct plugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Ocular Surface Disease Index (OSDI) score
The Ocular Surface Disease Index (OSDI) is a tool used for screening and diagnosing patients with dry eye syndrome. It assesses the severity of dry eye, covering three dimensions: ocular symptoms, visual function and environmental triggers
Measured: Assessed after 3 months of the trial
VAS score
A swimming ruler of about 10cm in length was used, with 10 scales on one side and "0" and "10" ends, respectively, with 0 indicating no pain and 10 indicating the most severe pain that was unbearable.
Measured: Assessed after 3 months of the trial
BUT
Tear film break-up time,It is a tear stability test
Measured: Assessed after 6 months of the trial
tear river height
The concave arc formed at the junction of tears and eyelid margin was observed under a slit lamp microscope, and the tear secretion was indirectly evaluated by measuring the tear retention height
Measured: Assessed after 6 months of the trial
IVCM examination
It can observe the physiological and pathological changes of ocular surface tissues and cell structures in vivo, and has wide applications in the diagnosis and treatment evaluation of infectious keratitis, ocular surface assessment of dry eye disease, evaluation of the therapeutic effect of ocular surface surgery, and early screening of diabetes.
Measured: Assessed after 6 months of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start1 Mar 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry Eye DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi Zhang, Study director, Tianjin Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171710
- Sponsor's protocol ID
- zhangyi2024-1
- Status last verified
- Oct 2024
- First submitted
- 8 Sep 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dong Y, Cao JF, Li ZC, Yang XY, Chen L. Enhanced efficacy of 0.05% cyclosporine a combined with absorbable punctal plugs in Sjogren's syndrome-associated dry eye: a paired-eye clinical trial. Front Med (Lausanne). 2026 Jan 6;12:1674647. doi: 10.3389/fmed.2025.1674647. eCollection 2025.
PubMed 41567664
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of 0.05% Cyclosporine A Plus Absorbable Punctal Plugs Versus 0.05% Cyclosporine A Monotherapy in Sjögren's Syndrome-Associated Dry Eye: A Paired-Eye Study
- ClinicalTrials.gov ID
- NCT07171710
- Acronym / sponsor ID
- zhangyi2024-1
- Conditions
- Dry Eye Disease
- Keywords
- dry eye disease, Absorbable Tear Duct Plugs, Cyclosporine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 12 Sep 2025 (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.
To study the effectiveness of 0.05% cyclosporine A eye drops in combination with smart plug absorbable lacrimal duct plugs in the monotherapy of cyclosporine for SSDE.
Detailed description
Participants meeting all eligibility criteria were enrolled and randomized to receive combined treatment (0.05% cyclosporine A plus absorbable punctal plug) in one eye and 0.05% cyclosporine A monotherapy in the contralateral eye. Eye allocation (left or right) was determined using block randomization with a fixed block size of two, implemented via an online randomization tool (www.sealedenvelope.com). The randomization sequence was generated in advance by an independent biostatistician who was not involved in patient care or data analysis.
Treatment allocation was concealed using sequentially numbered, opaque, sealed envelopes (SNOSE), which were prepared by an independent biostatistician not involved in patient care or outcome assessment. At the time of enrollment, a study coordinator opened the next envelope in sequence to determine which eye would receive the combined treatment. The contralateral eye automatically received cyclosporine A monotherapy.
To maintain masking, the ophthalmologists responsible for outcome assessment (including ocular surface staining, tear film measurements, and in vivo confocal microscopy) were blinded to the treatment allocation. Participants were informed that both eyes would receive active treatment and were not informed of the specific allocation. The investigators performing plug insertion and administering cyclosporine A were not involved in any clinical evaluations.
A total of 30 patients with Sjögren's syndrome-associated dry eye (SSDE) were planned for enrollment. The sample size calculation was based on a paired-eye design, in which each participant served as their own control. The calculation assumed a two-sided significance level of 0.05 (α = 0.05) and a statistical power of 95% (β = 0.05), aiming to detect a clinically meaningful difference in ocular surface parameters (e.g., tear breakup time or symptom scores) between the two eyes. The estimated required sample size accounted for potential dropouts and was deemed sufficient to identify within-subject differences while minimizing variability due to inter-individual factors such as disease severity, lifestyle, and systemic autoimmune status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Other | Drug: 0.05% Cyclosporine Eye DropsOne eye was randomized to recieve a Smart plug absorbable lacrimal duct plugs, and cyclosporin A 0.05% cyclosporine A eye drops were administered three times daily to both eyes. |
| Control group | Other | Drug: 0.05% Cyclosporine Eye Drops, Device: Smart plug absorbable lacrimal duct plugscyclosporin A 0.05% cyclosporine A eye drops were administered three times daily to both eyes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- The patients aged ≥18 years who had a confirmed diagnosis of Sjögren's syndrome (SS).
- Dry eye diagnosis required both subjective and objective criteria: participants presented with one or more ocular surface symptoms such as dryness, foreign body sensation, burning, fatigue, discomfort, redness, or fluctuating vision, with an Ocular Surface Disease Index (OSDI) score of ≥13; Noninvasive Tear Break-Up Time (NIBUT)≤10s and Schirmer I test≤ 5 mm/5 min
- voluntarily participate in this study and sign written informed consent
Key exclusion criteria (11 listed)
- Any patient with structural abnormalities (eyelid scars, entropion, trichiasis, etc.);
- Patients with any inflammation or active structural changes in the iris or anterior chamber;
- Glaucoma;
- Patients who have undergone previous ophthalmic surgery or have undergone timely closure;
- Patients using any topical medications other than artificial tears, 0.1% flumirone eye drops, and 0.05% cyclosporine A eye drops;
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 |
|---|---|---|
| 0.05% Cyclosporine Eye DropsCyclosporin A 0.05% eye drops were administered twice daily to both eyes | Drug | Control group, Experimental group |
| Smart plug absorbable lacrimal duct plugsThe lacrimal duct embolization implant is performed by partially sealing the tear discharge duct to increase the lubrication of natural tears on the eye surface. | Device | Control group |
Primary outcome
The Ocular Surface Disease Index (OSDI) score
Time frame: Assessed after 3 months of the trial
The Ocular Surface Disease Index (OSDI) is a tool used for screening and diagnosing patients with dry eye syndrome. It assesses the severity of dry eye, covering three dimensions: ocular symptoms, visual function and environmental triggers
VAS score
Time frame: Assessed after 3 months of the trial
A swimming ruler of about 10cm in length was used, with 10 scales on one side and "0" and "10" ends, respectively, with 0 indicating no pain and 10 indicating the most severe pain that was unbearable.
BUT
Time frame: Assessed after 6 months of the trial
Tear film break-up time,It is a tear stability test
tear river height
Time frame: Assessed after 6 months of the trial
The concave arc formed at the junction of tears and eyelid margin was observed under a slit lamp microscope, and the tear secretion was indirectly evaluated by measuring the tear retention height
IVCM examination
Time frame: Assessed after 6 months of the trial
It can observe the physiological and pathological changes of ocular surface tissues and cell structures in vivo, and has wide applications in the diagnosis and treatment evaluation of infectious keratitis, ocular surface assessment of dry eye disease, evaluation of the therapeutic effect of ocular surface surgery, and early screening of diabetes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Derived from this study: PubMed 41567664Dong Y, Cao JF, Li ZC, Yang XY, Chen L. Enhanced efficacy of 0.05% cyclosporine a combined with absorbable punctal plugs in Sjogren's syndrome-associated dry eye: a paired-eye clinical trial. Front Med (Lausanne). 2026 Jan 6;12:1674647. doi: 10.3389/fmed.2025.1674647. eCollection 2025.
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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.
Yi Zhang study director
Tianjin Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.05% Cyclosporine Eye Drops and Smart plug absorbable lacrimal duct plugs in people with Dry Eye Disease, run by Tianjin Eye 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 3 inclusion and 11 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 12 Sep 2025. 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?
Results are not available in the source record.
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?
The Ocular Surface Disease Index (OSDI) score (time frame: Assessed after 3 months of the trial). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07171710, which also lists 1 linked publication.
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 12 Sep 2025.