An interventional study of 0.05% Cyclosporine Eye Drops and Smart plug absorbable lacrimal duct plugs in Dry Eye Disease, sponsored by Tianjin Eye Hospital. Enrolling by invitation at 1 site in China. Per ClinicalTrials.gov, last updated 2025-09-12.
Sponsored by Tianjin Eye Hospital · Not applicable, Interventional, and Treatment
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.
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.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Tianjin Eye Hospital is the lead sponsor of 49 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: 0.05% Cyclosporine Eye Drops
cyclosporin A 0.05% cyclosporine A eye drops were administered three times daily to both eyes.
Drug: 0.05% Cyclosporine Eye Drops · Device: Smart plug absorbable lacrimal duct plugs
Cyclosporin A 0.05% eye drops were administered twice daily to both eyes
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.
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
Time frame: 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.
Time frame: Assessed after 3 months of the trial
BUT
Tear film break-up time,It is a tear stability test
Time frame: 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
Time frame: 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.
Time frame: Assessed after 6 months of the trial
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tianjin Eye Hospital