NCT07171710

Efficacy of 0.05% Cyclosporine A Eye Drops Combined With Absorbable Tear Duct Plugs in the Treatment of Dry Eye in Sjögren's Syndrom

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tianjin Eye Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	0.05% Cyclosporine Eye Drops	Cyclosporin A 0.05% eye drops were administered twice daily to both eyes
DEVICE	Smart plug absorbable lacrimal duct plugs	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.

Timeline

• Start date: 2024-03-01
• Primary completion: 2026-03-01
• Completion: 2026-03-31
• First posted: 2025-09-12
• Last updated: 2025-09-12

Locations

1 site across 1 country: China