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

NCT ID: NCT07171710

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2026-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

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.

Group Type: OTHER

0.05% Cyclosporine Eye Drops

Intervention Type: DRUG

Cyclosporin A 0.05% eye drops were administered twice daily to both eyes

Control group

cyclosporin A 0.05% cyclosporine A eye drops were administered three times daily to both eyes.

Group Type: OTHER

0.05% Cyclosporine Eye Drops

Intervention Type: DRUG

Cyclosporin A 0.05% eye drops were administered twice daily to both eyes

Smart plug absorbable lacrimal duct plugs

Intervention Type: DEVICE

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.

Interventions

0.05% Cyclosporine Eye Drops

Cyclosporin A 0.05% eye drops were administered twice daily to both eyes

Intervention Type: DRUG

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. The patients aged ≥18 years who had a confirmed diagnosis of Sjögren's syndrome (SS).

2. 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

3. voluntarily participate in this study and sign written informed consent

Exclusion Criteria

1. Any patient with structural abnormalities (eyelid scars, entropion, trichiasis, etc.);

2. Patients with any inflammation or active structural changes in the iris or anterior chamber;

3. Glaucoma;

4. Patients who have undergone previous ophthalmic surgery or have undergone timely closure;

5. Patients using any topical medications other than artificial tears, 0.1% flumirone eye drops, and 0.05% cyclosporine A eye drops;

6. Patients who received any systemic or topical antibacterial or anti-inflammatory drug treatment 90 days before the start of the study;

7. Patients wearing contact lenses;

8. Patients with corneal infection;

9. Corneal diseases (marginal ulcers, opacity, scars, bullous keratopathy, conjunctival laxity, eyelid ball adhesions or tumors);

10. Pregnancy;

11. Study the changes of immunosuppressive system treatment in the first 90 days.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Eye Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yi Zhang

Role: STUDY_DIRECTOR

Tianjin Eye Hospital

Locations

Tianjin Eye Hospital

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

zhangyi2024-1

Identifier Type: -

Identifier Source: org_study_id