Tear Film Stability and Improvement of Asthenopia: Efficacy Observation of 0.05% Cyclosporine in Dry Eye Patients With Short BUT

NCT ID: NCT06981104

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-18
• Study Completion Date: 2025-02-14

Brief Summary

At present, research on cyclosporine mainly focuses on patients with moderate to severe dry eye. Based on the importance of the vicious cycle of inflammation in the pathogenesis of dry eye and the mechanism of cyclosporine, investigators believe that it may also have therapeutic effects in patients with mild to moderate dry eye, and may have certain advantages compared to traditional artificial tear therapy. In summary, this study intends to use a randomized, double-blind, parallel controlled trial to evaluate the therapeutic efficacy and safety of 0.05% cyclosporine eye drops in patients with mild to moderate dry eyes.

Conditions

Dry Eye Disease (DED); Asthenopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

0.05% cyclosporine froup(Group C)

Group Type: EXPERIMENTAL

0.05% cyclosporine eyedrops

Intervention Type: DRUG

0.05% cyclosporine, one drop each time, twice a day

0.1% sodium hyaluronate group（Group S）

Group Type: PLACEBO_COMPARATOR

0.1% sodium hyaluronate eye drop

Intervention Type: DRUG

0.1% sodium hyaluronate, one drop each time, three times a day

Interventions

0.05% cyclosporine eyedrops

0.05% cyclosporine, one drop each time, twice a day

Intervention Type: DRUG

0.1% sodium hyaluronate eye drop

0.1% sodium hyaluronate, one drop each time, three times a day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 18-75 years old (including 18 and 75 years old), male or female;

2. Meets the diagnostic criteria for dry eye syndrome in China (2020) and is mild dry eye 1) Dry Eye Questionnaire (OSDI) score ≥ 13 points; 2) BUT ≤ 10 seconds or Schirmer I ≤ 5mm/5 minutes 3) Corneal staining positive ≤ 5 points.

3. At least one of OSDI, BUT, and Schirmer I meets the moderate standard OSDI ≥ 23 points; BUT<5 seconds; Schirmer I < 5mm/5min

4. The subjects themselves signed an informed consent form and voluntarily participated in this study.

Exclusion Criteria

1. Women who are breastfeeding or pregnant, or men and women of childbearing age who are unable to use effective contraceptive methods during the study period;

2. Those who need to wear contact lenses during treatment;

3. Acute inflammation, infection, allergy, and trauma of the eyes;

4. There are obvious scars or keratinization on the eyelid margin;

5. Have undergone eye or eyelid surgery within the 6 months prior to enrollment;

6. Diagnosed with facial nerve paralysis or ocular nerve paralysis within 6 months prior to enrollment;

7. Currently using lacrimal duct embolization (permanent lacrimal plug or treatment with lacrimal plug within 6 months);

8. I am currently taking medication that may affect dry eye syndrome.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

1 Xihu Avenue, Shangcheng District, Hangzhou, Zhejiang, China

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

2024-0146

Identifier Type: -

Identifier Source: org_study_id