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

Not Applicable

Completed

• Conditions: Dry Eye Disease (DED); Asthenopia
• Interventions: Drug: 0.05% cyclosporine eyedrops; Drug: 0.1% sodium hyaluronate eye drop

• Registration Number: NCT06981104
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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, we 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-11-18
• Primary Completion: 2025-02-14
• Study Completion: 2025-02-14
• Study First Submitted: 2025-05-12
• Study First Submitted QC: 2025-05-12
• Last Update Submitted: 2025-05-12
• Study First Posted: 2025-05-20
• Last Update Posted: 2025-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.05% cyclosporine froup(Group C)	0.05% cyclosporine eyedrops	-
0.1% sodium hyaluronate group（Group S）	0.1% sodium hyaluronate eye drop	-

Primary Outcome Measures

Name	Time	Method
Fluorescent tear film breakup time	8weeks
high-frequency component（HFC）	8weeks
visual fatigue index	8weeks

Trial Locations

Locations (1)

1 Xihu Avenue, Shangcheng District, Hangzhou, Zhejiang, China; 🇨🇳 Hangzhou, Zhejiang, China