Status:
COMPLETED
Tear Film Stability and Improvement of Asthenopia: Efficacy Observation of 0.05% Cyclosporine in Dry Eye Patients With Short BUT
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Dry Eye Disease (DED)
Asthenopia
Eligibility:
All Genders
18+ years
Phase:
NA
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 mec...
Eligibility Criteria
Inclusion
- 18-75 years old (including 18 and 75 years old), male or female;
- 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.
- At least one of OSDI, BUT, and Schirmer I meets the moderate standard OSDI ≥ 23 points; BUT\<5 seconds; Schirmer I \< 5mm/5min
- The subjects themselves signed an informed consent form and voluntarily participated in this study.
Exclusion
- 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;
- Those who need to wear contact lenses during treatment;
- Acute inflammation, infection, allergy, and trauma of the eyes;
- There are obvious scars or keratinization on the eyelid margin;
- Have undergone eye or eyelid surgery within the 6 months prior to enrollment;
- Diagnosed with facial nerve paralysis or ocular nerve paralysis within 6 months prior to enrollment;
- Currently using lacrimal duct embolization (permanent lacrimal plug or treatment with lacrimal plug within 6 months);
- I am currently taking medication that may affect dry eye syndrome.
Key Trial Info
Start Date :
November 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06981104
Start Date
November 18 2024
End Date
February 14 2025
Last Update
November 20 2025
Active Locations (1)
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1
1 Xihu Avenue, Shangcheng District, Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China